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CompletedNCT01198145Updated May 12, 2020Results posted

Sulfasalazine in Preventing Acute Diarrhea in Patients With Cancer Who Are Undergoing Pelvic Radiation Therapy

A Phase 3 interventional study of sulfasalazine and placebo in Diarrhea, Gastrointestinal Complications and Unspecified Adult Solid Tumor, Protocol Specific, sponsored by Alliance for Clinical Trials in Oncology. Completed at 257 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-05-12.

Sponsored by Alliance for Clinical Trials in Oncology · Phase 3, Interventional, and Supportive care

Phase
Phase 3
Study type
Interventional
Enrollment
87
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

RATIONALE: Sulfasalazine may relieve diarrhea in patients with cancer who are undergoing pelvic radiation therapy.

PURPOSE: This randomized phase III trial is studying sulfasalazine to see how well it works in preventing acute diarrhea in patients with cancer who are undergoing pelvic radiation therapy.

Read the detailed description

OBJECTIVES:

Primary

  • To determine whether sulfasalazine is effective in reducing the acute treatment-related diarrhea in patients receiving pelvic radiotherapy as measured by NCI CTC v4.0 in patients receiving pelvic external-beam radiotherapy as adjuvant or primary treatment for malignancy.

Secondary

  • To determine whether sulfasalazine can reduce chronic treatment-related bowel dysfunction following completion of therapy.
  • To determine whether sulfasalazine causes any toxicity in this situation.

Tertiary

  • To bank blood products for future studies, as part of ongoing research for NCCTG studies (Mayo Clinic Rochester only). (Translational)

OUTLINE: This is a multicenter study. Patients are stratified according to history of anterior resection of the rectum (yes vs no); total planned cumulative dosing, including boost fields of external-beam radiotherapy (4500-5350 cGy vs > 5350 cGy); and concurrent radiosensitizing fluorouracil, capecitabine, or oxaliplatin (yes vs no). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral sulfasalazine twice daily during radiotherapy* and for 4 weeks after completion of radiotherapy.
  • Arm II: Patients receive oral placebo twice daily during radiotherapy* and for 4 weeks after completion of radiotherapy.

NOTE: *Patients must start study treatment by the third radiotherapy fraction.

Patients may undergo blood sample collection at baseline and then weekly during radiotherapy. All patients complete quality of life and bowel function questionnaires at baseline, weekly during radiotherapy, and at 6 weeks after completion of radiotherapy.

After completion of radiotherapy, patients are followed up at 6 weeks and at 12 and 24 months.

02

Conditions studied

  • Diarrhea
  • Gastrointestinal Complications
  • Unspecified Adult Solid Tumor, Protocol Specific

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Keywords

  • diarrhea
  • gastrointestinal complications
  • unspecified adult solid tumor, protocol specific
03

In context

Diarrhea

852 studies on the registry are indexed under Diarrhea; 78 are open to participants now.

This study's enrollment of 87 is below the median of 136 across 713 interventional studies indexed under Diarrhea.

Browse Diarrhea studies →

Lead sponsor

Alliance for Clinical Trials in Oncology is the lead sponsor of 499 studies on the registry; 27 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of cancer that supports the use of radiotherapy to the pelvis
  • No current or prior metastases beyond pelvic regional lymph nodes
  • Planning to receive a course of continuous definitive or adjuvant external-beam radiotherapy to a minimum dose of 4500 cGy with or without fluorouracil, capecitabine, or oxaliplatin

  • Planned course of pelvic radiotherapy must fall within the following parameters:

    • Pelvis must be encompassed by the planned radiotherapy fields

      • Superior border may not lie superior to the L4-5 interspace and may not be inferior to the most inferior aspect of the sacroiliac joints
      • Portions of the rectum may have special blocking, depending upon disease site

    • Total planned dose to the central axis midplane (for AP-PA parallel opposed fields) or isocenter (for 3- or 4-field techniques) for the pelvic field must lie between 4500-5300 cGy (inclusive)*

      • Subsequent to completion of treatment to the pelvic field, a boost to primary tumor or tumor bed may be planned

    • Planned treatment is to be given 4-5 times per week on a one-treatment-per-day basis

      • Daily dose (specified at central axis midplane or at isocenter for multi-field techniques) must lie between 170-210 cGy (inclusive) per day*
  • NOTE: *For institutions that do not use midplane or isocenter as the point for specification of dose, it will be necessary to determine the dose according to the methods specified above in order to determine patient eligibility.
  • No perineal irradiation planned (e.g., anal cancer patients, patients who have had an abdominal-perineal resection)
  • No brachytherapy planned before the completion of all external-beam radiotherapy
  • No planned split-course radiotherapy

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Life expectancy ≥ 6 months
  • Hemoglobin ≥ 10.0 g/dL
  • Leukocytes ≥ 3,500/mm\^3
  • ANC ≥ 1,500/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • Creatinine ≤ 1.5 times upper limit of normal (ULN)
  • AST ≤ 1.5 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Willing to provide blood specimens as required by the study (Mayo Clinic Rochester patients only)
  • Able to complete questionnaires alone or with assistance
  • No history of inflammatory bowel disease
  • No history of gastrointestinal or genitourinary obstruction or porphyria
  • No history of G6PD deficiency
  • No history of irritable bowel syndrome
  • No history of blood dyscrasia
  • No history of severe allergies or asthma
  • No history of hepatic or renal disease
  • No diarrhea ≥ grade 3, rectal bleeding, abdominal cramping, or incontinence of stool within the past week
  • No medical condition that may interfere with the ability to receive study treatment
  • No known allergy to sulfasalazine, sulfa medications, salicylates, or any known component of drug formulation

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior pelvic radiotherapy
  • No prior abdominal-perineal resection, Hartmann procedure, or other surgical procedure leaving the patient without a functioning rectum
  • No planned use of leucovorin or cytotoxic chemotherapeutic agents concurrent with radiotherapy (except for fluorouracil, capecitabine, or oxaliplatin)
  • No other concurrent sulfasalazine
  • No concurrent digoxin
05

Study design

Phase
Phase 3
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
87 participants (actual)

Study arms

  • Experimental
    Arm I: Sulfasalazine

    Patients receive oral sulfasalazine twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.

    Drug: sulfasalazine

  • Placebo comparator
    Arm II: Placebo

    Patients receive oral placebo twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.

    Other: placebo

Interventions

  • Drugsulfasalazine

    Given orally

  • Otherplacebo

    Given orally

06

What researchers measure

Primary outcomes

  1. Maximum Severity of Diarrhea Toxicity as Measured by the CTCAE v4.0 During and After Radiotherapy (RT)

    The primary endpoint for this study is the maximal severity of diarrhea toxicity. Severity of diarrhea was graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 4.0. Grade 0 = None; 1=Mild; Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening as measured by the CTCAE version 4.0. Assessments were recorded during the course of RT and for 6 weeks following RT. The table below represents the worst graded diarrhea for each patient. A two-sided Wilcoxon rank-sum test will be used to test the equality of the distributions of maximum diarrhea severity grades between the two treatment arms.

    Time frame: During radiation therapy and up to 6 weeks post radiation therapy

Secondary outcomes

  1. Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT

    The maximal severity of each of 5 different adverse even types (Tenesmus, Abdominal Pain, Constipation, Diarrhea, and Rectal Bleeding) were collected as a secondary endpoint. Severity of the events was graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 4.0. Grade 0 = None; 1=Mild; Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening. Adverse events were assessed during the course of RT and for 6 weeks following RT. The table below represents the worst grade for each patient for each type. Two-sided chi-square tests will be used to compare each percentage variable between treatment arms for each event type.

    Time frame: During radiation therapy and up to 6 weeks post radiation therapy

  2. Area Under the Curve That Combines the Individual Severity of Diarrhea Toxicity as Measured by the CTCAE v4.0 During and After RT

    For each patient, an Area Under the Curve (AUC) summary statistic will be calculated taking into account the individual severity of diarrhea toxicity over time. Severity of diarrhea was graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 4.0. Grade 0 = None; 1=Mild; Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening. The curve was constructed using weekly assessments during and after RT. A separate analysis was done during the course of RT and every week for 6 weeks following RT.

    Time frame: During radiation therapy and up to 6 weeks post radiation therapy

  3. Average Graded Severity for Tenesmus, Abdominal Pain, Constipation, Diarrhea and Hemorrhage During and After RT as Graded by CTCAE v4.0

    Tenesmus, Abdominal pain, constipation, diarrhea and hemorrhaging were assessed during RT and up to 6 weeks after RT. Severity of these events were graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 4.0. Grade 0 = None; 1=Mild; Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening. For each patient, an average score for each outcome variable during and after RT calculated as follows: The sum of all severity scores for that variable divided by the number of severity scores for that variable recorded for the patient during the course of RT and for 6 weeks following RT.

    Time frame: During radiation therapy and up to 6 weeks post radiation therapy

  4. Percentage of Patients in Each Arm That Experience Tenesmus, Abdominal Pain, Constipation, Diarrhea and Rectal Bleeding During and After RT

    The number of patients that reported any grade 1 or higher adverse event was divided by the total number of patients evaluated. The analysis was done separately for each of the 5 outcomes and separately during RT and after RT.

    Time frame: During radiation therapy and up to 6 weeks post radiation therapy

  5. Percent of Patients in Each Arm That Recorded "Yes" to Each of Questions 2-10 on the Bowel Function Questionnaire

    Questions that were used in this analysis: 2. Have you had a problem causing you to get up at night to have a bowel movement? 3. Have you had a problem causing you to lose control of your bowel movements? 4. Have you had a problem causing you to have a bowel movement within 30 minutes of a prior bowel movement? 5. Have you had to wear protective clothing or a pad in case you lost control of a bowel movement? 6. Have you had a problem causing you to be unable to tell the difference between stool and gas? 7. Have you had a problem causing you to have stools that are liquid? 1=yes 2=no q08 8. Have you found that once you feel the urge to have a bowel movement, you must do so within 15 minutes to avoid an accident? 9. Have you had cramping with a bowel movement? 10. Have you had blood in your bowel movement?

    Time frame: Up to 6 weeks post radiation therapy

  6. Percentage of Patients in Each Arm That Require Any Type of Antidiarrheal Medications.

    The number of patients reporting the use of anti-diarrheal medications divided by the number of patients evaluated for this endpoint.

    Time frame: Up to 24 months post radiotherapy

  7. Percentage of Patients in Each Arm That Experience Clinically Significant Deficits in Overall Quality of Life and Fatigue

    For each arm, the percentage of patients experience clinically significant deficits in overall QOL and fatigue as indicated by a score of 5 or lower on the 0-10 scale. The analysis was done using the questionnaire that was completed during the first week of radiotherapy (RT) and 6 weeks after RT.

    Time frame: Up to 6 weeks post radiotherapy

07

Results

Posted Apr 4, 2017

Participant flow

Participant flow — Overall Study
MilestoneArm I: SulfasalazineArm II: Placebo
Started4443
Completed4342
Not completed11
Withdrew: Withdrawal by subject11

Outcome measures

PrimaryMaximum Severity of Diarrhea Toxicity as Measured by the CTCAE v4.0 During and After Radiotherapy (RT)

The primary endpoint for this study is the maximal severity of diarrhea toxicity. Severity of diarrhea was graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 4.0. Grade 0 = None; 1=Mild; Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening as measured by the CTCAE version 4.0. Assessments were recorded during the course of RT and for 6 weeks following RT. The table below represents the worst graded diarrhea for each patient. A two-sided Wilcoxon rank-sum test will be used to test the equality of the distributions of maximum diarrhea severity grades between the two treatment arms.

Time frame:
During radiation therapy and up to 6 weeks post radiation therapy
Reported as:
Count of participants · Participants
Maximum Severity of Diarrhea Toxicity as Measured by the CTCAE v4.0 During and After Radiotherapy (RT)
ParticipantsArm I: SulfasalazineArm II: Placebo
Grade 01010
Grade 11315
Grade 2813
Grade 3104
Grade 410
Statistical analysis
  • Arm I: Sulfasalazine vs Arm II: Placebo · Wilcoxon (Mann-Whitney) · p = 0.41
SecondaryMaximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT

The maximal severity of each of 5 different adverse even types (Tenesmus, Abdominal Pain, Constipation, Diarrhea, and Rectal Bleeding) were collected as a secondary endpoint. Severity of the events was graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 4.0. Grade 0 = None; 1=Mild; Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening. Adverse events were assessed during the course of RT and for 6 weeks following RT. The table below represents the worst grade for each patient for each type. Two-sided chi-square tests will be used to compare each percentage variable between treatment arms for each event type.

Time frame:
During radiation therapy and up to 6 weeks post radiation therapy
Reported as:
Count of participants · Participants
Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT
ParticipantsArm I: SulfasalazineArm II: Placebo
Tenesmus during RT — Grade 02730
Tenesmus during RT — Grade 169
Tenesmus during RT — Grade 273
Tenesmus during RT — Grade 320
Tenesmus during RT — Grade 400
Tenesmus after RT — Grade 01821
Tenesmus after RT — Grade 157
Tenesmus after RT — Grade 201
Tenesmus after RT — Grade 300
Tenesmus after RT — Grade 400
Abdominal pain during RT — Grade 02226
Abdominal pain during RT — Grade 11412
Abdominal pain during RT — Grade 234
Abdominal pain during RT — Grade 330
Abdominal pain during RT — Grade 400
Abdominal pain after RT — Grade 01724
Abdominal pain after RT — Grade 182
Abdominal pain after RT — Grade 203
Abdominal pain after RT — Grade 300
Abdominal pain after RT — Grade 400
Constipation during RT — Grade 02627
Constipation during RT — Grade 11213
Constipation during RT — Grade 242
Constipation during RT — Grade 300
Constipation during RT — Grade 400
Constipation after RT — Grade 01922
Constipation after RT — Grade 166
Constipation after RT — Grade 201
Constipation after RT — Grade 300
Constipation after RT — Grade 400
Diarrhea during RT — Grade 01011
Diarrhea during RT — Grade 11314
Diarrhea during RT — Grade 2913
Diarrhea during RT — Grade 394
Diarrhea during RT — Grade 410
Diarrhea after RT — Grade 01114
Diarrhea after RT — Grade 11210
Diarrhea after RT — Grade 223
Diarrhea after RT — Grade 302
Diarrhea after RT — Grade 400
Rectal bleeding during RT — Grade 02622
Rectal bleeding during RT — Grade 11620
Rectal bleeding during RT — Grade 200
Rectal bleeding during RT — Grade 300
Rectal bleeding during RT — Grade 400
Rectal bleeding after RT — Grade 02027
Rectal bleeding after RT — Grade 152
Rectal bleeding after RT — Grade 200
Rectal bleeding after RT — Grade 300
Rectal bleeding after RT — Grade 400
Statistical analysis
  • Arm I: Sulfasalazine vs Arm II: Placebo · Chi-squared · p = 0.23
  • Arm I: Sulfasalazine vs Arm II: Placebo · Chi-squared · p = 0.64
  • Arm I: Sulfasalazine vs Arm II: Placebo · Chi-squared · p = 0.30
  • Arm I: Sulfasalazine vs Arm II: Placebo · Chi-squared · p = 0.02
  • Arm I: Sulfasalazine vs Arm II: Placebo · Chi-squared · p = 0.70
  • Arm I: Sulfasalazine vs Arm II: Placebo · Chi-squared · p = 0.63
  • Arm I: Sulfasalazine vs Arm II: Placebo · Chi-squared · p = 0.44
  • Arm I: Sulfasalazine vs Arm II: Placebo · Chi-squared · p = 0.48
  • Arm I: Sulfasalazine vs Arm II: Placebo · Chi-squared · p = 0.38
  • Arm I: Sulfasalazine vs Arm II: Placebo · Chi-squared · p = 0.15
SecondaryArea Under the Curve That Combines the Individual Severity of Diarrhea Toxicity as Measured by the CTCAE v4.0 During and After RT

For each patient, an Area Under the Curve (AUC) summary statistic will be calculated taking into account the individual severity of diarrhea toxicity over time. Severity of diarrhea was graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 4.0. Grade 0 = None; 1=Mild; Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening. The curve was constructed using weekly assessments during and after RT. A separate analysis was done during the course of RT and every week for 6 weeks following RT.

Time frame:
During radiation therapy and up to 6 weeks post radiation therapy
Reported as:
Mean · grade*week
Area Under the Curve That Combines the Individual Severity of Diarrhea Toxicity as Measured by the CTCAE v4.0 During and After RT
grade*weekArm I: SulfasalazineArm II: Placebo
During RT4.0 ± 3.93.3 ± 3.0
After RT1.2 ± 1.71.3 ± 2.4
Statistical analysis
  • Arm I: Sulfasalazine vs Arm II: Placebo · Wilcoxon (Mann-Whitney) · p = 0.56
  • Arm I: Sulfasalazine vs Arm II: Placebo · Wilcoxon (Mann-Whitney) · p = 0.74
SecondaryAverage Graded Severity for Tenesmus, Abdominal Pain, Constipation, Diarrhea and Hemorrhage During and After RT as Graded by CTCAE v4.0

Tenesmus, Abdominal pain, constipation, diarrhea and hemorrhaging were assessed during RT and up to 6 weeks after RT. Severity of these events were graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 4.0. Grade 0 = None; 1=Mild; Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening. For each patient, an average score for each outcome variable during and after RT calculated as follows: The sum of all severity scores for that variable divided by the number of severity scores for that variable recorded for the patient during the course of RT and for 6 weeks following RT.

Time frame:
During radiation therapy and up to 6 weeks post radiation therapy
Reported as:
Mean · Average Grade of Event
Average Graded Severity for Tenesmus, Abdominal Pain, Constipation, Diarrhea and Hemorrhage During and After RT as Graded by CTCAE v4.0
Average Grade of EventArm I: SulfasalazineArm II: Placebo
Tenesmus during RT0.2 ± 0.40.1 ± 0.2
Tenesmus after RT0.1 ± 0.20.1 ± 0.4
Abdominal pain during RT0.3 ± 0.40.2 ± 0.3
Abdominal pain after RT0.2 ± 0.30.2 ± 0.4
Constipation during RT0.2 ± 0.30.2 ± 0.3
Constipation after RT0.1 ± 0.30.1 ± 0.2
Diarrhea during RT0.8 ± 0.70.6 ± 0.6
Diarrhea after RT0.3 ± 0.40.3 ± 0.4
Rectal bleeding during RT0.2 ± 0.30.2 ± 0.3
Rectal bleeding after RT0.1 ± 0.30.1 ± 0.2
SecondaryPercentage of Patients in Each Arm That Experience Tenesmus, Abdominal Pain, Constipation, Diarrhea and Rectal Bleeding During and After RT

The number of patients that reported any grade 1 or higher adverse event was divided by the total number of patients evaluated. The analysis was done separately for each of the 5 outcomes and separately during RT and after RT.

Time frame:
During radiation therapy and up to 6 weeks post radiation therapy
Reported as:
Number · percentage of participants
Percentage of Patients in Each Arm That Experience Tenesmus, Abdominal Pain, Constipation, Diarrhea and Rectal Bleeding During and After RT
percentage of participantsArm I: SulfasalazineArm II: Placebo
Tenesmus during RT35.728.6
Tenesmus after RT11.919.1
Abdominal pain during RT47.638.1
Abdominal pain after RT19.111.9
Constipation during RT38.135.7
Constipation after RT14.316.7
Diarrhea during RT76.273.8
Diarrhea after RT33.335.7
Rectal bleeding during RT38.147.6
Rectal bleeding after RT11.94.8
SecondaryPercent of Patients in Each Arm That Recorded "Yes" to Each of Questions 2-10 on the Bowel Function Questionnaire

Questions that were used in this analysis: 2. Have you had a problem causing you to get up at night to have a bowel movement? 3. Have you had a problem causing you to lose control of your bowel movements? 4. Have you had a problem causing you to have a bowel movement within 30 minutes of a prior bowel movement? 5. Have you had to wear protective clothing or a pad in case you lost control of a bowel movement? 6. Have you had a problem causing you to be unable to tell the difference between stool and gas? 7. Have you had a problem causing you to have stools that are liquid? 1=yes 2=no q08 8. Have you found that once you feel the urge to have a bowel movement, you must do so within 15 minutes to avoid an accident? 9. Have you had cramping with a bowel movement? 10. Have you had blood in your bowel movement?

Time frame:
Up to 6 weeks post radiation therapy
Reported as:
Number · percentage of participants
Percent of Patients in Each Arm That Recorded "Yes" to Each of Questions 2-10 on the Bowel Function Questionnaire
percentage of participantsArm I: SulfasalazineArm II: Placebo
During RT : Q21910
During RT : Q31110
During RT : Q43333
During RT : Q570
During RT : Q62623
During RT : Q71120
During RT : Q84443
During RT : Q9417
During RT : Q1077
After RT : Q23927
After RT : Q32422
After RT : Q45556
After RT : Q51812
After RT : Q63746
After RT : Q73737
After RT : Q87061
After RT : Q93434
After RT : Q105029
SecondaryPercentage of Patients in Each Arm That Require Any Type of Antidiarrheal Medications.

The number of patients reporting the use of anti-diarrheal medications divided by the number of patients evaluated for this endpoint.

Time frame:
Up to 24 months post radiotherapy
Reported as:
Number · percentage of participants
Percentage of Patients in Each Arm That Require Any Type of Antidiarrheal Medications.
percentage of participantsArm I: SulfasalazineArm II: Placebo
Percentage of Patients in Each Arm That Require Any Type of Antidiarrheal Medications.48.728.6
SecondaryPercentage of Patients in Each Arm That Experience Clinically Significant Deficits in Overall Quality of Life and Fatigue

For each arm, the percentage of patients experience clinically significant deficits in overall QOL and fatigue as indicated by a score of 5 or lower on the 0-10 scale. The analysis was done using the questionnaire that was completed during the first week of radiotherapy (RT) and 6 weeks after RT.

Time frame:
Up to 6 weeks post radiotherapy
Reported as:
Number · percentage of participants
Percentage of Patients in Each Arm That Experience Clinically Significant Deficits in Overall Quality of Life and Fatigue
percentage of participantsArm I: SulfasalazineArm II: Placebo
During RT17.97.5
After RT26.927.6

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Arm I: Sulfasalazine—1/43 (2.3%)42/43 (97.7%)
Arm II: Placebo—2/42 (4.8%)40/42 (95.2%)
Most frequent serious events
Most frequent serious events
EventArm I: SulfasalazineArm II: Placebo
AnemiaBlood and lymphatic system disorders0/431/42
ConstipationGastrointestinal disorders0/431/42
Gastrointestinal disorders - Other, specifyGastrointestinal disorders0/431/42
TenesmusGastrointestinal disorders0/431/42
Abdominal painGastrointestinal disorders1/430/42
Most frequent other events
Showing 10 of 39
Most frequent other events
EventArm I: SulfasalazineArm II: Placebo
DiarrheaGastrointestinal disorders33/4332/42
Abdominal painGastrointestinal disorders15/4322/42
White blood cell decreasedInvestigations8/4318/42
AnemiaBlood and lymphatic system disorders15/4317/42
Lower gastrointestinal hemorrhageGastrointestinal disorders17/4315/42
TenesmusGastrointestinal disorders17/4316/42
ConstipationGastrointestinal disorders15/4315/42
Platelet count decreasedInvestigations4/438/42
Lymphocyte count decreasedInvestigations2/437/42
Neutrophil count decreasedInvestigations4/436/42

Baseline characteristics

Two patients in Arm I and one patient from Arm II were not included in the baseline analysis nor the endpoint analyses due to cancellations and protocol violations.

Age, Continuous
Age, Continuous(years)Arm I: SulfasalazineArm II: PlaceboTotal
Median59 (37 to 84)56.5 (37 to 81)58 (37 to 84)
Sex: Female, Male
Sex: Female, Male(Participants)Arm I: SulfasalazineArm II: PlaceboTotal
Female151833
Male272451
Region of Enrollment
Region of Enrollment(participants)Arm I: SulfasalazineArm II: PlaceboTotal
United States424284
08

Study locations

257 sites
  • Mayo Clinic Hospital
    Phoenix, Arizona 85054, United States
  • Mayo Clinic Scottsdale
    Scottsdale, Arizona 85259-5499, United States
  • Aurora Presbyterian Hospital
    Aurora, Colorado 80012, United States
  • Boulder Community Hospital
    Boulder, Colorado 80301-9019, United States
  • Penrose Cancer Center at Penrose Hospital
    Colorado Springs, Colorado 80933, United States
  • St. Anthony Central Hospital
    Denver, Colorado 80204, United States
  • Porter Adventist Hospital
    Denver, Colorado 80210, United States
  • Presbyterian - St. Luke's Medical Center
    Denver, Colorado 80218, United States
  • St. Joseph Hospital
    Denver, Colorado 80218, United States
  • Rose Medical Center
    Denver, Colorado 80220, United States
  • Swedish Medical Center
    Englewood, Colorado 80110, United States
  • North Colorado Medical Center
    Greeley, Colorado 80631, United States
  • Sky Ridge Medical Center
    Lone Tree, Colorado 80124, United States
  • Hope Cancer Care Center at Longmont United Hospital
    Longmont, Colorado 80501, United States
  • McKee Medical Center
    Loveland, Colorado 80539, United States
  • St. Mary - Corwin Regional Medical Center
    Pueblo, Colorado 81004, United States
  • North Suburban Medical Center
    Thornton, Colorado 80229, United States
  • Exempla Lutheran Medical Center
    Wheat Ridge, Colorado 80033, United States
  • Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
    Hartford, Connecticut 06105, United States
  • Tunnell Cancer Center at Beebe Medical Center
    Lewes, Delaware 19958, United States
  • CCOP - Christiana Care Health Services
    Newark, Delaware 19713, United States
  • MBCCOP - Medical College of Georgia Cancer Center
    Augusta, Georgia 30912, United States
  • Kapiolani Medical Center at Pali Momi
    'Aiea, Hawaii 96701, United States
  • Cancer Research Center of Hawaii
    Honolulu, Hawaii 96813, United States
  • OnCare Hawaii, Incorporated - Lusitana
    Honolulu, Hawaii 96813, United States
  • Queen's Cancer Institute at Queen's Medical Center
    Honolulu, Hawaii 96813, United States
  • Straub Clinic and Hospital, Incorporated
    Honolulu, Hawaii 96813, United States
  • Hawaii Medical Center - East
    Honolulu, Hawaii 96817, United States
  • OnCare Hawaii, Incorporated - Kuakini
    Honolulu, Hawaii 96817, United States
  • Kapiolani Medical Center for Women and Children
    Honolulu, Hawaii 96826, United States
  • Tripler Army Medical Center
    Honolulu, Hawaii 96859, United States
  • Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
    Boise, Idaho 83706, United States
  • Rush-Copley Cancer Care Center
    Aurora, Illinois 60504, United States
  • Louis A. Weiss Memorial Hospital
    Chicago, Illinois 60640, United States
  • Ingalls Cancer Care Center at Ingalls Memorial Hospital
    Harvey, Illinois 60426, United States
  • Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
    Moline, Illinois 61265, United States
  • Moline, Illinois 61265, United States
  • CCOP - Carle Cancer Center
    Urbana, Illinois 61801, United States
  • Elkhart Clinic, LLC
    Elkhart, Indiana 46514-2098, United States
  • Michiana Hematology-Oncology, PC - Elkhart
    Elkhart, Indiana 46514, United States
  • Elkhart General Hospital
    Elkhart, Indiana 46515, United States
  • St. Francis Hospital Cancer Care Services
    Indianapolis, Indiana 46237, United States
  • Howard Community Hospital
    Kokomo, Indiana 46904, United States
  • Michiana Hematology-Oncology, PC - South Bend
    Mishawaka, Indiana 46545-1470, United States
  • Saint Joseph Regional Medical Center
    Mishawaka, Indiana 46545-1470, United States
  • Michiana Hematology Oncology PC - Plymouth
    Plymouth, Indiana 46563, United States
  • Reid Hospital & Health Care Services
    Richmond, Indiana 47374, United States
  • CCOP - Northern Indiana CR Consortium
    South Bend, Indiana 46601, United States
  • Memorial Hospital of South Bend
    South Bend, Indiana 46601, United States
  • Michiana Hematology Oncology PC - La Porte
    Westville, Indiana 46391, United States
  • Bettendorf, Iowa 52722, United States
  • Cedar Rapids Oncology Associates
    Cedar Rapids, Iowa 52403, United States
  • Mercy Regional Cancer Center at Mercy Medical Center
    Cedar Rapids, Iowa 52403, United States
  • Medical Oncology and Hematology Associates - West Des Moines
    Clive, Iowa 50325, United States
  • Mercy Cancer Center - West Lakes
    Clive, Iowa 50325, United States
  • CCOP - Iowa Oncology Research Association
    Des Moines, Iowa 50309, United States
  • John Stoddard Cancer Center at Iowa Methodist Medical Center
    Des Moines, Iowa 50309, United States
  • Medical Oncology and Hematology Associates at John Stoddard Cancer Center
    Des Moines, Iowa 50309, United States
  • Medical Oncology and Hematology Associates at Mercy Cancer Center
    Des Moines, Iowa 50314, United States
  • Mercy Cancer Center at Mercy Medical Center - Des Moines
    Des Moines, Iowa 50314, United States
  • John Stoddard Cancer Center at Iowa Lutheran Hospital
    Des Moines, Iowa 50316, United States
  • Siouxland Hematology-Oncology Associates, LLP
    Sioux City, Iowa 51101, United States
  • Mercy Medical Center - Sioux City
    Sioux City, Iowa 51102, United States
  • St. Luke's Regional Medical Center
    Sioux City, Iowa 51104, United States
  • Methodist West Hospital
    West Des Moines, Iowa 50266-7700, United States
  • Cancer Center of Kansas, PA - Chanute
    Chanute, Kansas 66720, United States
  • Cancer Center of Kansas, PA - Dodge City
    Dodge City, Kansas 67801, United States
  • Cancer Center of Kansas, PA - El Dorado
    El Dorado, Kansas 67042, United States
  • Cancer Center of Kansas - Fort Scott
    Fort Scott, Kansas 66701, United States
  • Cancer Center of Kansas-Independence
    Independence, Kansas 67301, United States
  • Cancer Center of Kansas, PA - Kingman
    Kingman, Kansas 67068, United States
  • Lawrence Memorial Hospital
    Lawrence, Kansas 66044, United States
  • Cancer Center of Kansas, PA - Liberal
    Liberal, Kansas 67901, United States
  • Cancer Center of Kansas, PA - Newton
    Newton, Kansas 67114, United States
  • Cancer Center of Kansas, PA - Parsons
    Parsons, Kansas 67357, United States
  • Cancer Center of Kansas, PA - Pratt
    Pratt, Kansas 67124, United States
  • Cancer Center of Kansas, PA - Salina
    Salina, Kansas 67401, United States
  • Cancer Center of Kansas, PA - Wellington
    Wellington, Kansas 67152, United States
  • Associates in Womens Health, PA - North Review
    Wichita, Kansas 67208, United States
  • Cancer Center of Kansas, PA - Medical Arts Tower
    Wichita, Kansas 67208, United States
  • Cancer Center of Kansas, PA - Wichita
    Wichita, Kansas 67214, United States
  • CCOP - Wichita
    Wichita, Kansas 67214, United States
  • Via Christi Cancer Center at Via Christi Regional Medical Center
    Wichita, Kansas 67214, United States
  • Cancer Center of Kansas, PA - Winfield
    Winfield, Kansas 67156, United States
  • Ochsner Cancer Institute at Ochsner Clinic Foundation
    New Orleans, Louisiana 70121, United States
  • Union Hospital of Cecil County
    Elkton, Maryland 21921, United States
  • Boston University Cancer Research Center
    Boston, Massachusetts 02118, United States
  • Hickman Cancer Center at Bixby Medical Center
    Adrian, Michigan 49221, United States
  • Saint Joseph Mercy Cancer Center
    Ann Arbor, Michigan 48106-0995, United States
  • CCOP - Michigan Cancer Research Consortium
    Ann Arbor, Michigan 48106, United States
  • Oakwood Cancer Center at Oakwood Hospital and Medical Center
    Dearborn, Michigan 48123-2500, United States
  • Genesys Hurley Cancer Institute
    Flint, Michigan 48503, United States
  • Hurley Medical Center
    Flint, Michigan 48503, United States
  • Van Elslander Cancer Center at St. John Hospital and Medical Center
    Grosse Pointe Woods, Michigan 48236, United States
  • Foote Memorial Hospital
    Jackson, Michigan 49201, United States
  • Sparrow Regional Cancer Center
    Lansing, Michigan 48912-1811, United States
  • St. Mary Mercy Hospital
    Livonia, Michigan 48154, United States
  • Community Cancer Center of Monroe
    Monroe, Michigan 48162, United States
  • Mercy Memorial Hospital - Monroe
    Monroe, Michigan 48162, United States
  • St. Joseph Mercy Oakland
    Pontiac, Michigan 48341-2985, United States

Showing the first 100 of 257 sites.

09

References and documents

Publications

  • Miller RC, Petereit DG, Sloan JA, Liu H, Martenson JA, Bearden JD 3rd, Sapiente R, Seeger GR, Mowat RB, Liem B, Iott MJ, Loprinzi CL; Alliance for Clinical Trials in Oncology. N08C9 (Alliance): A Phase 3 Randomized Study of Sulfasalazine Versus Placebo in the Prevention of Acute Diarrhea in Patients Receiving Pelvic Radiation Therapy. Int J Radiat Oncol Biol Phys. 2016 Jul 15;95(4):1168-74. doi: 10.1016/j.ijrobp.2016.01.063. Epub 2016 Apr 23. PubMed 27354129 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 12, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01198145
Lead sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Sep 9, 2010
Start date
Apr 2011
Primary completion
Jul 22, 2013
Completion
Jul 15, 2017
Results posted
Apr 4, 2017
Last update
May 12, 2020

Study contacts

Robert C. Miller, MD
study chair · Mayo Clinic

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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