A Phase 3 interventional study of pyridoxine hydrochloride and urea/lactic acid-based topical cream in Breast Cancer, Drug/Agent Toxicity by Tissue/Organ and Unspecified Adult Solid Tumor, Protocol Specific, sponsored by Alliance for Clinical Trials in Oncology. Completed at 231 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-03-16.
Sponsored by Alliance for Clinical Trials in Oncology · Phase 3, Interventional, and Supportive care
RATIONALE: Pyridoxine (vitamin B6) and topical urea/lactic acid-based cream may prevent or lessen hand-foot syndrome caused by chemotherapy. It is not yet known whether giving pyridoxine with or without topical urea/lactic acid-based cream is more effective than topical urea/lactic acid-based cream alone or a placebo in preventing hand-foot syndrome.
PURPOSE: This randomized phase III trial is studying pyridoxine and topical urea/lactic acid-based cream to see how well they work compared with giving pyridoxine together with a placebo, giving topical urea/lactic acid-based cream together with a placebo, or giving two placebos in preventing hand-foot syndrome in patients who are receiving capecitabine for breast cancer or other cancer.
OBJECTIVES:
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to age (\< 50 years old vs 50-60 years old vs > 60 years old), sex, capecitabine dose level (2000 mg/day vs 2500 mg/day), cancer type (breast vs other), and mode of therapy (adjuvant [including neo-adjuvant] therapy vs metastatic disease). Patients are randomized to 1 of 6 treatment arms (treatment arms I-IV closed to accrual as of 10/24/007).
In all arms, treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 137 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
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DISEASE CHARACTERISTICS:
Undergoing first treatment with capecitabine as adjuvant (including neo-adjuvant) therapy OR for metastatic disease
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
No concurrent or planned use of over-the-counter products that contain urea or lactic acid, including any of the following:
Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily and oral pyridoxine once daily on days 1-21.
Dietary Supplement: pyridoxine hydrochloride · Drug: urea/lactic acid-based topical cream
Patients receive topical urea/lactic acid-based cream as in arm I (closed to accrual as of 10/24/2007) and oral placebo once daily on days 1-21.
Drug: urea/lactic acid-based topical cream · Other: placebo
Patients receive placebo cream applied to palms and soles twice daily and pyridoxine as in arm I (closed to accrual as of 10/24/2007).
Dietary Supplement: pyridoxine hydrochloride · Other: placebo
Patients receive placebo cream as in arm III and oral placebo as in arm II (closed to accrual as of 10/24/2007).
Other: placebo
Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily on days 1-21.
Drug: urea/lactic acid-based topical cream
Patients receive placebo cream applied to palms and soles twice daily on days 1-21.
Other: placebo
Given orally
Applied topically
Given orally or applied topically
To Determine Whether the Prophylactic Use of a Topical Urea/Lactic Acid Cream Can Decrease the Incidence/Severity of Capecitabine-caused Palmar-plantar Erythrodysesthesia
A patient self-reported hand-foot syndrome (HFSD), also known as palmar-plantar erythrodysesthesia, was completed daily while applying the cream. Patients rated skin severity symptoms individually in their hands and in their feet. Definitions of symptoms, which were based on Common Terminology Criteria for Adverse Events (CTCAE) v3.0, were provided to patients. The number of patients reporting moderate to severe symptoms in either hands or feet were tabulated and percentages are reported.
Time frame: First 3 weeks of treatment
To Evaluate the Potential Toxicity of Urea/Lactic Acid Cream
Frequency and severity of adverse events reported by patients in weekly diary and evaluated through clinical assessment by NCI CTCAE v3.0. The number of patients reporting grade 3 or higher events are reported in this outcome measure. For a full list of all events, please refer to the Adverse Events section of this report.
Time frame: Up to 4, 21-day cycles
Determine Whether the Prophylactic Use of Vitamin B6 Can Decrease the Incidence and/or Severity of Capecitabine-caused Palmar-plantar Erythrodysesthesia (HFSD).
A patient self-reported hand-foot syndrome diary (HFSD) was completed daily while applying the cream. Patients rated skin severity symptoms individually in their hands and in their feet. Definitions of symptoms, which were based on Common Terminology Criteria for Adverse Events (CTCAE) v3.0, were provided to patients. The number of patients reporting moderate to severe symptoms were tabulated and percentages are reported.
Time frame: First 3 weeks of treatment
Evaluate the Potential Toxicity of Vitamin B6.
Frequency and severity of adverse events reported by patients in weekly diary and evaluated through clinical assessment by NCI CTCAE v3.0. The number of patients reporting grade 3 or higher events are reported in this outcome measure. For a full list of all events, please refer to the Adverse Events section of this report.
Time frame: up to 4, 21-day cycles
Determine Whether the Prophylactic Use of a Topical Urea/Lactic Acid Cream in Combination With Vitamin B6 Can Decrease the Incidence and/or Severity of Capecitabine Caused Palmar-plantar Erythrodysesthesia.
A patient self-reported hand-foot syndrome diary (HFSD) was completed daily while applying the cream. Patients rated skin severity symptoms individually in their hands and in their feet. Definitions of symptoms, which were based on Common Terminology Criteria for Adverse Events (CTCAE) v3.0, were provided to patients. The number of patients reporting moderate to severe symptoms were tabulated.
Time frame: First 3 weeks of treatment
| Milestone | Arm I: (Urea/Lactic Acid +Vit B6) | Arm II: (Urea/Lactic Acid + Placebo) | Arm III: (Placebo +Vit B6) | Arm IV: (Placebo + Placebo) | Arm V: Urea/Lactic Acid | Arm VI: (Placebo) |
|---|---|---|---|---|---|---|
| Started | 19 | 18 | 18 | 17 | 33 | 32 |
| Completed | 18 | 18 | 16 | 16 | 31 | 28 |
| Not completed | 1 | 0 | 2 | 1 | 2 | 4 |
| Withdrew: Withdrawal by subject | 1 | 0 | 2 | 1 | 2 | 1 |
| Withdrew: Protocol violation | 0 | 0 | 0 | 0 | 0 | 3 |
A patient self-reported hand-foot syndrome (HFSD), also known as palmar-plantar erythrodysesthesia, was completed daily while applying the cream. Patients rated skin severity symptoms individually in their hands and in their feet. Definitions of symptoms, which were based on Common Terminology Criteria for Adverse Events (CTCAE) v3.0, were provided to patients. The number of patients reporting moderate to severe symptoms in either hands or feet were tabulated and percentages are reported.
| percentage of participants | Urea/Lactic Acid Cream | Placebo Cream |
|---|---|---|
| To Determine Whether the Prophylactic Use of a Topical Urea/Lactic Acid Cream Can Decrease the Incidence/Severity of Capecitabine-caused Palmar-plantar Erythrodysesthesia | 13.6 | 10.2 |
Frequency and severity of adverse events reported by patients in weekly diary and evaluated through clinical assessment by NCI CTCAE v3.0. The number of patients reporting grade 3 or higher events are reported in this outcome measure. For a full list of all events, please refer to the Adverse Events section of this report.
| participants | Urea/Lactic Acid Cream | Placebo Cream |
|---|---|---|
| Grade 3+ Adverse Event | 21 | 18 |
| Grade 4+ Adverse Event | 3 | 3 |
A patient self-reported hand-foot syndrome diary (HFSD) was completed daily while applying the cream. Patients rated skin severity symptoms individually in their hands and in their feet. Definitions of symptoms, which were based on Common Terminology Criteria for Adverse Events (CTCAE) v3.0, were provided to patients. The number of patients reporting moderate to severe symptoms were tabulated and percentages are reported.
No measurements were reported for this outcome.
Frequency and severity of adverse events reported by patients in weekly diary and evaluated through clinical assessment by NCI CTCAE v3.0. The number of patients reporting grade 3 or higher events are reported in this outcome measure. For a full list of all events, please refer to the Adverse Events section of this report.
No measurements were reported for this outcome.
A patient self-reported hand-foot syndrome diary (HFSD) was completed daily while applying the cream. Patients rated skin severity symptoms individually in their hands and in their feet. Definitions of symptoms, which were based on Common Terminology Criteria for Adverse Events (CTCAE) v3.0, were provided to patients. The number of patients reporting moderate to severe symptoms were tabulated.
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Urea/Lactic Acid Cream | — | 0/67 (0%) | 56/67 (83.6%) |
| Placebo Cream | — | 0/63 (0%) | 50/63 (79.4%) |
| Event | Urea/Lactic Acid Cream | Placebo Cream |
|---|---|---|
| Hand-and-foot syndromeSkin and subcutaneous tissue disorders | 43/67 | 34/63 |
| DiarrheaGastrointestinal disorders | 26/67 | 27/63 |
| DehydrationMetabolism and nutrition disorders | 6/67 | 5/63 |
| FatigueGeneral disorders | 4/67 | 5/63 |
| VomitingGastrointestinal disorders | 1/67 | 4/63 |
| NauseaGastrointestinal disorders | 4/67 | 2/63 |
| Mucositis oralGastrointestinal disorders | 1/67 | 3/63 |
| Abdominal distensionGastrointestinal disorders | 0/67 | 2/63 |
| AscitesGastrointestinal disorders | 0/67 | 2/63 |
| Aspartate aminotransferase increasedInvestigations | 0/67 | 2/63 |
Arms I (18), II (18), and IV (31) were combined and analyzed as patients treated with Urea/Lactic Acid Cream. Arms III (16), IV (16), and VI (28) were combined as patients treated with placebo in place of Urea/Lactic Acid Cream.
| Age, Customized(participants) | Urea/Lactic Acid Cream | Placebo Cream | Total |
|---|---|---|---|
| <50 | 11 | 9 | 20 |
| 50-60 | 19 | 17 | 36 |
| > 60 | 37 | 34 | 71 |
| Sex: Female, Male(Participants) | Urea/Lactic Acid Cream | Placebo Cream | Total |
|---|---|---|---|
| Female | 52 | 49 | 101 |
| Male | 15 | 11 | 26 |
| Region of Enrollment(participants) | Urea/Lactic Acid Cream | Placebo Cream | Total |
|---|---|---|---|
| United States | 67 | 60 | 127 |
Showing the first 100 of 231 sites.
This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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Alliance for Clinical Trials in Oncology