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CompletedNCT01746043Updated Jun 6, 2018Results posted

A Phase II Study of Minocycline and Armodafinil for Reducing the Symptom Burden Produced by Chemoradiation Treatment for Esophageal Cancer

A Phase 2 interventional study of Armodafinil and Placebo in Esophageal Cancer, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-06-06.

Sponsored by M.D. Anderson Cancer Center · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
22
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The goal of this clinical research study is to compare armodafinil and minocycline when given alone or in combination to learn which is better for controlling side effects of chemoradiation treatment for esophageal cancer (such as fatigue, pain, disturbed sleep, lack of appetite, and drowsiness).

Armodafinil is designed to prevent excessive sleepiness.

Minocycline is an antibiotic, which may help to reduce multiple symptoms.

In this study, you may receive a placebo. A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.

Read the detailed description

Study Groups:

If you are eligible to take part in this study, you will be randomly assigned (as in the roll of dice) to join 1 of 4 groups. You will have an equal chance of being in any group.

  • Group 1 will take armodafinil and a placebo.
  • Group 2 will take minocycline and a placebo.
  • Group 3 will take armodafinil and minocycline.
  • Group 4 will take 2 placebos.

Neither you nor the study staff you will see in the clinic will know if you are receiving the study drug(s) and/or the placebo(s). However, if needed for your safety, the study staff will be able to find out which study drug you are receiving.

If needed, you will be given standard drugs to help decrease the risk of side effects. You may ask the study staff for information about how the drugs are given and their risks.

Study Drug/Placebo Administration:

You will take the study drug/placebo 2 times a day for 6 weeks. You should take the capsules with a full glass of water. If you get an upset stomach, take them with food.

You will be given pamphlets with more information about how to take the study capsules.

You should bring your study capsules to every study visit.

Completing the Symptom Questionnaire:

Throughout the study, you will be asked to complete a questionnaire about your symptoms. This questionnaire will ask about symptoms from therapy you may be having and how they may be interfering with your daily activities. The study staff will either meet you during your regular clinic visit or call you at your home at a time that is convenient for you. In the clinic, you will complete the questionnaire by paper and pen, or by entering your answers into an electronic tablet computer. On the phone, a study staff member will ask you the questions and record your answers. You will complete the symptom questionnaire before you begin chemoradiation and then 1 time a week for the rest of the study. The symptom questionnaire will take up to 5 minutes to complete.

Study Visits:

Before you begin chemoradiation:

  • You will complete questionnaires about pain and other symptoms, your mood, and your quality of life. Completing all 5 questionnaires will take about 15 minutes.
  • If you can become pregnant and you did not have a pregnancy test during screening, you will have a urine pregnancy test. The study staff will give you the urine pregnancy test kit at your scheduled visit, and will review the results before you pick up the study capsules from the pharmacy.

About Week 3 or 4, you will be asked to complete a questionnaire that asks you about your satisfaction with the study capsules. This will take a few minutes.

During the last week of chemoradiation (about Week 5 or 6):

  • You will complete 3 questionnaires about your symptoms, mood, and quality of life. These questionnaires will take about 10 minutes total to complete.
  • You will also be asked to complete a questionnaire that asks about your satisfaction with the study capsules. This will take a few minutes.

After about Week 5 or 6, the study staff will call you 1 time a week to check on you until the study ends. This phone call should last only a few minutes. If you have had several side effects from chemoradiation, this phone call may take longer.

At your first routine clinical follow-up visit (about Week 10 to 14):

  • You will complete the 3 questionnaires about your symptoms, mood, and quality of life.
  • You will also be asked to complete another questionnaire that asks about your satisfaction with the study capsules.

Length of Study:

You will be on study for about 10-14 weeks. You will take the study drug(s) for 6 weeks and complete the symptom survey until the end of the study. You will be taken off study early if you have intolerable side effects.

This is an investigational study. Armodafinil is FDA approved and commercially available for the treatment of sleepiness. Minocycline is FDA approved and commercially available for the treatment of bacterial infections. The use of these drugs to help reduce chemoradiation symptoms is investigational.

Up to 80 patients will take part in this study. All will be enrolled at MD Anderson.

02

Conditions studied

  • Esophageal Cancer

Keywords

  • Esophageal cancer
  • Chemotherapy
  • Radiation therapy
  • XRT
  • Chemoradiation
  • CXRT
  • Symptom Burden
  • Armodafinil
  • Nuvigil
  • Minocycline
  • Dynacin
  • Minocin
  • Minocin PAC
  • Myrac
  • Solodyn
  • Placebo
  • Sugar pill
  • Questionnaires
  • Surveys
03

In context

Esophageal Neoplasms

1,593 studies on the registry are indexed under Esophageal Neoplasms; 461 are open to participants now.

This study's enrollment of 22 is below the median of 58 across 1,171 interventional studies indexed under Esophageal Neoplasms.

Browse Esophageal Neoplasms studies →

Lead sponsor

M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.

Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) 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

Inclusion criteria

  1. Patients with a pathologically proven diagnosis of esophageal cancer
  2. Patients > or = 18 years old
  3. Patients who will receive chemotherapy and radiation therapy
  4. Patients who speak English or Spanish
  5. Patients must be willing and able to review, understand, and provide written consent before starting therapy
  6. Patients must agree to discontinue St John's Wort herbal supplement use, and refrain from taking it while on protocol
  7. Women of childbearing potential (women who are not postmenopausal for at least 1 year and are not surgically sterile) must have a negative urine pregnancy test
  8. Sexually active males and females must agree to use effective birth control or to be abstinent for the duration of the study period
  9. Women currently taking birth control pills or planning to start birth control pills must agree to an additional method of birth control (either abstinence or a barrier method) while on the study medication and for 1 additional month after study completion.

Exclusion criteria

Exclusion Criteria:

  1. Patients who are enrolled in other symptom management clinical trials
  2. Patients currently taking methylphenidate and/or dextroamphetamine
  3. Patients with a history of clinically significant cutaneous drug reaction, or a history of clinically significant hypersensitivity reaction, as documented in the patient medical records
  4. Patients with pre-existing psychosis or bipolar disorder
  5. Patients with pre-existing renal impairment: The screening cut off for serum creatinine >1.5 times the upper limit of normal, within the past 30 days, will be done by the oncologist to qualify for CXRT.
  6. Patients with pre-existing hepatic impairment: The screening for total bilirubin >25.7 µmol/L (1.5 mg/dL) will be done by the oncologist to qualify for CXRT. The screening for > 2 times the upper limit of normal hepatotoxicity, alkaline phosphatase (ALP), and alanine aminotransferase (ALT) or aspartate aminotransferase (AST) will be done by the oncologist to qualify for CXRT.
  7. Patients with pre-existing Tourette's syndrome
  8. Patients with hypersensitivity to any tetracyclines
  9. Patients with uncontrolled cardiac disease, including angina and cardiac ischemia, left ventricular hypertrophy, myocardial infarction, and mitral valve prolapse.
  10. Patients taking medicines that are strong CYP3A4 inhibitors or inducers (including conivaptan, indinavir, nelfinavir, ritonavir, nefazodone, and phenetoin), or strong CYP2C19 inhibitors (including citalopram and clopidogrel).
  11. Patients on vitamin K antagonist warfarin
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
22 participants (actual)

Study arms

  • Experimental
    Armodafinil + Placebo

    Armodafinil 150 mg by mouth once a day for 6 weeks. Placebo 1 capsule by mouth 2 times a day for 6 weeks. Intervention agents start the day of CXRT, or within 5 days of the start CXRT, and continue for a total of 6 weeks. Completion of symptom questionnaires before chemoradiation and then 1 time a week during Weeks 1-10 of the study. Questionnaire take up to 5 minutes to complete.

    Drug: Armodafinil · Other: Placebo · Behavioral: Questionnaires

  • Experimental
    Minocycline + Placebo

    Minocycline 100 mg by mouth 2 times a day for 6 weeks. Placebo 1 capsule by mouth 2 times a day for 6 weeks. Intervention agents start the day of CXRT, or within 5 days of the start CXRT, and continue for a total of 6 weeks. Completion of symptom questionnaires before chemoradiation and then 1 time a week during Weeks 1-10 of the study. Questionnaire take up to 5 minutes to complete.

    Other: Placebo · Drug: Minocycline · Behavioral: Questionnaires

  • Experimental
    Armodafinil + Minocycline

    Armodafinil 150 mg by mouth once a day for 6 weeks. Minocycline 100 mg by mouth 2 times a day for 6 weeks.Intervention agents start the day of CXRT, or within 5 days of the start CXRT, and continue for a total of 6 weeks. Completion of symptom questionnaires before chemoradiation and then 1 time a week during Weeks 1-10 of the study. Questionnaire take up to 5 minutes to complete.

    Drug: Armodafinil · Drug: Minocycline · Behavioral: Questionnaires

  • Placebo comparator
    Placebos

    Placebo 1 capsule by mouth 2 times a day for 6 weeks. Intervention agents start the day of CXRT, or within 5 days of the start CXRT, and continue for a total of 6 weeks. Completion of symptom questionnaires before chemoradiation and then 1 time a week during Weeks 1-10 of the study. Questionnaire take up to 5 minutes to complete.

    Other: Placebo · Behavioral: Questionnaires

Interventions

  • DrugArmodafinil

    150 mg by mouth once a day for 6 weeks.

    Also known as: Nuvigil

  • OtherPlacebo

    1 capsule by mouth 2 times a day for 6 weeks.

    Also known as: Sugar pill

  • DrugMinocycline

    100 mg by mouth 2 times a day for 6 weeks.

    Also known as: Dynacin, Minocin, Minocin PAC, Myrac, Solodyn

  • BehavioralQuestionnaires

    Completion of symptom questionnaires before chemoradiation and then 1 time a week during Weeks 1-10 of the study. Questionnaire take up to 5 minutes to complete.

    Also known as: Surveys

06

What researchers measure

Primary outcomes

  1. Proportion of Patients Under Each Treatment Arm Who Experienced a Mean Symptom Increase of 2 Units or More From Baseline to 6 Weeks.

    Mean symptom score defined as the mean of MDASI fatigue, pain, disturbed sleep, lack of appetite, and drowsiness scores

    Time frame: Baseline, 6 weeks

07

Results

Posted Jun 6, 2018

Participant flow

Recruitment period: February 25, 2013 to January 5, 2017. All recruitment done at The University of Texas MD Anderson Cancer Center.

Participant flow — Overall Study
MilestoneArmodafinil + PlaceboMinocycline + PlaceboArmodafinil + MinocyclinePlacebo
Started5455
Completed5455
Not completed0000

Outcome measures

PrimaryProportion of Patients Under Each Treatment Arm Who Experienced a Mean Symptom Increase of 2 Units or More From Baseline to 6 Weeks.

Mean symptom score defined as the mean of MDASI fatigue, pain, disturbed sleep, lack of appetite, and drowsiness scores

Time frame:
Baseline, 6 weeks
Reported as:
Count of participants · Participants
Proportion of Patients Under Each Treatment Arm Who Experienced a Mean Symptom Increase of 2 Units or More From Baseline to 6 Weeks.
ParticipantsArmodafinil + PlaceboMinocycline + PlaceboArmodafinil + MinocyclinePlacebos
Proportion of Patients Under Each Treatment Arm Who Experienced a Mean Symptom Increase of 2 Units or More From Baseline to 6 Weeks.0212

Adverse events

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

Adverse event summary by group
GroupDeathsSeriousOther
Armodafinil0/5 (0%)1/5 (20%)0/5 (0%)
Minocycline0/4 (0%)1/4 (25%)0/4 (0%)
Armodafinil+Minocycline0/5 (0%)1/5 (20%)0/5 (0%)
Placebo0/5 (0%)1/5 (20%)0/5 (0%)
Most frequent serious events
Most frequent serious events
EventArmodafinilMinocyclineArmodafinil+MinocyclinePlacebo
FeverGeneral disorders0/51/40/50/5
FatigueGeneral disorders1/50/40/50/5
DysphagiaGastrointestinal disorders1/50/40/50/5
Peripheral NeuropathyNervous system disorders0/50/41/50/5
HeadacheNervous system disorders0/50/40/51/5

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Armodafinil + PlaceboMinocycline + PlaceboArmodafinil + MinocyclinePlaceboTotal
<=18 years00000
Between 18 and 65 years222511
>=65 years32308
Age, Continuous
Age, Continuous(years)Armodafinil + PlaceboMinocycline + PlaceboArmodafinil + MinocyclinePlaceboTotal
Mean63.4 ± 4.664.5 ± 0.661.6 ± 10.256.2 ± 4.961.4 ± 5.1
Sex: Female, Male
Sex: Female, Male(Participants)Armodafinil + PlaceboMinocycline + PlaceboArmodafinil + MinocyclinePlaceboTotal
Female20204
Male343515
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Armodafinil + PlaceboMinocycline + PlaceboArmodafinil + MinocyclinePlaceboTotal
Hispanic or Latino00000
Not Hispanic or Latino545519
Unknown or Not Reported00000
Region of Enrollment
Region of Enrollment(Participants)Armodafinil + PlaceboMinocycline + PlaceboArmodafinil + MinocyclinePlaceboTotal
United States545519
08

Study locations

1 site
  • University of Texas MD Anderson Cancer Center
    Houston, Texas 77030, United States
09

References and documents

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 6, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01746043
Lead sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Dec 10, 2012
Start date
Feb 2013
Primary completion
Jan 2017
Completion
Jan 2017
Results posted
Jun 6, 2018
Last update
Jun 6, 2018

Study contacts

Steven H. Lin, MD, PHD
principal investigator · M.D. Anderson Cancer Center

Oversight

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

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