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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by M.D. Anderson Cancer Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01746043
First received: December 6, 2012
Last updated: January 29, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Esophageal Cancer
Drug: Armodafinil
Other: Placebo
Drug: Minocycline
Behavioral: Questionnaires
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Phase II Study of Minocycline and Armodafinil for Reducing the Symptom Burden Produced by Chemoradiation Treatment for Esophageal Cancer

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Mean Symptom Increase During Chemoradiation Therapy [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    Mean symptom score at both time points defined as the mean of the patients MDASI scores for the symptoms of fatigue, drowsiness, sleep disturbance, pain and lack of appetite.


Estimated Enrollment: 80
Study Start Date: February 2013
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
150 mg by mouth once a day for 6 weeks.
Other Name: Nuvigil
Other: Placebo
1 capsule by mouth 2 times a day for 6 weeks.
Other Name: Sugar pill
Behavioral: Questionnaires
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 Name: Surveys
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
1 capsule by mouth 2 times a day for 6 weeks.
Other Name: Sugar pill
Drug: Minocycline
100 mg by mouth 2 times a day for 6 weeks.
Other Names:
  • Dynacin
  • Minocin
  • Minocin PAC
  • Myrac
  • Solodyn
Behavioral: Questionnaires
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 Name: Surveys
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
150 mg by mouth once a day for 6 weeks.
Other Name: Nuvigil
Drug: Minocycline
100 mg by mouth 2 times a day for 6 weeks.
Other Names:
  • Dynacin
  • Minocin
  • Minocin PAC
  • Myrac
  • Solodyn
Behavioral: Questionnaires
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 Name: Surveys
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
1 capsule by mouth 2 times a day for 6 weeks.
Other Name: Sugar pill
Behavioral: Questionnaires
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 Name: Surveys

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01746043

Contacts
Contact: Steven H. Lin, MD, PHD 713-745-3470

Locations
United States, Texas
UT MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Steven H. Lin, MD, PHD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01746043     History of Changes
Other Study ID Numbers: 2012-0117
Study First Received: December 6, 2012
Last Updated: January 29, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Esophageal cancer
Chemotherapy
Radiation therapy
XRT
Chemoradiation
CXRT
Symptom Burden
Armodafinil
Nuvigil
Minocycline
Dynacin
Minocin
Minocin PAC
Myrac
Solodyn
Placebo
Sugar pill
Questionnaires
Surveys

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Minocycline
Modafinil
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Stimulants
Physiological Effects of Drugs
Central Nervous System Agents
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on July 23, 2014