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

NCT01746043 | Completed Phase 2 Results DMC

• 3 other identifiers: 2012-0117NCI-2013-00584R01CA026582
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

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

  Baseline, 6 weeks

Study Arms (4)

Armodafinil + Placebo

EXPERIMENTAL

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

Minocycline + Placebo

EXPERIMENTAL

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

Armodafinil + Minocycline

EXPERIMENTAL

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

Placebos

PLACEBO COMPARATOR

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

Armodafinil DRUG

150 mg by mouth once a day for 6 weeks.

Also known as: Nuvigil

Armodafinil + Minocycline; Armodafinil + Placebo

Placebo OTHER

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

Also known as: Sugar pill

Armodafinil + Placebo; Minocycline + Placebo; Placebos

Minocycline DRUG

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

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

Armodafinil + Minocycline; Minocycline + Placebo

Questionnaires BEHAVIORAL

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

Armodafinil + Minocycline; Armodafinil + Placebo; Minocycline + Placebo; Placebos

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a pathologically proven diagnosis of esophageal cancer
• Patients \> or = 18 years old
• Patients who will receive chemotherapy and radiation therapy
• Patients who speak English or Spanish
• Patients must be willing and able to review, understand, and provide written consent before starting therapy
• Patients must agree to discontinue St John's Wort herbal supplement use, and refrain from taking it while on protocol
• 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
• Sexually active males and females must agree to use effective birth control or to be abstinent for the duration of the study period
• 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.

You may not qualify if:

• Patients who are enrolled in other symptom management clinical trials
• Patients currently taking methylphenidate and/or dextroamphetamine
• 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
• Patients with pre-existing psychosis or bipolar disorder
• 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.
• 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.
• Patients with pre-existing Tourette's syndrome
• Patients with hypersensitivity to any tetracyclines
• Patients with uncontrolled cardiac disease, including angina and cardiac ischemia, left ventricular hypertrophy, myocardial infarction, and mitral valve prolapse.
• 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).
• Patients on vitamin K antagonist warfarin

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Esophageal Neoplasms; cyclopia sequence

Interventions

Modafinil; Sugars; Minocycline; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Carbohydrates; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: Lin,Steven H,M.D. Ph.D. / Radiation Oncology
• Organization: UT MD Anderson Cancer Center

CR_Study_Registration@mdanderson.org

713-792-7734

Study Officials

• Steven H. Lin, MD, PHD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2012
• First Posted: December 10, 2012
• Study Start: February 1, 2013
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: June 6, 2018
• Results First Posted: June 6, 2018

Record last verified: 2018-05

Locations

US (1)