Naltrexone RCT for Treatment-Emergent Fatigue in Patients Receiving Radiation Therapy for Breast Cancer
Naltrexone is a drug which blocks some effects of chemicals called beta-endorphins that are made in the body. Beta-endorphins can be made in response to stress, injury, and also pleasurable activities. In previous studies, it has been shown that levels of beta-endorphins in the blood go up during radiation therapy, and that this increase is linked to fatigue. This suggests that naltrexone may help to reduce fatigue in people who are getting radiation therapy In this research study, the investigators are looking to see whether naltrexone works better than a placebo in reducing fatigue during radiation therapy.
Study Start Date
Estimated Completion Date
- Drug: Naltrexone
- Drug: Sugar Pill
- Obstetrics & Gynecology: Breast,Clinical Pharmacology
- Oncology: Breast,Pharmacology/Therapy
- Pharmacy: Chemotherapy/Oncology
- Physician Assistant: Clinical Pharmacology,Hematology/Oncology,Obstetrics/Gynecology
- Breast Neoplasms
Dana-Farber Cancer Institute -- 14-056
Dana-Farber Cancer Institute
Exclusion Criteria for Monitoring Phase
- Suicidal ideation, as determined via PHQ-9
- Non-English speaking Exclusion Criteria for Randomization Phase
- Participants with major depressive disorder and/or suicidal ideation as determined by PHQ-9.
- Participants who are receiving any other investigational agents that might interact with study medication or influence the measurement of study outcomes.
- Participants with known metastatic disease should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to naltrexone.
- Participants who have used opioid-containing medications (including cough/cold medications containing codeine and/or antidiarrheals containing loperamide) in the past 2 weeks, or who are expected to require opioid-containing medications within the duration of the treatment period.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant women are excluded from this study because naltrexone is category C agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with naltrexone, breastfeeding should be discontinued if the mother is treated with naltrexone.
- Participants using other contraindicated medications (thioridazine, yohimbine)
18 Years and older
Accepts Healthy Volunteers
Study Locations and Contact Information (2)
|DanaFarber Cancer Institute - Boston, Massachusetts||2.4 miles||Fremonta Meyer MDfirstname.lastname@example.org|
|Massachusetts General Hosptial - Boston, Massachusetts||2.8 miles||Alphonse Taghian MD PhDemail@example.com|