Naltrexone Hydrochloride in Reducing Radiation Therapy Related Fatigue in Patients with Breast Cancer

Inclusion Criteria

• MONITORING PHASE:
• Diagnosis of: invasive breast cancer (stage I-III), ductal carcinoma in situ, lobular carcinoma in situ, lobular carcinoma
• Plan to receive radiation therapy, or within 3 days of starting radiation therapy
• RANDOMIZATION PHASE:
• Participants may have had prior breast surgery and/or chemotherapy
• Total bilirubin within normal institutional limits
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 × institutional upper limit of normal
• Creatinine within normal institutional limits OR creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
• Thyroid stimulating hormone (TSH) < 10 mIU/L
• If child-bearing potential, willingness to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
• Ability to understand and the willingness to sign a written informed consent document
• Receiving radiation therapy of any type at Dana-Farber Cancer Institute (DFCI), Brigham and Women's Hospital (BWH), Massachusetts General Hospital (MGH), or affiliated network sites (including but not limited to partial breast irradiation, two-field, three-field, and four-field plans)
• Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-F) subscale score >= 10 pre-radiation therapy and decrease in FACIT-F of 10 points or more as compared to prior FACIT

Exclusion Criteria

• Monitoring phase:
• Suicidal ideation, as determined via Patient Health Questionnaire (PHQ)-9
• Non-English speaking
• 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
• 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; breastfeeding should be discontinued if the mother is treated with naltrexone
• Participants using other contraindicated medications (thioridazine, yohimbine)