Naltrexone RCT for Treatment-Emergent Fatigue in Patients Receiving Radiation Therapy for Breast Cancer
|Invasive Breast Cancer (Stage I-III) Ductal Carcinoma in Situ Lobular Carcinoma in Situ Lobular Carcinoma Fatigue Related to Cancer Treatment||Drug: Naltrexone Drug: Sugar Pill||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Supportive Care
|Official Title:||Naltrexone Randomized Controlled Trial for Treatment-Emergent Fatigue in Patients Receiving Radiation Therapy for Breast Cancer|
- Change in FACIT-fatigue subscale score from randomization to end of study [ Time Frame: baseline, week 5 ]
- Changes in sleep continuity (sleep efficiency, total sleep time, sleep latency) from randomization to end of study [ Time Frame: baseline, week 5 ]Pittsburgh Sleep Quality Index, Insomnia Severity Index
- Changes in quality of life measures from randomization to end of study [ Time Frame: baseline, week 5 ]Functional Assessment of Cancer Therapy-Breast Subscale Functional Assessment of Cancer Therapy-Endocrine Symptoms Subscale
- Change in depression from randomization to end of study [ Time Frame: baseline, week 5 ]Patient Health Questionnaire-9
- Change in anxiety from randomization to end of study [ Time Frame: baseline, week 5 ]Generalized Anxiety Disorder-7
|Study Start Date:||May 2014|
|Estimated Study Completion Date:||April 2022|
|Estimated Primary Completion Date:||August 2018 (Final data collection date for primary outcome measure)|
The treatment schedule includes a daily dose of double-blinded naltrexone vs. placebo for 5 weeks. Treatment will be initiated at 25 mg/day (or equivalent placebo) during the first week to improve tolerability. The dose will be escalated to 50 mg/day (or equivalent placebo) after one week barring significant early improvement in fatigue or adverse events precluding dose escalation, and participants will continue to take 50 mg/day (or 25 mg/day if dose is not escalated) for 4 weeks to complete a 5-week treatment period.
Other Name: •ReVia®
No Intervention: Monitoring Phase
Brief self-report questionnaire (Functional Assessment of Chronic Illness Therapy-Fatigue Subscale; FACIT-F)
Placebo Comparator: Sugar Pill
daily dose placebo for 5 week treatment period
|Drug: Sugar Pill|
This trial has two phases (a monitoring and an intervention phase).
Monitoring Phase: Prior to starting radiotherapy for non-metastatic breast cancer, participants will be approached and consented for the monitoring phase of the study, which involves longitudinal monitoring of fatigue in order to establish whether a patient develops fatigue after starting radiation. The level of pre-radiotherapy fatigue will be obtained during the final two weeks before radiotherapy is started. All participants will undergo weekly monitoring of fatigue via a brief self-report questionnaire. The monitoring period will continue up until one month after the conclusion of radiotherapy. Those whose fatigue symptoms increase above the pre-specified threshold at any point during the monitoring period will be approached about enrollment into the intervention phase of the study.
Intervention Phase: This is a randomized, double-blind, parallel-arm 5-week clinical trial which will be used to determine the effect of naltrexone on fatigue emerging during radiation therapy for non-metastatic breast cancer.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02137252
|United States, Massachusetts|
|Massachusetts General Hosptial|
|Boston, Massachusetts, United States, 02114|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Fremonta Meyer, MD||Dana-Farber Cancer Institute|