Naltrexone RCT for Treatment-Emergent Fatigue in Patients Receiving Radiation Therapy for Breast Cancer
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|ClinicalTrials.gov Identifier: NCT02137252|
Recruitment Status : Active, not recruiting
First Posted : May 13, 2014
Last Update Posted : February 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Supportive Care|
|Official Title:||Naltrexone Randomized Controlled Trial for Treatment-Emergent Fatigue in Patients Receiving Radiation Therapy for Breast Cancer|
|Study Start Date :||May 2014|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||April 2022|
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|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|