Study Stopped
no enough patients
Naltrexone RCT for Treatment-Emergent Fatigue in Patients Receiving Radiation Therapy for Breast Cancer
Naltrexone Randomized Controlled Trial for Treatment-Emergent Fatigue in Patients Receiving Radiation Therapy for Breast Cancer
2 other identifiers
interventional
3
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started May 2014
Shorter than P25 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 10, 2014
CompletedFirst Posted
Study publicly available on registry
May 13, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedResults Posted
Study results publicly available
November 16, 2021
CompletedNovember 16, 2021
November 1, 2021
1.3 years
May 10, 2014
October 1, 2021
November 12, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in FACIT-fatigue Subscale Score From Randomization to End of Study
Functional Assessment of Chronic Illness Therapy-Fatigue Subscale (FACIT-fatigue subscale): This 13-item self-report scale measuring fatigue and functional impairment as a result of fatigue has been validated in cancer patients (Cella et al. Cancer 2002;94:528-38) The scale is reverse-scored and the range is 0 (maximum fatigue) - 52 (minimum fatigue). According to ICD10 criteria, a score \<= 34 indicates significant cancer related fatigue. A change of 10 points has been shown to constitute a clinically meaningful difference on this subscale.
Evaluated at baseline, weekly monitoring visits from start of radiation therapy and meets fatigue eligibility threshold
Study Arms (2)
Naltrexone
EXPERIMENTALThe treatment schedule includes a daily dose of naltrexone for 5 weeks. Treatment will be initiated at 25 mg/day during the first week to improve tolerability. The dose will be escalated to 50 mg/day 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.
Sugar Pill
PLACEBO COMPARATORThe treatment schedule includes a daily dose of equivalent placebo for 5 weeks. Treatment will be initiated at 25 mg/day during the first week to improve tolerability. The dose will be escalated to 50 mg/day 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.
Interventions
Eligibility Criteria
You may qualify if:
- Eligibility Criteria for Monitoring Phase
- Age ≥ 18
- Diagnosis of: invasive breast cancer (stage I-III), ductal carcinoma in situ, lobular carcinoma in situ, lobular carcinoma
- Plan to receive radiation therapy
- Eligibility Criteria for Randomization Phase
- Participants may have had prior breast surgery and/or chemotherapy.
- Age ≥18 years.
- Because no dosing or adverse event data are currently available on the use of naltrexone in cancer patients \<18 years of age, children are excluded from this study, but will be eligible for future pediatric trials.
- Participants must have acceptable pre-treatment laboratory values as defined below:
- total bilirubin within normal institutional limits
- AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal
- creatinine within normal institutional limits OR
- creatinine clearance ≥60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.
- 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
- +2 more criteria
You may not qualify if:
- Suicidal ideation, as determined via PHQ-9
- Non-English speaking
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dana-Farber Cancer Institutelead
- National Cancer Institute (NCI)collaborator
Study Sites (2)
Massachusetts General Hosptial
Boston, Massachusetts, 02114, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Fremonta Meyer, MD
- Organization
- Dana-Farber Cancer Institute/Brigham and Women's Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Fremonta Meyer, MD
Dana-Farber Cancer Institute
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 10, 2014
First Posted
May 13, 2014
Study Start
May 1, 2014
Primary Completion
August 1, 2015
Study Completion
August 1, 2015
Last Updated
November 16, 2021
Results First Posted
November 16, 2021
Record last verified: 2021-11
Data Sharing
- IPD Sharing
- Will not share