Ductal Carcinoma in Situ, Fatigue Related to Cancer Treatment, Invasive Breast Cancer (Stage I-III), Lobular Carcinoma, Lobular Carcinoma in Situ
Conditions
Keywords
Invasive Breast Cancer (Stage I-III), Ductal Carcinoma in Situ, Lobular Carcinoma in Situ, Lobular Carcinoma, Fatigue Related to Cancer Treatment
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.
Detailed description
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.
Interventions
DRUGNaltrexone
DRUGSugar Pill
Sponsors
National Cancer Institute (NCI)
Dana-Farber Cancer Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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 * Receiving radiation therapy of any type at DFCI, BWH, or MGH (including but not limited to partial breast irradiation, two-field, three-field, and four-field plans) * FACIT-F subscale score \>=10 pre-radiation therapy and decrease in FACIT-F of 10 points or more as compared to pre-radiotherapy baseline
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in FACIT-fatigue Subscale Score From Randomization to End of Study | Evaluated at baseline, weekly monitoring visits from start of radiation therapy and meets fatigue eligibility threshold | 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. |
Countries
United States
Participant flow
Pre-assignment details
In the monitoring phase, eligibility for randomization was defined as FACIT-F subscale score \>=10 pre-radiation therapy and decrease in FACIT-F of 10 points.
Participants by arm
| Arm | Count |
|---|---|
| Naltrexone 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. | 2 |
| Placebo: Sugar Pill daily dose placebo for 5 week treatment period | 1 |
| Total | 3 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | trial terminated early | 2 | 1 |
Baseline characteristics
| Characteristic | Placebo: Sugar Pill | Total | Naltrexone |
|---|---|---|---|
| Age, Continuous | 59 Years | 52.3 Years | 49 Years |
| Race/Ethnicity, Customized White | 1 Participants | 3 Participants | 2 Participants |
| Region of Enrollment United States | 1 participants | 3 participants | 2 participants |
| Sex: Female, Male Female | 1 Participants | 3 Participants | 2 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 1 |
| other Total, other adverse events | 2 / 2 | 1 / 1 |
| serious Total, serious adverse events | 0 / 2 | 0 / 1 |
Outcome results
Primary
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.
Time frame: Evaluated at baseline, weekly monitoring visits from start of radiation therapy and meets fatigue eligibility threshold
Population: trial terminated early