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Melatonin Supplementation for Cancer-Related Fatigue in Patients With Early Stage Breast Cancer Receiving Radiotherapy: A Double-Blind Placebo-Controlled Trial.
- Source :
- Oncologist; Feb2024, Vol. 29 Issue 2, pe206-e212, 7p
- Publication Year :
- 2024
-
Abstract
- Background Fatigue is common in patients undergoing radiotherapy (RT) and can significantly impact quality of life. Melatonin, a safe inexpensive natural supplement, may improve symptoms and attenuate the side effects of RT. The purpose of this randomized double-blind placebo-controlled phase III trial was to assess the effects of melatonin for preventing fatigue and other symptoms in patients with breast cancer undergoing RT. Methods Female early stage or Ductal carcinoma in situ patients with breast cancer ≥18 years of age with Eastern Cooperative Oncology Group (ECOG) performance status <3, hemoglobin ≥9 g/dL, planned for outpatient RT treatment with curative intent, were randomized 1:1 to melatonin 20 mg or placebo, orally, starting the night before RT initiation until 2 weeks post-RT. Randomization was stratified according to treatment duration (<3 weeks, ≥3 weeks) and prior chemotherapy. The primary endpoint was the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue scale), and secondary endpoints were FACIT-F subscales, Edmonton Symptom Assessment Scale (ESAS), and Patient-Reported Outcomes Measurement Information System (PROMIS) scores obtained at baseline, and 2 and 8 weeks post-RT. A 2-sided ANOVA F -test at a 4.5% significance level for the primary endpoint was used. Secondary analyses were reported using an F -test at a 5% significance level. The goal was to recruit approximately 140 patients with interim analysis planned mid-recruitment. Results Eighty-five patients were screened for eligibility; 79 patients were randomized: 40 to melatonin and 39 to placebo; 78 patients were treated and included in the interim analysis at the mid-recruitment point. Baseline patient characteristics of age, race, and ECOG performance status were similar in both arms. The treatment effect was studied using a longitudinal mixed effects model with the effect of treatment over time (treatment × time) as the primary outcome parameter. The treatment × time for FACIT-Fatigue did not demonstrate statistical significance (P -value.83) in the melatonin group compared to placebo. In addition, secondary analyses of FACIT physical, social, emotional, and functional well-being scores did not demonstrate statistical significance (P -values of.35,.06,.62, and.71, respectively). Total PROMIS scores, collected as secondary outcome reported by patients, did not demonstrate statistically significant change over time either (P -value is.34). The other secondary scale, ESAS, was analyzed for each individual item and found to be nonsignificant, anxiety (P = .56), well-being (.82), drowsiness (.83), lack of appetite (.35), nausea (.79), pain (.50), shortness of breath (.77), sleep (.45), and tiredness (.56). Depression was the only item demonstrating statistical significance with a decrease of 0.01 unit in the placebo group, a change not considered clinically significant. Melatonin was well-tolerated with no grade 3 or 4 adverse events reported. The most common side effects were headache, somnolence, and abdominal pain. No patients died while participating in this study. Two patients died within a year of study completion from breast cancer recurrence. Sixteen patients withdrew prior to study completion for various reasons including adverse events, hospitalizations unrelated to study drug, RT discontinuation, and COVID-19 precautions. Conclusions In this double-blind placebo-controlled phase III trial, melatonin did not prevent or significantly improve fatigue and other symptoms in patients with early stage breast cancer undergoing RT. The analysis, showing little evidence of an effect, at mid-recruitment, assured early termination of the trial. [ABSTRACT FROM AUTHOR]
- Subjects :
- BREAST tumor diagnosis
WELL-being
APPETITE
ANALYSIS of variance
NAUSEA
COVID-19
ORAL drug administration
CANCER chemotherapy
AGE distribution
EARLY detection of cancer
TREATMENT duration
RACE
CANCER relapse
RADIATION
MELATONIN
DIETARY supplements
CANCER patients
TREATMENT effectiveness
RANDOMIZED controlled trials
DUCTAL carcinoma
PLACEBOS
DYSPNEA
SLEEP
HYPERSOMNIA
QUALITY of life
BLIND experiment
RESEARCH funding
MENTAL depression
HOSPITAL care
DESCRIPTIVE statistics
FATIGUE (Physiology)
STATISTICAL sampling
TIME management
ANXIETY
HEADACHE
ABDOMINAL pain
BREAST tumors
SECONDARY analysis
LONGITUDINAL method
Subjects
Details
- Language :
- English
- ISSN :
- 10837159
- Volume :
- 29
- Issue :
- 2
- Database :
- Complementary Index
- Journal :
- Oncologist
- Publication Type :
- Academic Journal
- Accession number :
- 175259560
- Full Text :
- https://doi.org/10.1093/oncolo/oyad250