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Melatonin for Cancer-related Fatigue in Breast Cancer Radiotherapy
NCT02332928Phase 3
Key facts
- Status
- Terminated
- Start
- Mar 2015
- Primary completion
- Jun 2021
- Countries
- 1
- Sponsor
- Virginia Commonwealth University
- Modality
- Small Molecules
- Drugs
- melatonin
- Conditions
- cancer-related fatigue (CRF)
01
Overview
Phase 3, randomised, double-blind trial in cancer-related fatigue (CRF) comparing 20 mg Melatonin with Placebo (2 arms). Primary endpoint: Functional Assessment of Chronic Illness Therapy-Fatigue Subscale. Started Mar 2015; status: terminated.
02
Design
2 arms- Study design
- RandomizedDouble-blind
20 mg Melatonin
20 mg oral melatonin nightly
Placebo
20 mg oral placebo nightly
03
Who it enrols
Women >= 18 years with breast cancer (including DCIS) planned for curative radiotherapy, ECOG < 3, and adequate organ function. Patients taking melatonin must washout for 5 days.
04
Endpoints
Primary
Functional Assessment of Chronic Illness Therapy-Fatigue Subscale
Secondary
Functional Assessment of Chronic Illness Therapy-Fatigue
Edmonton Symptom Assessment System
Patient Reported Outcomes Measurement Information System Fatigue-Short Form 8a
Hospital Admissions, Emergency Center Visits, and Medical Days Off Work
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