Clinical trial · Interventional
Melatonin Supplementation for Cancer-related Fatigue in Patients Receiving Radiotherapy
Melatonin Supplementation for Cancer-related Fatigue in Patients Receiving Radiotherapy: A Double Blind Placebo-Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of efficacy
Summary
Brief summary (as posted)
This is a double-blind, placebo-controlled trial wherein subjects with breast cancer will be randomized to receive either 20 mg oral melatonin or placebo the night before their first radiotherapy (RT), nightly throughout their RT, and for an additional 2 weeks following the completion of their RT. After informed consent is obtained from eligible subjects, they will then be electronically randomized on a 1:1 ratio to melatonin treatment or placebo. The subjects will be stratified according to treatment duration (less than 3 weeks; equal to or greater than 3 weeks) and prior chemotherapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer - Female | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Melatonin | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 20 mg Melatonin
- description
- RT (as clinically indicated) + melatonin (Subjects will receive 20-mg oral melatonin the night before their first RT treatment, each night throughout the course of RT treatment, and for 2 weeks following the completion of RT).
- interventionNames
- Drug: Melatonin
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- RT (as clinically indicated) + placebo (Subjects will receive 20-mg oral placebo the night before their first RT treatment, each night throughout the course of RT treatment, and for 2 weeks following the completion of RT).
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria 1. Ambulatory outpatients with breast (including ductal carcinoma in situ \[DCIS\]) cancer. 2. Patients to be treated with RT for curative intent. 3. Women ≥18 years of age. 4. Eastern Cooperative Oncology Group (ECOG) performance status \<3 (Appendix 4). 5. Hemoglobin ≥ 9 g/dL 6. Either post-menopausal, surgically sterilized, or willing to use an acceptable method of birth control during study treatment and for 3 months afterwards. 7. Subjects who are currently taking melatonin must discontinue melatonin for 5 days before enrolling in the study. 8. Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria 1. Fatigue brought on by conditions other than cancer such as (the indicated tests are required only if that mechanism of fatigue is suspected): * uncontrolled hypothyroidism (TSH \>10 IU) * hypercalcemia (calcium \>11 mg/dL) Calcium (Ca) = Serum Calcium (SerumCa) + 0.8 \* (NormalAlbumin - PatientAlbumin) * decompensated congestive heart failure * chronic obstructive pulmonary disease requiring oxygen replacement 2. Patients with a creatinine clearance \<30 mL/min 3. Aspartate aminotransferase (AST) \> 3X upper limit of normal (ULN) 4. Alanine aminotransferase (ALT) \> 3X ULN 5. Bilirubin \> 1X ULN 6. Use of systemic steroids, or other pharmacological agents such as methylphenidate for cancer-related fatigue 7. Current use of American ginseng, remelteon, or warfarin. 8. Depression ≥ grade 2 (CTCAE v4.0)
References
Publications (0)
Data not yet available