Clinical trial · Interventional
The Effect of Melatonin Supplementation on Fatigue Symptoms During Chemotherapy Treatment of Breast Cancer Patients
NCT06125353CI-TRIAL-00071221completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of the present 3-month randomized, placebo-controlled trial was to evaluate whether adherence to Mediterranean Diet (MD) together with melatonin oral treatment or plaebo, would ameliorate Cancer Related Fatigue in Breast Cancer patients receiving chemotherapy treatment.
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 | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Melatonin | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- intervention group
- description
- Participants in the Intervention group consumed one melatonin tablet per day, containing 1mg of melatonin, for a total of three months.
- interventionNames
- Dietary Supplement: Melatonin
- type
- NO_INTERVENTION
- label
- placebo group
- description
- Participants in this group were instructed to consume one placebo tablet (with water) every day for a total of three months. Melatonin and placebo tablets were of similar physical and sensory properties.
Primary outcomes (1)
- measure
- Cancer Related Fatigue
- timeFrame
- three months
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: 1. adult women (≥ 18 years of age) with BC diagnosis who underwent chemotherapy at the time of invitation, 2. women receiving pharmacological treatment that did not interact with melatonin, 3. women receiving standard pharmacological treatment for at least last two months prior to study initiation, 4. patients with good performance status, as indicated by scoring "0 or 1" of the Eastern Cooperative Oncology Performance Status (ECOG PS) questionnaire \[26\], 5. patients not needing a transfusion, as indicated by hemoglobin ≥ 9 g/dL, 6. patients having the ability to understand and give a written statement of consent. Patients were excluded from the study when: 7. fatigue was attributed to conditions other than cancer e.g., uncontrolled hypothyroidism, hypercalcemia, congestive heart failure, chronic obstructive pulmonary disease, 8. using pharmacological agents for CRF or sleeping disorders prior to the study, 9. pharmacological treatment that was modified during the study or that could interact with melatonin, 10. diagnosed with gastrointestinal diseases that could affect absorption of nutrients such as inflammatory bowel diseases infections. 11. diagnosed with psychiatric disorders such as depression, psychosis, bipolar disorder, and receiving equivalent medication. 12. excessive alcohol consumption. 13. a lifestyle that can affect sleep patterns (e.g., night shifts). 14. patients with a poor clinical state as indicated by laboratory markers: creatinine clearance \< 30 mL/min; aspartate aminotransferase (AST) \> 3 x upper limit of normal (ULN); alanine aminotransferase (ALT) \> 3 x ULN; bilirubin \> 1 x ULN.
References
Publications (0)
Data not yet available
No reference posted for this study.