Clinical trial · Interventional
Impact of a Melatonin Supplementation on the Quality of Life in Elderly Metastatic Cancer Patients
Impact of a Melatonin Supplementation on the Quality of Life in Elderly Metastatic Cancer Patients (> = 70 Years) - PHRC-K13-170
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study stopped for futility after the DSMB.
Summary
Brief summary (as posted)
Melatonin may represent an effective complementary treatment to standard anticancer treatments in order to reduce asthenia, depression, sleep disturbances, cognitive impairment and performance status as part of quality of life. Moreover, melatonin has been evaluated in several clinical trials in cancer patients with no side effects. It could be particularly of interest in elderly cancer patients as they exhibit a significant deficiency of melatonin production . The investigators propose to perform a prospective and randomized study to study the effect of a melatonin supplementation on the quality of life of elderly advanced/metastatic cancer patients (age ≥ 70) treated for a locally advanced or metastatic cancer.
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 |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| melatonin | Drug | — | UNRESOLVED |
| placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group "Melatonin"
- description
- standard anticancer treatment + 3-month of melatonin supplementation
- interventionNames
- Drug: melatonin
- type
- PLACEBO_COMPARATOR
- label
- Group "Placebo"
- description
- standard anticancer treatment + placebo (3 months)
- interventionNames
- Drug: placebo
Primary outcomes (1)
- measure
- comparison of average individual variation of overall score of QLQ-C30 of the 2 groups "Melatonin" and control (placebo)
- timeFrame
- 3 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Age \> = 70 years. * Performance status \< = 2 (WHO criteria) * Life expectancy \> 3months * A patient with solid tumor locally advanced or metastatic * Indication of systemic anticancer treatment : oral or IV chemotherapy, endocrine therapy, target therapy or immunotherapy * MMS-orientation ≥ 7 (geriatric Mini Mental State face-to-face questionnaire) * Able to swallow and retain oral treatment * Patient who signed the participation consent before entering the trial * Patient able to read, write and understand French. * Affiliation to the french social security scheme (or beneficiary of such a scheme) under the terms of the law of 9 August 2004. Exclusion Criteria: * Haematological cancers * Renal failure or hepatic failure * Auto-immune disease * Diagnosed neurodegenerative diseases * Unability to fill out questionnaires * melatonin treatment ongoing or completed for less than 3 months * Treatment with an investigational drug, participation to another therapeutic clinical trial within \<30 days * Hypersensitivity to melatonin or any of the excipients * Current Treatment with fluvoxamine, 5- or 8-methoxypsoralen, cimetidine, estrogen * A history of known or suspected excessive alcohol use. * Patient refusing to participate and / or unable to give informed consent * Patient unable to complete the questionnaires even with the help of a relative or a nurse * Patient does not have the capacity to comply with the study requirements * Patient deprived of liberty by a court or administrative.
References
Publications (1)
- DERIVEDGinzac A, Bourbouloux E, Rivoirard R, Jouannaud C, Hager MO, Dubois S, Kwiatkowski F, Molnar I, Thivat E, Durando X. Melatonin supplementation for quality of life in older patients with advanced cancer: a randomized controlled trial. BMC Geriatr. 2025 Dec 20;26(1):105. doi: 10.1186/s12877-025-06899-1. PMID 41421991