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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-003505-14 | EudraCT Number |
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The study stopped for futility after the DSMB.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group "Melatonin" | Experimental | standard anticancer treatment + 3-month of melatonin supplementation |
|
| Group "Placebo" | Placebo Comparator | standard anticancer treatment + placebo (3 months) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| melatonin | Drug | Oral supplementation with melatonin (tablets) will be administered for 3 months once daily , 1-2 hours before bedtime. It will start on the day of the first administration of the new line of anticancer treatment (or no later on the day of the second administration of the new line of anticancer treatment). Melatonin supplementation is achieved by the administration of (Circadin) at a dose of 2 mg / day according to its MA form of prolonged-release tablet of 2 mg. |
| Measure | Description | Time Frame |
|---|---|---|
| comparison of average individual variation of overall score of QLQ-C30 of the 2 groups "Melatonin" and control (placebo) | The quality of life will be assessed using the QLQ-C30 questionnaire. the change in absolute value (inclusion versus after 3 months of supplementation) of overall score of QLQ-C30. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Sub-scores of QLQ-C30 questionnaire especially dimensions "symptoms" and "functional" | 1 year | |
| longitudinal evolution of QLQ-C30 scores | 1 year | |
| Evolution of scores of QLQ-ELD14 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xavier DURANDO, Pr | Centre Jean Perrin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut de Cancérologie de l'ouest - Site Paul Papin | Angers | 49000 | France | |||
| CHU Besançon |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41421991 | Derived | Ginzac 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. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D008550 | Melatonin |
| ID | Term |
|---|---|
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| placebo | Drug | Oral supplementation with placebo (tablets) will be administered for 3 months once daily , 1-2 hours before bedtime. It will start on the day of the first administration of the new line anticancer treatment (or no later on the day of the second administration of the new line of anticancer treatment). |
|
| 1 year |
| sleep quality: Questionnaire Leeds | 1 year |
| Fatigue: visual analog scale (VAS) | 1 year |
| Pain: VAS | 1 year |
| Depression: Questionnaire GDS (Geriatric Depression Scale) | 1 year |
| Tolerance: assessed and graded according to the NCI-CTC (National Cancer Institute Common Toxicity Criteria) version 4.0 | 1 year |
| one year Overall survival rate | 1 year |
| one year recurrence-free survival rate | 1 year |
| Cognitive function: MMS (mini-mental score) or Folstein test | 1 year |
| Evaluation of autonomy: ADL-IADL questionnaires | 1 year |
| Compliance to treatment | counting of remaining tablets during the 3 months of supplementation | 3 months |
| evaluation of the appetite with an EVA | Evaluation of the effect of melatonin on anorexia will be achieved through the evaluation of the appetite with an EVA 10 points. | 1 year |
| evaluation of Dietary intake with dietary questionnaires | Dietary intake may be assessed using dietary questionnaires taken on the last 3 days, only for patients at risk of malnutrition or poor nutritional status, detected during the geriatric assessment (according to the MNA questionnaire assessing status nutritional) | 1 year |
| Secretion of melatonin: urinary concentration of 6-sulfatoxy-melatonin (urine night 12h), with normalization on creatinuria | 3 months |
| Circadian rhythms of activity / rest: survey using actimeters worn for 48 hours | Evaluation for only 80 patients | baseline and after 3 months of treatment |
| Besançon |
| 25000 |
| France |
| CHU Clermont-Ferrand | Clermont-Ferrand | 63003 | France |
| Centre Jean Perrin | Clermont-Ferrand | 63011 | France |
| Centre Léon-Bérard | Lyon | 69008 | France |
| Centre Hospitalier Lyon Sud | Lyon | 69495 | France |
| Centre Antoine Lacassagne | Nice | 06100 | France |
| Institut Jean Godinot | Reims | 51056 | France |
| Institut de Cancérologie de l'ouest - Site René Gauducheau | Saint-Herblain | 44805 | France |
| Institut de Cancérologie de la Loire Lucien Neuwirth | Saint-Priest-en-Jarez | 42271 | France |
| Institut de cancérologie de Lorraine | Vandœuvre-lès-Nancy | 54519 | France |
| Hôpital Paul-Brousse | Villejuif | 94800 | France |
| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |