Impact of a Melatonin Supplementation on the Quality of Life in Elderly Metastatic Cancer Patients

Study Overview
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Brief Summary
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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.

Official Title
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Impact of a Melatonin Supplementation on the Quality of Life in Elderly Metastatic Cancer Patients (> = 70 Years) - PHRC-K13-170

Conditions
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Cancer

Intervention / Treatment
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* Drug: melatonin
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group Melatonin<br>standard anticancer treatment + 3-month of melatonin supplementation | Drug: melatonin<br>* 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.<br>|
| Placebo Comparator: Group Placebo<br>standard anticancer treatment + placebo (3 months) | Drug: placebo<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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quality of life, melatonin, Elderly patient