Impact of a Melatonin Supplementation on the Quality of Life in Elderly Metastatic Cancer Patients (MEQAPAG)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02454855|
Recruitment Status : Recruiting
First Posted : May 27, 2015
Last Update Posted : June 20, 2017
Melatonin may represent an effective complementary treatment to standard chemotherapy 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 by chemotherapy.
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Drug: melatonin Drug: placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Impact of a Melatonin Supplementation on the Quality of Life in Elderly Metastatic Cancer Patients (> = 70 Years) - PHRC-K13-170|
|Study Start Date :||May 2015|
|Estimated Primary Completion Date :||May 2019|
|Estimated Study Completion Date :||September 2019|
Experimental: Group "Melatonin"
standard chemotherapy + 3-month of melatonin supplementation
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 chemotherapy.
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.
Placebo Comparator: Group "Placebo"
standard chemotherapy + placebo (3 months)
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 chemotherapy.
- comparison of average individual variation of overall score of QLQ-C30 of the 2 groups "Melatonin" and control (placebo) [ Time Frame: 3 months ]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.
- Sub-scores of QLQ-C30 questionnaire especially dimensions "symptoms" and "functional" [ Time Frame: 1 year ]
- longitudinal evolution of QLQ-C30 scores [ Time Frame: 1 year ]
- Evolution of scores of QLQ-ELD14 [ Time Frame: 1 year ]
- sleep quality: Questionnaire Leeds [ Time Frame: 1 year ]
- Fatigue: visual analog scale (VAS) [ Time Frame: 1 year ]
- Pain: VAS [ Time Frame: 1 year ]
- Depression: Questionnaire GDS (Geriatric Depression Scale) [ Time Frame: 1 year ]
- Tolerance: assessed and graded according to the NCI-CTC (National Cancer Institute Common Toxicity Criteria) version 4.0 [ Time Frame: 1 year ]
- one year Overall survival rate [ Time Frame: 1 year ]
- one year recurrence-free survival rate [ Time Frame: 1 year ]
- Cognitive function: MMS (mini-mental score) or Folstein test [ Time Frame: 1 year ]
- Evaluation of autonomy: ADL-IADL questionnaires [ Time Frame: 1 year ]
- Compliance to treatment [ Time Frame: 3 months ]counting of remaining tablets during the 3 months of supplementation
- evaluation of the appetite with an EVA [ Time Frame: 1 year ]Evaluation of the effect of melatonin on anorexia will be achieved through the evaluation of the appetite with an EVA 10 points.
- evaluation of Dietary intake with dietary questionnaires [ Time Frame: 1 year ]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)
- Secretion of melatonin: urinary concentration of 6-sulfatoxy-melatonin (urine night 12h), with normalization on creatinuria [ Time Frame: 3 months ]
- Circadian rhythms of activity / rest: survey using actimeters worn for 48 hours [ Time Frame: baseline and after 3 months of treatment ]Evaluation for only 80 patients
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02454855
|Contact: Xavier DURANDO, MD||33 473278089||Xavier.DURANDO@cjp.fr|
|Institut de Cancérologie de l'ouest - Site Paul Papin||Not yet recruiting|
|Angers, France, 49000|
|Contact: Sophie ABADIE-LACOURTOISIE, MD|
|CHU Besançon||Not yet recruiting|
|Besançon, France, 25000|
|Contact: Alexandre KALISKI, MD|
|CHU Clermont-Ferrand||Active, not recruiting|
|Clermont-Ferrand, France, 63003|
|Centre Jean Perrin||Recruiting|
|Clermont-Ferrand, France, 63011|
|Contact: Xavier DURANDO, MD|
|Principal Investigator: Xavier DURANDO, MD|
|Centre Léon-Bérard||Active, not recruiting|
|Lyon, France, 69008|
|Centre Antoine Lacassagne||Not yet recruiting|
|Nice, France, 06100|
|Contact: Véronique MARI, MD|
|Institut de Cancérologie de l'ouest - Site René Gauducheau||Not yet recruiting|
|Saint Herblain, France, 44805|
|Contact: Emmanuelle BOURBOULOUX, MD|
|Hôpital Paul-Brousse||Not yet recruiting|
|Villejuif, France, 94800|
|Contact: Pasquale INNOMINATO, MD|
|Principal Investigator:||Xavier DURANDO, MD||Centre Jean Perrin|