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

Phase 3

Terminated

• Conditions: Cancer
• Interventions: Drug: melatonin; Drug: placebo

• Registration Number: NCT02454855
• Lead Sponsor: Centre Jean Perrin

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-05-12
• Study First Submitted QC: 2015-05-22
• Study First Posted: 2015-05-27
• Study Start: 2015-07
• Primary Completion: 2021-05
• Study Completion: 2022-02
• Status Verified: 2022-03
• Last Update Submitted: 2022-06-10
• Last Update Posted: 2022-06-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 123

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group "Melatonin"	melatonin	standard anticancer treatment + 3-month of melatonin supplementation
Group "Placebo"	placebo	standard anticancer treatment + placebo (3 months)

Primary Outcome Measures

Name	Time	Method
comparison of average individual variation of overall score of QLQ-C30 of the 2 groups "Melatonin" and control (placebo)	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.

Secondary Outcome Measures

Name	Time	Method
Fatigue: visual analog scale (VAS)	1 year
Pain: VAS	1 year
Depression: Questionnaire GDS (Geriatric Depression Scale)	1 year
sleep quality: Questionnaire Leeds	1 year
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
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	3 months	counting of remaining tablets during the 3 months of supplementation
evaluation of the appetite with an EVA	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	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	3 months
Circadian rhythms of activity / rest: survey using actimeters worn for 48 hours	baseline and after 3 months of treatment	Evaluation for only 80 patients

Trial Locations

Locations (12)

Centre Hospitalier Lyon Sud; 🇫🇷 Lyon, France

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France

Centre Jean Perrin; 🇫🇷 Clermont-Ferrand, France

Centre Léon-Bérard; 🇫🇷 Lyon, France

Centre Antoine Lacassagne; 🇫🇷 Nice, France

Institut de Cancérologie de l'ouest - Site René Gauducheau; 🇫🇷 Saint Herblain, France

CHU Besançon; 🇫🇷 Besançon, France

Hôpital Paul-Brousse; 🇫🇷 Villejuif, France

Institut de Cancérologie de l'ouest - Site Paul Papin; 🇫🇷 Angers, France

Institut Jean Godinot; 🇫🇷 Reims, France

Institut de Cancérologie de la Loire Lucien Neuwirth; 🇫🇷 Saint-Priest-en-Jarez, France

Institut de cancérologie de Lorraine; 🇫🇷 Vandœuvre-lès-Nancy, France