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

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

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.

Study Overview

• Status: Terminated
• Conditions: Cancer
• Intervention / Treatment: Drug: melatonin; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 123
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Angers, France, 49000
    • Institut de Cancérologie de l'Ouest - Site Paul Papin
  • Besançon, France, 25000
    • CHU Besançon
  • Clermont-Ferrand, France, 63003
    • Chu Clermont-Ferrand
  • Clermont-Ferrand, France, 63011
    • Centre Jean Perrin
  • Lyon, France, 69495
    • Centre Hospitalier Lyon Sud
  • Lyon, France, 69008
    • Centre Leon-Berard
  • Nice, France, 06100
    • Centre Antoine Lacassagne
  • Reims, France, 51056
    • Institut Jean Godinot
  • Saint Herblain, France, 44805
    • Institut de Cancérologie de l'Ouest - Site René Gauducheau
  • Saint-Priest-en-Jarez, France, 42271
    • Institut de Cancérologie de la Loire Lucien Neuwirth
  • Vandœuvre-lès-Nancy, France, 54519
    • Institut de Cancerologie de Lorraine
  • Villejuif, France, 94800
    • Hôpital Paul-Brousse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group "Melatonin"; standard anticancer treatment + 3-month of melatonin supplementation	Drug: melatonin; 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.
Placebo Comparator: Group "Placebo"; standard anticancer treatment + placebo (3 months)	Drug: placebo; 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).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Jean Perrin

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2015
• Primary Completion (Actual): May 1, 2021
• Study Completion (Actual): February 1, 2022

Study Registration Dates

• First Submitted: May 12, 2015
• First Submitted That Met QC Criteria: May 22, 2015
• First Posted (Estimate): May 27, 2015

Study Record Updates

• Last Update Posted (Actual): June 13, 2022
• Last Update Submitted That Met QC Criteria: June 10, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: melatonin; quality of life; Elderly patient
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Protective Agents; Antioxidants; Melatonin
• Other Study ID Numbers: PHRC-K13-170; 2014-003505-14 (EudraCT Number)