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

Cancer Clinical Trial

— MEQAPAG  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02454855
• Other study ID #: PHRC-K13-170
• Secondary ID: 2014-003505-14
• Status: Terminated
• Phase: Phase 3
• Start date: July 2015
• Est. completion date: February 2022

Study information

• Verified date: March 2022
• Source: Centre Jean Perrin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 123
• Est. completion date: February 2022
• Est. primary completion date: May 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Neoplasm Metastasis

Intervention

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
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).

Locations

Country	Name	City	State
France	Institut de Cancérologie de l'ouest - Site Paul Papin	Angers
France	CHU Besançon	Besançon
France	Centre Jean Perrin	Clermont-Ferrand
France	CHU Clermont-Ferrand	Clermont-Ferrand
France	Centre Hospitalier Lyon Sud	Lyon
France	Centre Léon-Bérard	Lyon
France	Centre Antoine Lacassagne	Nice
France	Institut Jean Godinot	Reims
France	Institut de Cancérologie de l'ouest - Site René Gauducheau	Saint Herblain
France	Institut de Cancérologie de la Loire Lucien Neuwirth	Saint-Priest-en-Jarez
France	Institut de cancérologie de Lorraine	Vandœuvre-lès-Nancy
France	Hôpital Paul-Brousse	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
Centre Jean Perrin

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Sub-scores of QLQ-C30 questionnaire especially dimensions "symptoms" and "functional"		1 year
Secondary	longitudinal evolution of QLQ-C30 scores		1 year
Secondary	Evolution of scores of QLQ-ELD14		1 year
Secondary	sleep quality: Questionnaire Leeds		1 year
Secondary	Fatigue: visual analog scale (VAS)		1 year
Secondary	Pain: VAS		1 year
Secondary	Depression: Questionnaire GDS (Geriatric Depression Scale)		1 year
Secondary	Tolerance: assessed and graded according to the NCI-CTC (National Cancer Institute Common Toxicity Criteria) version 4.0		1 year
Secondary	one year Overall survival rate		1 year
Secondary	one year recurrence-free survival rate		1 year
Secondary	Cognitive function: MMS (mini-mental score) or Folstein test		1 year
Secondary	Evaluation of autonomy: ADL-IADL questionnaires		1 year
Secondary	Compliance to treatment	counting of remaining tablets during the 3 months of supplementation	3 months
Secondary	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
Secondary	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
Secondary	Secretion of melatonin: urinary concentration of 6-sulfatoxy-melatonin (urine night 12h), with normalization on creatinuria		3 months
Secondary	Circadian rhythms of activity / rest: survey using actimeters worn for 48 hours	Evaluation for only 80 patients	baseline and after 3 months of treatment