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

Centre Jean Perrin

Status and phase

Terminated

Phase 3

Conditions

Cancer

Treatments

Drug: placebo

Drug: melatonin

Study type

Interventional

Funder types

Other

Identifiers

NCT02454855

2014-003505-14 (EudraCT Number)

PHRC-K13-170

Details and patient eligibility

About

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.

Enrollment

123 patients

Sex

All

Ages

70+ years old

Volunteers

No Healthy Volunteers

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.