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

• Status: Active, not recruiting
• Trial end date: 2022-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Jean Perrin
• Treatments: Melatonin

Criteria

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.