Clinical trial NCT02454855: Impact of a Melatonin Supplementation on the Quality of Life in Elderly Metastatic Cancer Patients
Official title: Impact of a Melatonin Supplementation on the Quality of Life in Elderly Metastatic Cancer Patients (> = 70 Years) - PHRC-K13-170
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Cancer
Keywords: quality of life
melatonin
Elderly patient
Lead sponsor: Centre Jean Perrin
Sponsor class: OTHER
First posted: 2015-05-27
Enrollment: 123
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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.

Primary outcomes:
measure: comparison of average individual variation of overall score of QLQ-C30 of the 2 groups "Melatonin" and control (placebo)
timeFrame: 3 months
Secondary outcomes:
measure: Sub-scores of QLQ-C30 questionnaire especially dimensions "symptoms" and "functional"
timeFrame: 1 year
measure: longitudinal evolution of QLQ-C30 scores
timeFrame: 1 year
measure: Evolution of scores of QLQ-ELD14
timeFrame: 1 year
measure: sleep quality: Questionnaire Leeds
timeFrame: 1 year
measure: Fatigue: visual analog scale (VAS)
timeFrame: 1 year
measure: Pain: VAS
timeFrame: 1 year
measure: Depression: Questionnaire GDS (Geriatric Depression Scale)
timeFrame: 1 year
measure: Tolerance: assessed and graded according to the NCI-CTC (National Cancer Institute Common Toxicity Criteria) version 4.0
timeFrame: 1 year
measure: one year Overall survival rate
timeFrame: 1 year
measure: one year recurrence-free survival rate
timeFrame: 1 year
measure: Cognitive function: MMS (mini-mental score) or Folstein test
timeFrame: 1 year
measure: Evaluation of autonomy: ADL-IADL questionnaires
timeFrame: 1 year
measure: Compliance to treatment
timeFrame: 3 months
measure: evaluation of the appetite with an EVA
timeFrame: 1 year
measure: evaluation of Dietary intake with dietary questionnaires
timeFrame: 1 year
measure: Secretion of melatonin: urinary concentration of 6-sulfatoxy-melatonin (urine night 12h), with normalization on creatinuria
timeFrame: 3 months
measure: Circadian rhythms of activity / rest: survey using actimeters worn for 48 hours
timeFrame: baseline and after 3 months of treatment
Other outcomes:
Locations:
city: Angers
country: France
facility: Institut de Cancérologie de l'ouest - Site Paul Papin
city: Besançon
country: France
facility: CHU Besançon
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin
city: Lyon
country: France
facility: Centre Léon-Bérard
city: Lyon
country: France
facility: Centre Hospitalier Lyon Sud
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Reims
country: France
facility: Institut Jean Godinot
city: Saint Herblain
country: France
facility: Institut de Cancérologie de l'ouest - Site René Gauducheau
city: Saint-Priest-en-Jarez
country: France
facility: Institut de Cancérologie de la Loire Lucien Neuwirth
city: Vandœuvre-lès-Nancy
country: France
facility: Institut de cancérologie de Lorraine
city: Villejuif
country: France
facility: Hôpital Paul-Brousse
Study officials:
affiliation: Centre Jean Perrin
name: Xavier DURANDO, Pr
role: PRINCIPAL_INVESTIGATOR
References: