A Phase 3 interventional study of melatonin and placebo in Cancer, sponsored by Centre Jean Perrin. Terminated at 12 sites in France. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2022-06-13.
Sponsored by Centre Jean Perrin · Phase 3, Interventional, and Supportive care
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.
3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.
This study's enrollment of 123 is above the median of 54 across 2,767 interventional studies indexed under Neoplasm Metastasis.
Browse Neoplasm Metastasis studies →Centre Jean Perrin is the lead sponsor of 55 studies on the registry; 9 are open to participants now.
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Exclusion Criteria:
standard anticancer treatment + 3-month of melatonin supplementation
Drug: melatonin
standard anticancer treatment + placebo (3 months)
Drug: placebo
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.
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).
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.
Time frame: 3 months
Sub-scores of QLQ-C30 questionnaire especially dimensions "symptoms" and "functional"
Time frame: 1 year
longitudinal evolution of QLQ-C30 scores
Time frame: 1 year
Evolution of scores of QLQ-ELD14
Time frame: 1 year
sleep quality: Questionnaire Leeds
Time frame: 1 year
Fatigue: visual analog scale (VAS)
Time frame: 1 year
Pain: VAS
Time frame: 1 year
Depression: Questionnaire GDS (Geriatric Depression Scale)
Time frame: 1 year
Tolerance: assessed and graded according to the NCI-CTC (National Cancer Institute Common Toxicity Criteria) version 4.0
Time frame: 1 year
one year Overall survival rate
Time frame: 1 year
one year recurrence-free survival rate
Time frame: 1 year
Cognitive function: MMS (mini-mental score) or Folstein test
Time frame: 1 year
Evaluation of autonomy: ADL-IADL questionnaires
Time frame: 1 year
Compliance to treatment
counting of remaining tablets during the 3 months of supplementation
Time frame: 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.
Time frame: 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)
Time frame: 1 year
Secretion of melatonin: urinary concentration of 6-sulfatoxy-melatonin (urine night 12h), with normalization on creatinuria
Time frame: 3 months
Circadian rhythms of activity / rest: survey using actimeters worn for 48 hours
Evaluation for only 80 patients
Time frame: baseline and after 3 months of treatment
This study is terminated, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Centre Jean Perrin