- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02454855
Impact of a Melatonin Supplementation on the Quality of Life in Elderly Metastatic Cancer Patients (MEQAPAG)
Impact of a Melatonin Supplementation on the Quality of Life in Elderly Metastatic Cancer Patients (> = 70 Years) - PHRC-K13-170
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.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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-
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Angers, France, 49000
- Institut de cancérologie de l'Ouest - Site Paul Papin
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Besançon, France, 25000
- CHU Besançon
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Clermont-Ferrand, France, 63003
- CHU Clermont-Ferrand
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Clermont-Ferrand, France, 63011
- Centre Jean Perrin
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Lyon, France, 69495
- Centre Hospitalier Lyon Sud
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Lyon, France, 69008
- Centre Leon-Berard
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Nice, France, 06100
- Centre Antoine Lacassagne
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Reims, France, 51056
- Institut Jean Godinot
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Saint Herblain, France, 44805
- Institut de Cancérologie de l'Ouest - Site René Gauducheau
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Saint-Priest-en-Jarez, France, 42271
- Institut de Cancérologie de la Loire Lucien Neuwirth
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Vandœuvre-lès-Nancy, France, 54519
- Institut de Cancérologie de Lorraine
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Villejuif, France, 94800
- Hôpital Paul-Brousse
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group "Melatonin"
standard anticancer treatment + 3-month of melatonin supplementation
|
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 Comparator: Group "Placebo"
standard anticancer treatment + placebo (3 months)
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
comparison of average individual variation of overall score of QLQ-C30 of the 2 groups "Melatonin" and control (placebo)
Time Frame: 3 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sub-scores of QLQ-C30 questionnaire especially dimensions "symptoms" and "functional"
Time Frame: 1 year
|
1 year
|
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longitudinal evolution of QLQ-C30 scores
Time Frame: 1 year
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1 year
|
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Evolution of scores of QLQ-ELD14
Time Frame: 1 year
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1 year
|
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sleep quality: Questionnaire Leeds
Time Frame: 1 year
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1 year
|
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Fatigue: visual analog scale (VAS)
Time Frame: 1 year
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1 year
|
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Pain: VAS
Time Frame: 1 year
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1 year
|
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Depression: Questionnaire GDS (Geriatric Depression Scale)
Time Frame: 1 year
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1 year
|
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Tolerance: assessed and graded according to the NCI-CTC (National Cancer Institute Common Toxicity Criteria) version 4.0
Time Frame: 1 year
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1 year
|
|
one year Overall survival rate
Time Frame: 1 year
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1 year
|
|
one year recurrence-free survival rate
Time Frame: 1 year
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1 year
|
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Cognitive function: MMS (mini-mental score) or Folstein test
Time Frame: 1 year
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1 year
|
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Evaluation of autonomy: ADL-IADL questionnaires
Time Frame: 1 year
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1 year
|
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Compliance to treatment
Time Frame: 3 months
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counting of remaining tablets during the 3 months of supplementation
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3 months
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evaluation of the appetite with an EVA
Time Frame: 1 year
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Evaluation of the effect of melatonin on anorexia will be achieved through the evaluation of the appetite with an EVA 10 points.
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1 year
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evaluation of Dietary intake with dietary questionnaires
Time Frame: 1 year
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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)
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1 year
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Secretion of melatonin: urinary concentration of 6-sulfatoxy-melatonin (urine night 12h), with normalization on creatinuria
Time Frame: 3 months
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3 months
|
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Circadian rhythms of activity / rest: survey using actimeters worn for 48 hours
Time Frame: baseline and after 3 months of treatment
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Evaluation for only 80 patients
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baseline and after 3 months of treatment
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PHRC-K13-170
- 2014-003505-14 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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