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

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ClinicalTrials.gov Identifier: NCT02454855
Recruitment Status : Recruiting
First Posted : May 27, 2015
Last Update Posted : June 20, 2017
Sponsor:
Information provided by (Responsible Party):
Centre Jean Perrin

Brief Summary:

Melatonin may represent an effective complementary treatment to standard chemotherapy 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 by chemotherapy.


Condition or disease Intervention/treatment Phase
Cancer Drug: melatonin Drug: placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Impact of a Melatonin Supplementation on the Quality of Life in Elderly Metastatic Cancer Patients (> = 70 Years) - PHRC-K13-170
Study Start Date : May 2015
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Melatonin

Arm Intervention/treatment
Experimental: Group "Melatonin"
standard chemotherapy + 3-month of melatonin supplementation
Drug: melatonin

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 chemotherapy.

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 chemotherapy + placebo (3 months)
Drug: placebo
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 chemotherapy.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Sub-scores of QLQ-C30 questionnaire especially dimensions "symptoms" and "functional" [ Time Frame: 1 year ]
  2. longitudinal evolution of QLQ-C30 scores [ Time Frame: 1 year ]
  3. Evolution of scores of QLQ-ELD14 [ Time Frame: 1 year ]
  4. sleep quality: Questionnaire Leeds [ Time Frame: 1 year ]
  5. Fatigue: visual analog scale (VAS) [ Time Frame: 1 year ]
  6. Pain: VAS [ Time Frame: 1 year ]
  7. Depression: Questionnaire GDS (Geriatric Depression Scale) [ Time Frame: 1 year ]
  8. Tolerance: assessed and graded according to the NCI-CTC (National Cancer Institute Common Toxicity Criteria) version 4.0 [ Time Frame: 1 year ]
  9. one year Overall survival rate [ Time Frame: 1 year ]
  10. one year recurrence-free survival rate [ Time Frame: 1 year ]
  11. Cognitive function: MMS (mini-mental score) or Folstein test [ Time Frame: 1 year ]
  12. Evaluation of autonomy: ADL-IADL questionnaires [ Time Frame: 1 year ]
  13. Compliance to treatment [ Time Frame: 3 months ]
    counting of remaining tablets during the 3 months of supplementation

  14. evaluation of the appetite with an EVA [ Time Frame: 1 year ]
    Evaluation of the effect of melatonin on anorexia will be achieved through the evaluation of the appetite with an EVA 10 points.

  15. evaluation of Dietary intake with dietary questionnaires [ Time Frame: 1 year ]
    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)

  16. Secretion of melatonin: urinary concentration of 6-sulfatoxy-melatonin (urine night 12h), with normalization on creatinuria [ Time Frame: 3 months ]
  17. Circadian rhythms of activity / rest: survey using actimeters worn for 48 hours [ Time Frame: baseline and after 3 months of treatment ]
    Evaluation for only 80 patients



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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 chemotherapy treatment with oral or IV chemotherapy
  • Patient starting chemotherapy line, in 1, 2 or 3rd line
  • 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:

  • Over 3 chemotherapy treatment lines
  • Haematological cancers
  • Indication of treatment by hormonotherapy or targeted therapy only
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02454855


Contacts
Contact: Xavier DURANDO, MD 33 473278089 Xavier.DURANDO@cjp.fr

Locations
France
Institut de Cancérologie de l'ouest - Site Paul Papin Not yet recruiting
Angers, France, 49000
Contact: Sophie ABADIE-LACOURTOISIE, MD         
CHU Besançon Not yet recruiting
Besançon, France, 25000
Contact: Alexandre KALISKI, MD         
CHU Clermont-Ferrand Active, not recruiting
Clermont-Ferrand, France, 63003
Centre Jean Perrin Recruiting
Clermont-Ferrand, France, 63011
Contact: Xavier DURANDO, MD         
Principal Investigator: Xavier DURANDO, MD         
Centre Léon-Bérard Active, not recruiting
Lyon, France, 69008
Centre Antoine Lacassagne Not yet recruiting
Nice, France, 06100
Contact: Véronique MARI, MD         
Institut de Cancérologie de l'ouest - Site René Gauducheau Not yet recruiting
Saint Herblain, France, 44805
Contact: Emmanuelle BOURBOULOUX, MD         
Hôpital Paul-Brousse Not yet recruiting
Villejuif, France, 94800
Contact: Pasquale INNOMINATO, MD         
Sponsors and Collaborators
Centre Jean Perrin
Investigators
Principal Investigator: Xavier DURANDO, MD Centre Jean Perrin

Responsible Party: Centre Jean Perrin
ClinicalTrials.gov Identifier: NCT02454855     History of Changes
Other Study ID Numbers: PHRC-K13-170
2014-003505-14 ( EudraCT Number )
First Posted: May 27, 2015    Key Record Dates
Last Update Posted: June 20, 2017
Last Verified: June 2017

Keywords provided by Centre Jean Perrin:
quality of life
melatonin
Elderly patient

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants