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

Primary Purpose

Cancer

Status
Terminated
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
melatonin
placebo
Sponsored by
Centre Jean Perrin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer focused on measuring quality of life, melatonin, Elderly patient

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Institut de Cancérologie de l'ouest - Site Paul Papin
  • CHU Besançon
  • CHU Clermont-Ferrand
  • Centre Jean Perrin
  • Centre Léon-Bérard
  • Centre Hospitalier Lyon Sud
  • Centre Antoine Lacassagne
  • Institut Jean Godinot
  • Institut de Cancérologie de l'ouest - Site René Gauducheau
  • Institut de Cancérologie de la Loire Lucien Neuwirth
  • Institut de cancérologie de Lorraine
  • Hôpital Paul-Brousse

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Group "Melatonin"

Group "Placebo"

Arm Description

standard anticancer treatment + 3-month of melatonin supplementation

standard anticancer treatment + placebo (3 months)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Sub-scores of QLQ-C30 questionnaire especially dimensions "symptoms" and "functional"
longitudinal evolution of QLQ-C30 scores
Evolution of scores of QLQ-ELD14
sleep quality: Questionnaire Leeds
Fatigue: visual analog scale (VAS)
Pain: VAS
Depression: Questionnaire GDS (Geriatric Depression Scale)
Tolerance: assessed and graded according to the NCI-CTC (National Cancer Institute Common Toxicity Criteria) version 4.0
one year Overall survival rate
one year recurrence-free survival rate
Cognitive function: MMS (mini-mental score) or Folstein test
Evaluation of autonomy: ADL-IADL questionnaires
Compliance to treatment
counting of remaining tablets during the 3 months of supplementation
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.
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)
Secretion of melatonin: urinary concentration of 6-sulfatoxy-melatonin (urine night 12h), with normalization on creatinuria
Circadian rhythms of activity / rest: survey using actimeters worn for 48 hours
Evaluation for only 80 patients

Full Information

First Posted
May 12, 2015
Last Updated
June 10, 2022
Sponsor
Centre Jean Perrin
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1. Study Identification

Unique Protocol Identification Number
NCT02454855
Brief Title
Impact of a Melatonin Supplementation on the Quality of Life in Elderly Metastatic Cancer Patients
Acronym
MEQAPAG
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

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Terminated
Why Stopped
The study stopped for futility after the DSMB.
Study Start Date
July 2015 (Actual)
Primary Completion Date
May 2021 (Actual)
Study Completion Date
February 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Jean Perrin

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer
Keywords
quality of life, melatonin, Elderly patient

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
123 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group "Melatonin"
Arm Type
Experimental
Arm Description
standard anticancer treatment + 3-month of melatonin supplementation
Arm Title
Group "Placebo"
Arm Type
Placebo Comparator
Arm Description
standard anticancer treatment + placebo (3 months)
Intervention Type
Drug
Intervention Name(s)
melatonin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
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).
Primary Outcome Measure Information:
Title
comparison of average individual variation of overall score of QLQ-C30 of the 2 groups "Melatonin" and control (placebo)
Description
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
Secondary Outcome Measure Information:
Title
Sub-scores of QLQ-C30 questionnaire especially dimensions "symptoms" and "functional"
Time Frame
1 year
Title
longitudinal evolution of QLQ-C30 scores
Time Frame
1 year
Title
Evolution of scores of QLQ-ELD14
Time Frame
1 year
Title
sleep quality: Questionnaire Leeds
Time Frame
1 year
Title
Fatigue: visual analog scale (VAS)
Time Frame
1 year
Title
Pain: VAS
Time Frame
1 year
Title
Depression: Questionnaire GDS (Geriatric Depression Scale)
Time Frame
1 year
Title
Tolerance: assessed and graded according to the NCI-CTC (National Cancer Institute Common Toxicity Criteria) version 4.0
Time Frame
1 year
Title
one year Overall survival rate
Time Frame
1 year
Title
one year recurrence-free survival rate
Time Frame
1 year
Title
Cognitive function: MMS (mini-mental score) or Folstein test
Time Frame
1 year
Title
Evaluation of autonomy: ADL-IADL questionnaires
Time Frame
1 year
Title
Compliance to treatment
Description
counting of remaining tablets during the 3 months of supplementation
Time Frame
3 months
Title
evaluation of the appetite with an EVA
Description
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
Title
evaluation of Dietary intake with dietary questionnaires
Description
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
Title
Secretion of melatonin: urinary concentration of 6-sulfatoxy-melatonin (urine night 12h), with normalization on creatinuria
Time Frame
3 months
Title
Circadian rhythms of activity / rest: survey using actimeters worn for 48 hours
Description
Evaluation for only 80 patients
Time Frame
baseline and after 3 months of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xavier DURANDO, Pr
Organizational Affiliation
Centre Jean Perrin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut de Cancérologie de l'ouest - Site Paul Papin
City
Angers
ZIP/Postal Code
49000
Country
France
Facility Name
CHU Besançon
City
Besançon
ZIP/Postal Code
25000
Country
France
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
Centre Jean Perrin
City
Clermont-Ferrand
ZIP/Postal Code
63011
Country
France
Facility Name
Centre Léon-Bérard
City
Lyon
ZIP/Postal Code
69008
Country
France
Facility Name
Centre Hospitalier Lyon Sud
City
Lyon
ZIP/Postal Code
69495
Country
France
Facility Name
Centre Antoine Lacassagne
City
Nice
ZIP/Postal Code
06100
Country
France
Facility Name
Institut Jean Godinot
City
Reims
ZIP/Postal Code
51056
Country
France
Facility Name
Institut de Cancérologie de l'ouest - Site René Gauducheau
City
Saint Herblain
ZIP/Postal Code
44805
Country
France
Facility Name
Institut de Cancérologie de la Loire Lucien Neuwirth
City
Saint-Priest-en-Jarez
ZIP/Postal Code
42271
Country
France
Facility Name
Institut de cancérologie de Lorraine
City
Vandœuvre-lès-Nancy
ZIP/Postal Code
54519
Country
France
Facility Name
Hôpital Paul-Brousse
City
Villejuif
ZIP/Postal Code
94800
Country
France

12. IPD Sharing Statement

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

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