CancerPhase 3MEQAPAGNCT02454855
Impact of a Melatonin Supplementation on the Quality of Life in Elderly Metastatic Cancer Patients
A Phase 3 study testing melatonin in people with Cancer, run by Centre Jean Perrin at 12 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- melatonin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 123 participants
- Where
- 12 sitesFrance
- Study dates
- Jul 2015to Feb 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
France12 sites
Institut de Cancérologie de l'ouest - Site Paul Papin
Angers, 49000
CHU Besançon
Besançon, 25000
CHU Clermont-Ferrand
Clermont-Ferrand, 63003
Centre Jean Perrin
Clermont-Ferrand, 63011
Centre Léon-Bérard
Lyon, 69008
Centre Hospitalier Lyon Sud
Lyon, 69495
Centre Antoine Lacassagne
Nice, 06100
Institut Jean Godinot
Reims, 51056
Institut de Cancérologie de l'ouest - Site René Gauducheau
Saint-Herblain, 44805
Institut de Cancérologie de la Loire Lucien Neuwirth
Saint-Priest-en-Jarez, 42271
Institut de cancérologie de Lorraine
Vandœuvre-lès-Nancy, 54519
Hôpital Paul-Brousse
Villejuif, 94800
About this study
Official title: 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
melatoninDrug
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.
placeboDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| Group "Melatonin" | Experimental | standard anticancer treatment + 3-month of melatonin supplementation Receives: Drug: melatonin |
| Group "Placebo" | Placebo comparator | standard anticancer treatment + placebo (3 months) Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (17)
Sub-scores of QLQ-C30 questionnaire especially dimensions "symptoms" and "functional"
Measured: 1 year
longitudinal evolution of QLQ-C30 scores
Measured: 1 year
Evolution of scores of QLQ-ELD14
Measured: 1 year
sleep quality: Questionnaire Leeds
Measured: 1 year
Fatigue: visual analog scale (VAS)
Measured: 1 year
Pain: VAS
Measured: 1 year
Depression: Questionnaire GDS (Geriatric Depression Scale)
Measured: 1 year
Tolerance: assessed and graded according to the NCI-CTC (National Cancer Institute Common Toxicity Criteria) version 4.0
Measured: 1 year
one year Overall survival rate
Measured: 1 year
one year recurrence-free survival rate
Measured: 1 year
Cognitive function: MMS (mini-mental score) or Folstein test
Measured: 1 year
Evaluation of autonomy: ADL-IADL questionnaires
Measured: 1 year
Compliance to treatment
counting of remaining tablets during the 3 months of supplementation
Measured: 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.
Measured: 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)
Measured: 1 year
Secretion of melatonin: urinary concentration of 6-sulfatoxy-melatonin (urine night 12h), with normalization on creatinuria
Measured: 3 months
Circadian rhythms of activity / rest: survey using actimeters worn for 48 hours
Evaluation for only 80 patients
Measured: baseline and after 3 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2015 (estimated)
- Study startJul 2015
- Primary completionMay 2021
- Study completionFeb 2022
Why it stopped: The study stopped for futility after the DSMB.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Jean Perrin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xavier DURANDO, Pr, Principal investigator, Centre Jean Perrin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02454855
- Sponsor's protocol ID
- PHRC-K13-170
- Other IDs
- 2014-003505-14, 2014
- Acronym
- MEQAPAG
- Status last verified
- Mar 2022
- First submitted
- 12 May 2015
- Last updated
- 13 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ginzac A, Bourbouloux E, Rivoirard R, Jouannaud C, Hager MO, Dubois S, Kwiatkowski F, Molnar I, Thivat E, Durando X. Melatonin supplementation for quality of life in older patients with advanced cancer: a randomized controlled trial. BMC Geriatr. 2025 Dec 20;26(1):105. doi: 10.1186/s12877-025-06899-1.
PubMed 41421991
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Melatonin Supplementation on the Quality of Life in Elderly Metastatic Cancer Patients (> = 70 Years) - PHRC-K13-170
- ClinicalTrials.gov ID
- NCT02454855
- Acronym / sponsor ID
- MEQAPAG / PHRC-K13-170
- Conditions
- Cancer
- Keywords
- quality of life, melatonin, Elderly patient
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study stopped for futility after the DSMB.
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Centre Jean PerrinUniversity, hospital or other
- Study start
- Jul 2015 (actual)
- Primary completion
- May 2021 (actual)
- Study completion
- Feb 2022 (actual)
- First posted
- 27 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group "Melatonin" | Experimental | Drug: melatoninstandard anticancer treatment + 3-month of melatonin supplementation |
| Group "Placebo" | Placebo comparator | Drug: placebostandard anticancer treatment + placebo (3 months) |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (14 listed)
- Haematological cancers
- Renal failure or hepatic failure
- Auto-immune disease
- Diagnosed neurodegenerative diseases
- Unability to fill out questionnaires
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| melatoninOral 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. | Drug | Group "Melatonin" |
| placeboOral 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). | Drug | Group "Placebo" |
Primary outcome
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.
17 secondary outcomes
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
Time frame: 3 months
evaluation of the appetite with an EVA
Time frame: 1 year
evaluation of Dietary intake with dietary questionnaires
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
Time frame: baseline and after 3 months of treatment
Results and safety
The study was stopped early (reason given: The study stopped for futility after the DSMB.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2022.
- Derived from this study: PubMed 41421991Ginzac A, Bourbouloux E, Rivoirard R, Jouannaud C, Hager MO, Dubois S, Kwiatkowski F, Molnar I, Thivat E, Durando X. Melatonin supplementation for quality of life in older patients with advanced cancer: a randomized controlled trial. BMC Geriatr. 2025 Dec 20;26(1):105. doi: 10.1186/s12877-025-06899-1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xavier DURANDO, Pr principal investigator
Centre Jean Perrin
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing melatonin in people with Cancer, run by Centre Jean Perrin at 12 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study stopped for futility after the DSMB.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparison of average individual variation of overall score of QLQ-C30 of the 2 groups "Melatonin" and control (placebo) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02454855, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2022.