NCT02454855

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
123

participants targeted

Target at P25-P50 for phase_3 cancer

Timeline
Completed

Started Jul 2015

Longer than P75 for phase_3 cancer

Geographic Reach
1 country

12 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 27, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

June 13, 2022

Status Verified

March 1, 2022

Enrollment Period

5.8 years

First QC Date

May 12, 2015

Last Update Submit

June 10, 2022

Conditions

Cancer

Keywords

quality of lifemelatoninElderly patient

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 months

Secondary Outcomes (17)

  • Sub-scores of QLQ-C30 questionnaire especially dimensions "symptoms" and "functional"

    1 year

  • longitudinal evolution of QLQ-C30 scores

    1 year

  • Evolution of scores of QLQ-ELD14

    1 year

  • sleep quality: Questionnaire Leeds

    1 year

  • Fatigue: visual analog scale (VAS)

    1 year

  • +12 more secondary outcomes

Study Arms (2)

Group "Melatonin"

EXPERIMENTAL

standard anticancer treatment + 3-month of melatonin supplementation

Drug: melatonin

Group "Placebo"

PLACEBO COMPARATOR

standard anticancer treatment + placebo (3 months)

Drug: placebo

Interventions

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.

Group "Melatonin"
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).

Group "Placebo"

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Institut de Cancérologie de l'ouest - Site Paul Papin

Angers, 49000, France

Location

CHU Besançon

Besançon, 25000, France

Location

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Centre Jean Perrin

Clermont-Ferrand, 63011, France

Location

Centre Léon-Bérard

Lyon, 69008, France

Location

Centre Hospitalier Lyon Sud

Lyon, 69495, France

Location

Centre Antoine Lacassagne

Nice, 06100, France

Location

Institut Jean Godinot

Reims, 51056, France

Location

Institut de Cancérologie de l'ouest - Site René Gauducheau

Saint-Herblain, 44805, France

Location

Institut de Cancérologie de la Loire Lucien Neuwirth

Saint-Priest-en-Jarez, 42271, France

Location

Institut de cancérologie de Lorraine

Vandœuvre-lès-Nancy, 54519, France

Location

Hôpital Paul-Brousse

Villejuif, 94800, France

Location

Related Publications (1)

  • 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. doi: 10.1186/s12877-025-06899-1. Online ahead of print.

    PMID: 41421991DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

Melatonin

Intervention Hierarchy (Ancestors)

TryptaminesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Xavier DURANDO, Pr

    Centre Jean Perrin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2015

First Posted

May 27, 2015

Study Start

July 1, 2015

Primary Completion

May 1, 2021

Study Completion

February 1, 2022

Last Updated

June 13, 2022

Record last verified: 2022-03

Locations

FR(12)