NCT02454855

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

Impact of a Melatonin Supplementation on the Quality of Life in Elderly Metastatic Cancer Patients (> = 70 Years) - PHRC-K13-170

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 123 (actual)
• Sponsor: Centre Jean Perrin · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cancer

Interventions

Type	Name	Description
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 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	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 anticancer treatment (or no later on the day of the second administration of the new line of anticancer treatment).

Timeline

• Start date: 2015-07-01
• Primary completion: 2021-05-01
• Completion: 2022-02-01
• First posted: 2015-05-27
• Last updated: 2022-06-13

Locations

12 sites across 1 country: France