Ignite Creation Date:
2024-05-06 @ 7:46 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06125353
Status:
COMPLETED
Last Update Posted:
2023-11-09
First Post:
2023-10-10
Brief Title:
The Effect of Melatonin Supplementation on Fatigue Symptoms During Chemotherapy Treatment of Breast Cancer Patients
Sponsor:
Harokopio University
Organization:
Harokopio University
Study Overview
Official Title:
The Effect of Melatonin Supplementation on Fatigue Symptoms During Chemotherapy Treatment of Breast Cancer Patients
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of the present 3-month randomized placebo-controlled trial was to evaluate whether adherence to Mediterranean Diet MD together with melatonin oral treatment or plaebo would ameliorate Cancer Related Fatigue in Breast Cancer patients receiving chemotherapy treatment
Detailed Description:
Cancer related fatigue CRF is a common distressing complaint in breast cancer BC patients treated with chemotherapy Nutrition quality plays a pivotal role in CRF while an increased interest towards new pharmacological agents has been observed
Melatonin an endogenous hormone that regulates the human sleep-wake cycle could alleviate CRF
In the present randomized placebo-controlled 3-month trial we investigated the effects of melatonin intake ie 1 mgday vs placebo on CRF of BC patients Melatonin and placebo tablets were of similar physical and sensory properties In both arms Mediterranean diet MD was implemented Medical history anthropometry and blood withdrawal were performed CRF was evaluated by the Functional Assessment of Chronic Illness Therapy - Fatigue questionnaire and MD adherence by the MedDiet Score
Melatonin an endogenous hormone that regulates the human sleep-wake cycle could alleviate CRF
In the present randomized placebo-controlled 3-month trial we investigated the effects of melatonin intake ie 1 mgday vs placebo on CRF of BC patients Melatonin and placebo tablets were of similar physical and sensory properties In both arms Mediterranean diet MD was implemented Medical history anthropometry and blood withdrawal were performed CRF was evaluated by the Functional Assessment of Chronic Illness Therapy - Fatigue questionnaire and MD adherence by the MedDiet Score
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| D231052019 | OTHER | The Ethics Committee of IASO Hospital | None |