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The Effect of Melatonin Supplementation on Fatigue Symptoms During Chemotherapy Treatment of Breast Cancer Patients

NCT06125353 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2023-11-09

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Melatonin

Patients of the Intervention group (melatonin group) received a personalized dietary plan based on the Mediterranean Diet, together with a booklet of lifestyle guidelines (nutritional and physical activity), all generated by a Clinical Decision Support System (CDSS). Moreover, participants in the Intervention group consumed one melatonin tablet per day, containing 1 mg of melatonin, together with water for a total of three months.

Sponsors & Collaborators

  • Harokopio University

    lead OTHER

Principal Investigators

  • Maria Skouroliakou, Dr · Harokopio University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2022-05-31
Completion
2022-05-31

Countries

  • Greece

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06125353 on ClinicalTrials.gov