NCT06125353

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Harokopio University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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 (i.e., 1 mg/day) 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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-01-01
• Primary completion: 2022-05-31
• Completion: 2022-05-31
• First posted: 2023-11-09
• Last updated: 2023-11-09

Locations

1 site across 1 country: Greece