The Effect of Melatonin Supplementation on Fatigue Symptoms During Chemotherapy Treatment of Breast Cancer Patients
- Conditions
- Breast Cancer
- Interventions
- Dietary Supplement: Melatonin
- Registration Number
- NCT06125353
- Lead Sponsor
- Harokopio University
- 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 (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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 56
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description intervention group Melatonin Participants in the Intervention group consumed one melatonin tablet per day, containing 1mg of melatonin, for a total of three months.
- Primary Outcome Measures
Name Time Method Cancer Related Fatigue three months Whether melatonin can ameliorate cancer related fatigue in breast cancer patients. Cancer related fatigue was evaluated by the Functional Assessment of Chronic Illness Therapy - Fatigue questionnaire. It is a 40-item scale that assesses self-reported fatigue in terms of daily activities and function. It has five subscale domains: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, Functional Well-Being, and Fatigue. For each question there are five answers (Not at all, A little bit, Somewhat, Quite a bit, Very much). Scoring ranges between 0 and 160. The higher the score, the better the participant's well-being.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Iaso Hospital
🇬🇷Athens, Greece