Status:
COMPLETED
The Effect of Melatonin Supplementation on Fatigue Symptoms During Chemotherapy Treatment of Breast Cancer Patients
Lead Sponsor:
Harokopio University
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
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 Canc...
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 towa...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- adult women (≥ 18 years of age) with BC diagnosis who underwent chemotherapy at the time of invitation,
- women receiving pharmacological treatment that did not interact with melatonin,
- women receiving standard pharmacological treatment for at least last two months prior to study initiation,
- patients with good performance status, as indicated by scoring "0 or 1" of the Eastern Cooperative Oncology Performance Status (ECOG PS) questionnaire \[26\],
- patients not needing a transfusion, as indicated by hemoglobin ≥ 9 g/dL,
- patients having the ability to understand and give a written statement of consent.
- Patients were excluded from the study when:
- fatigue was attributed to conditions other than cancer e.g., uncontrolled hypothyroidism, hypercalcemia, congestive heart failure, chronic obstructive pulmonary disease,
- using pharmacological agents for CRF or sleeping disorders prior to the study,
- pharmacological treatment that was modified during the study or that could interact with melatonin,
- diagnosed with gastrointestinal diseases that could affect absorption of nutrients such as inflammatory bowel diseases infections.
- diagnosed with psychiatric disorders such as depression, psychosis, bipolar disorder, and receiving equivalent medication.
- excessive alcohol consumption.
- a lifestyle that can affect sleep patterns (e.g., night shifts).
- patients with a poor clinical state as indicated by laboratory markers: creatinine clearance \< 30 mL/min; aspartate aminotransferase (AST) \> 3 x upper limit of normal (ULN); alanine aminotransferase (ALT) \> 3 x ULN; bilirubin \> 1 x ULN.
Exclusion
Key Trial Info
Start Date :
January 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2022
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT06125353
Start Date
January 1 2022
End Date
May 31 2022
Last Update
November 9 2023
Active Locations (1)
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1
Iaso Hospital
Athens, Greece