The Effect of Melatonin Supplementation on Fatigue Symptoms During Chemotherapy Treatment of Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Cancer Related Fatigue
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- 未提供
研究组 & 干预措施
placebo group
Participants in this group were instructed to consume one placebo tablet (with water) every day for a total of three months. Melatonin and placebo tablets were of similar physical and sensory properties.
intervention group
Participants in the Intervention group consumed one melatonin tablet per day, containing 1mg of melatonin, for a total of three months.
干预措施: Melatonin (Dietary Supplement)
结局指标
主要结局
Cancer Related Fatigue
时间窗: 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.
次要结局
未报告次要终点
研究者
Frantzeska Nimee
Principal Investigator
Harokopio University