A Randomized Controlled Trial to Evaluate the Effect of a Tailored Program of Physical Activity and Nutritional Counseling on Fatigue Reduction in Breast Cancer Patients Receiving Adjuvant Treatment.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Subjective fatigue
研究概览
简要总结
Cancer-related fatigue is by far the most common symptom affecting cancer patients. Combining regular dietary counseling and tailored physical activity is associated with reduced cancer-related fatigue and can improve quality of life and body weight control. We propose to conduct a randomized controlled trial which purpose is to evaluate the effect of an intervention combining physical exercise and nutritional therapeutic education on cancer-related fatigue. To gain behavioral change towards PA and nutrition habits, interventions will take place within hospitals, on the same days of adjuvant treatments.
详细描述
Cancer-related fatigue is by far the most common symptom affecting cancer patients. Combining regular dietary counseling and tailored physical activity is associated with reduced cancer-related fatigue and can improve quality of life and body weight control. We propose to conduct a randomized controlled trial which purpose is to evaluate the effect of an intervention combining physical exercise and nutritional therapeutic education on cancer-related fatigue. To gain behavioral change towards PA and nutrition habits, interventions will take place within hospitals, on the same days of adjuvant treatments.
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
- None
入排标准
- 年龄范围
- 18 Years 至 76 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patient with histologically proven breast cancer
- •18-76 years old
- •Patients having undergone curative surgery and eligible to 6 cycles of adjuvant chemotherapy (6 FEC100, or 3FEC100 + taxanes) followed by radiotherapy
- •Satisfactory healing of breast and lymph nodes area
- •Ability to understand the nature, goal and study methodology
- •Consent to cooperate for clinical assessments
- •Affiliation to a social security regime or beneficiary of equivalent social protection
- •Written informed consent provided before any study specific procedures
排除标准
- •HER2 positive or metastatic cancer
- •Any other primary tumor
- •Contraindication to moderate physical activity
- •Contraindication to adjuvant chemotherapy or radiotherapy
- •Pregnancy or breast feeding
- •Inability to attend or comply with interventions or follow-up scheduling, disability or difficulty preventing a proper understanding of trial
研究组 & 干预措施
Intervention arm
干预措施: Tailored program of PA and nutritional counseling (Behavioral)
Control arm
Routine practice
结局指标
主要结局
Subjective fatigue
时间窗: At 18 months
Subjective fatigue is measured using the Multidimensional Fatigue Inventory (MFI-20) questionnaire
次要结局
- Physical activity level(At 18 months)
- Anxiety/depressive symptoms(At 18 months)
- Attention fatigue(At 18 months)
- Body Mass Index(At 18 months)
- Quality of life(At 18 months)
- Muscular fatigue(At 18 months)
- Body composition(At 18 months)