Exploratory Study of Therapeutic Fasting to Reduce Limitations in Physical Well-being and Quality of Life During Endocrine Therapy With Aromatase Inhibitors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Numerical rating scale
研究概览
简要总结
In this explorative study, the feasibility of therapeutic fasting to reduce limitations in physical well-being and quality of life of patients undergoing endocrine therapy with aromatase inhibitors will be investigated. In addition, the application of the StudyU app, which is currently under development, will be monitored and the app adapted if necessary. In addition, in preparation for a larger multicenter main study, it will be examined whether the muscle and joint complaints frequently experienced by patients undergoing endocrine therapy with aromatase inhibitors (AI) can be alleviated by a 7-day guided therapeutic fasting intervention (prolonged fasting / PF) can be improved.
详细描述
After baseline (t0), all patients will receive the following intervention:
7 days of online supervised prolonged therapeutic fasting (max. 350 kcal/d).
Following the study intervention, at t1, patients will be offered a for a potential effect as sustainable as possible in addition to a dietary change.
According to the following criteria:
- As plant-based as possible
- Rich in nutritive prebiotics
- In addition, this group should include intermittent fasting/time restricted eating (16/8h) into their dietary habits (at least 6d/week).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with curatively treated hormone receptor positive breast cancer who have been on aromatase inhibitors (AI) therapy for at least 3 months and have significant Pain (NRS>4).
- •Informed consent.
排除标准
- •Eating disorders.
- •Permanent medication other than endocrine therapy, which would constitute an absolute or relative contraindication to outpatient fasting, such as Marcumar, lithium, Antiepileptic drugs, etc.
- •Patients with diabetes mellitus type 1 or 2
- •Uncontrolled cerebral seizure disorder.
- •Participation in another diet/fasting study.
- •Lack of willingness to store and share personal medical data within the framework of the protocol.
- •Insufficient knowledge of the German language.
研究组 & 干预措施
Therapeutic fasting for the reduction of physical of limitations in physical well-being and qol
干预措施: Fasting (Other)
结局指标
主要结局
Numerical rating scale
时间窗: After 7 days (end of intervention)
The numerical rating scale (NRS) will be used to assess the intensity of pain on a range of 0 to 10, with 0 as no pain and 10 as the most intense pain.
Brief Pain Inventory
时间窗: After 7 days (end of intervention)
The Brief Pain Inventory (BPI) scale will measure how pain has interfered with activities of daily living (general activity, walking, work, mood, enjoyment of life, relationships with others and sleep). Pain score: 1 - 4: Mild pain, 5 - 6: Moderate pain and 7 - 10: Severe pain.
Fibromyalgia Impact Questionnaire
时间窗: After 7 days (end of intervention)
The Fibromyalgia Impact Questionnaire (FIQ) has 10 items measuring physical functioning, mood, depression, anxiety, sleep, pain, stiffness, fatigue and well-being. Each item has a maximum score of 10 points, so the overall maximum score is 100.
Health Assessment Questionnaire-Diasbility Index
时间窗: After 7 days (end of intervention)
The Health Assessment Questionnaire-Diasbility Index (HAQ-DI) will be applied to assess the daily activity of patients, consists of 20 questions and is scored from 0 (no disability) to 3 (total disability).
次要结局
- Blood pressure(Follow-up 3 Moths after the baseline.)
- Heart rate(Follow-up 3 Moths after the baseline.)
- Food habits(Follow-up 3 Moths after the baseline.)
- Fatty Liver Index(Follow-up 3 Moths after the baseline.)
- Adverse events(Follow-up 3 Moths after the baseline.)
- Relief of Cancer-related-Fatigue(Follow-up 3 Moths after the baseline.)
- World Health Organization's 5(Follow-up 3 Moths after the baseline.)
- Triglycerides(Follow-up 3 Moths after the baseline.)
- Gamma-Glutamyl-Transferase(Follow-up 3 Moths after the baseline.)
- Mindfulness and Awareness Scale(Follow-up 3 Moths after the baseline.)
- Pittsburgh Sleep Quality Index(Follow-up 3 Moths after the baseline.)
- Body-Mass-Index(Follow-up 3 Moths after the baseline.)
- Abdominal circumference(Follow-up 3 Moths after the baseline.)
- World Health Organization's 5(After 7 days (end of intervention))
- Mindfulness and Awareness Scale(After 7 days (end of intervention))
- Relief of Cancer-related-Fatigue(After 7 days (end of intervention))
- Pittsburgh Sleep Quality Index(After 7 days (end of intervention))
- Blood pressure(After 7 days (end of intervention))
- Heart rate(After 7 days (end of intervention))
- Body-Mass-Index(After 7 days (end of intervention))
- Abdominal circumference(After 7 days (end of intervention))
- Triglycerides(After 7 days (end of intervention))
- Gamma-Glutamyl-Transferase(After 7 days (end of intervention).)
- Fatty Liver Index(After 7 days (end of intervention))
- Adverse events(After 7 days (end of intervention))