Exploratory Study of Therapeutic Fasting to Reduce Limitations in Physical Well-being and Quality of Life During Endocrine Therapy With Aromatase Inhibitors
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 54
- Locations
- 2
- Primary Endpoint
- Numerical rating scale
Study Overview
Brief Summary
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.
Detailed Description
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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
Therapeutic fasting for the reduction of physical of limitations in physical well-being and qol
Intervention: Fasting (Other)
Outcomes
Primary Outcomes
Numerical rating scale
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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).
Secondary Outcomes
- 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))