Status:
ACTIVE_NOT_RECRUITING
Exploratory Study Therapeutic Fasting Reduce Physical Limitations, Quality of Life During Aromatase Inhibitor Therapy
Lead Sponsor:
University Hospital Tuebingen
Collaborating Sponsors:
Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)
Charite University, Berlin, Germany
Conditions:
Breast Cancer Patients Treated With Aromatase Inhibitors
Eligibility:
FEMALE
18-70 years
Phase:
NA
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 wi...
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, patie...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2025
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT06172088
Start Date
December 15 2023
End Date
September 30 2025
Last Update
July 31 2025
Active Locations (2)
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1
Robert-Bosch-Krankenhaus
Stuttgart, Baden Würtenberg, Germany, 70341
2
Würzburg University
Würzburg, Bavaria, Germany, 97080