Therapeutic fasting to improve quality of life for breast cancer patients on aromatase inhibitors
Exploratory Study of Therapeutic Fasting to Reduce Limitations in Physical Well-being and Quality of Life During Endocrine Therapy With Aromatase Inhibitors
This study is testing if a week of guided fasting can help breast cancer patients on aromatase inhibitors feel better and improve their quality of life, especially with muscle and joint issues.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | University Hospital Tuebingen Academic / other |
| Locations | 2 sites (Stuttgart, Baden Würtenberg and 1 other locations) |
| Trial ID | NCT06172088 on ClinicalTrials.gov |
What this trial studies
This exploratory study investigates the feasibility of a 7-day guided therapeutic fasting intervention for breast cancer patients undergoing treatment with aromatase inhibitors. The aim is to assess whether fasting can alleviate physical limitations and improve quality of life, particularly focusing on muscle and joint complaints. Participants will receive online supervision during fasting and follow a plant-based, prebiotic-rich diet post-intervention. The study also aims to adapt the StudyU app for better patient support throughout the process.
Who should consider this trial
Good fit: Ideal candidates are patients with hormone receptor positive breast cancer who have been on aromatase inhibitors for at least 3 months and experience significant pain.
Not a fit: Patients with eating disorders, diabetes, or those on certain permanent medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance the quality of life for breast cancer patients undergoing aromatase inhibitor therapy.
How similar studies have performed: While the concept of therapeutic fasting is gaining interest, this specific approach in the context of aromatase inhibitor therapy is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Stuttgart, Baden Würtenberg and 1 other locations
- Robert-Bosch-Krankenhaus — Stuttgart, Baden Würtenberg, Germany (Recruiting)
- Würzburg University — Würzburg, Bayern, Germany (Recruiting)
Study contacts
- Principal investigator: Claudia Loeffler, Dr — University Hospital Wuerzburg
- Study coordinator: Claudia Loeffler, Dr
- Email: loeffler_C@ukw.de
- Phone: +4993120
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.