Clinical trial · Interventional
Exploratory Study Therapeutic Fasting Reduce Physical Limitations, Quality of Life During Aromatase Inhibitor Therapy
Exploratory Study of Therapeutic Fasting to Reduce Limitations in Physical Well-being and Quality of Life During Endocrine Therapy With Aromatase Inhibitors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Patients Treated With Aromatase Inhibitors | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fasting | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Therapeutic fasting for the reduction of physical of limitations in physical well-being and qol
- interventionNames
- Other: Fasting
Primary outcomes (4)
- measure
- Numerical rating scale
- timeFrame
- After 7 days (end of intervention)
- description
- 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.
- measure
- Brief Pain Inventory
- timeFrame
- After 7 days (end of intervention)
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDMeyer H, Koppold DA, Shaker O, Eden L, Schiffmann L, Konigorski S, Cramer H, Choi KA, Einsele H, Winkler M, Loffler C. Therapeutic Fasting as a Novel Approach to Mitigate Musculoskeletal Symptoms in Breast Cancer Patients undergoing Aromatase Inhibitor Therapy: A Feasibility Study Protocol. Integr Cancer Ther. 2026 Jan-Dec;25:15347354261426272. doi: 10.1177/15347354261426272. Epub 2026 Mar 10. PMID 41805449