NCT06172088

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: University Hospital Tuebingen · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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). All patients will be interviewed on a regular basis and anthropometric data will be collected accordingly at following time points: * t1 (at the end of the fasting intervention). * t2 (3 months after t0)

Conditions

• Breast Cancer Patients Treated With Aromatase Inhibitors

Interventions

Type	Name	Description
OTHER	Fasting	Sieben days of online supervised prolonged therapeutic fasting (max. 350 kcal/d).

Timeline

• Start date: 2023-12-15
• Primary completion: 2024-12-30
• Completion: 2025-09-30
• First posted: 2023-12-15
• Last updated: 2026-03-12

Locations

2 sites across 1 country: Germany