Exploratory Study Therapeutic Fasting Reduce Physical Limitations, Quality of Life During Aromatase Inhibitor Therapy

NCT ID: NCT06172088

Last Updated: 2025-07-31

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-15
• Study Completion Date: 2025-09-30

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).

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Therapeutic fasting for the reduction of physical of limitations in physical well-being and qol

Group Type: EXPERIMENTAL

Fasting

Intervention Type: OTHER

Sieben days of online supervised prolonged therapeutic fasting (max. 350 kcal/d).

Interventions

Fasting

Sieben days of online supervised prolonged therapeutic fasting (max. 350 kcal/d).

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)

OTHER

Sponsor Role: collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role: collaborator

University Hospital Tuebingen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Claudia Loeffler, Dr

Role: PRINCIPAL_INVESTIGATOR

University Hospital Wuerzburg

Locations

Robert-Bosch-Krankenhaus

Stuttgart, Baden Würtenberg, Germany

Würzburg University

Würzburg, Bavaria, Germany

Countries

Germany

Other Identifiers

S00805-NIM

Identifier Type: -

Identifier Source: org_study_id