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

NCT06172088 | Completed DMC

• 1 other identifier: S00805-NIM
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Cancer Patients Treated With Aromatase Inhibitors

Keywords

Fasting; Aromatase Inhibitors

Outcome Measures

Primary Outcomes (4)

• Numerical rating scale

  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.

  After 7 days (end of intervention)

• Brief Pain Inventory

  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.

  After 7 days (end of intervention)

• Fibromyalgia Impact Questionnaire

  The Fibromyalgia Impact Questionnaire (FIQ) has 10 items measuring physical functioning, mood, depression, anxiety, sleep, pain, stiffness, fatigue and well-being. Each item has a maximum score of 10 points, so the overall maximum score is 100.

  After 7 days (end of intervention)

• Health Assessment Questionnaire-Diasbility Index

  The Health Assessment Questionnaire-Diasbility Index (HAQ-DI) will be applied to assess the daily activity of patients, consists of 20 questions and is scored from 0 (no disability) to 3 (total disability).

  After 7 days (end of intervention)

Secondary Outcomes (25)

• World Health Organization's 5

  After 7 days (end of intervention)

• World Health Organization's 5

  Follow-up 3 Moths after the baseline.

• Mindfulness and Awareness Scale

  After 7 days (end of intervention)

• Mindfulness and Awareness Scale

  Follow-up 3 Moths after the baseline.

• Relief of Cancer-related-Fatigue

  After 7 days (end of intervention)

Study Arms (1)

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

EXPERIMENTAL

Other: Fasting

Interventions

Fasting OTHER

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

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital Tuebingen: lead
• Charite University, Berlin, Germany: collaborator
• Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF): collaborator

Study Sites (2)

Robert-Bosch-Krankenhaus

Stuttgart, Baden Würtenberg, 70341, Germany

Location

Würzburg University

Würzburg, Bavaria, 97080, Germany

Location

Related Publications (1)

• Meyer 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 DERIVED

MeSH Terms

Conditions

Fasting

Interventions

Angptl4 protein, mouse

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Claudia Loeffler, Dr

  University Hospital Wuerzburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Bicenter, single-arm, prospective intervention study including qualitative accompanying study

Study Record Dates

• First Submitted: November 2, 2023
• First Posted: December 15, 2023
• Study Start: December 15, 2023
• Primary Completion: December 30, 2024
• Study Completion: September 30, 2025
• Last Updated: March 12, 2026

Record last verified: 2025-07

Locations

DE (2)