Exploratory Study Therapeutic Fasting Reduce Physical Limitations, Quality of Life During Aromatase Inhibitor Therapy (FREE-AI)

University Hospital Tuebingen

Status

Active, not recruiting

Conditions

Breast Cancer Patients Treated With Aromatase Inhibitors

Treatments

Other: Fasting

Study type

Interventional

Funder types

Other

Identifiers

NCT06172088

S00805-NIM

Details and patient eligibility

About

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.

Full 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)

Enrollment

54 patients

Sex

Female

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.