Clinical trial NCT06172088: Exploratory Study Therapeutic Fasting Reduce Physical Limitations, Quality of Life During Aromatase Inhibitor Therapy
Official title: Exploratory Study of Therapeutic Fasting to Reduce Limitations in Physical Well-being and Quality of Life During Endocrine Therapy With Aromatase Inhibitors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer Patients Treated With Aromatase Inhibitors
Keywords: Fasting
Aromatase Inhibitors
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
Collaborators: name: Robert Bosch Gesellschaft für Medizinische Forschung mbH
name: Charite University, Berlin, Germany
First posted: 2023-12-15
Enrollment: 54
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Bicenter, single-arm, prospective intervention study including qualitative accompanying study
Primary purpose: TREATMENT

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)

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.

Primary outcomes:
measure: Numerical rating scale
timeFrame: After 7 days (end of intervention)
measure: Brief Pain Inventory
timeFrame: After 7 days (end of intervention)
measure: Fibromyalgia Impact Questionnaire
timeFrame: After 7 days (end of intervention)
measure: Health Assessment Questionnaire-Diasbility Index
timeFrame: After 7 days (end of intervention)
Secondary outcomes:
measure: World Health Organization's 5
timeFrame: After 7 days (end of intervention)
measure: World Health Organization's 5
timeFrame: Follow-up 3 Moths after the baseline.
measure: Mindfulness and Awareness Scale
timeFrame: After 7 days (end of intervention)
measure: Mindfulness and Awareness Scale
timeFrame: Follow-up 3 Moths after the baseline.
measure: Relief of Cancer-related-Fatigue
timeFrame: After 7 days (end of intervention)
measure: Relief of Cancer-related-Fatigue
timeFrame: Follow-up 3 Moths after the baseline.
measure: Pittsburgh Sleep Quality Index
timeFrame: After 7 days (end of intervention)
measure: Pittsburgh Sleep Quality Index
timeFrame: Follow-up 3 Moths after the baseline.
measure: Blood pressure
timeFrame: After 7 days (end of intervention)
measure: Blood pressure
timeFrame: Follow-up 3 Moths after the baseline.
measure: Heart rate
timeFrame: After 7 days (end of intervention)
measure: Heart rate
timeFrame: Follow-up 3 Moths after the baseline.
measure: Food habits
timeFrame: Follow-up 3 Moths after the baseline.
measure: Body-Mass-Index
timeFrame: After 7 days (end of intervention)
measure: Body-Mass-Index
timeFrame: Follow-up 3 Moths after the baseline.
measure: Abdominal circumference
timeFrame: After 7 days (end of intervention)
measure: Abdominal circumference
timeFrame: Follow-up 3 Moths after the baseline.
measure: Triglycerides
timeFrame: After 7 days (end of intervention)
measure: Triglycerides
timeFrame: Follow-up 3 Moths after the baseline.
measure: Gamma-Glutamyl-Transferase
timeFrame: After 7 days (end of intervention).
measure: Gamma-Glutamyl-Transferase
timeFrame: Follow-up 3 Moths after the baseline.
measure: Fatty Liver Index
timeFrame: After 7 days (end of intervention)
measure: Fatty Liver Index
timeFrame: Follow-up 3 Moths after the baseline.
measure: Adverse events
timeFrame: After 7 days (end of intervention)
measure: Adverse events
timeFrame: Follow-up 3 Moths after the baseline.
Other outcomes:
Locations:
city: Stuttgart
country: Germany
facility: Robert-Bosch-Krankenhaus
state: Baden Würtenberg
city: Würzburg
country: Germany
facility: Würzburg University
state: Bayern
Study officials:
affiliation: University Hospital Wuerzburg
name: Claudia Loeffler, Dr
role: PRINCIPAL_INVESTIGATOR
References: