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Aromatase Inhibitors

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

Fasting

Claudia Loeffler, Dr

Marcela Winkler, Dr

Claudia Löffler, Dr

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.

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)

Bicenter, single-arm, prospective intervention study including qualitative accompanying study

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

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.

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.

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.

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).

The WHO-5 questionnaire will be used to assess the subjective mental well-being of patients. Each question is scored from 0 to 5. Low scores correspond to low level of well-being.

The Mindfulness and Awareness Scale (MAAS) measures a person's level of mindfulness in daily life. It evaluates how much time an individual spends in the present time. The scale ranges from 1 to 6 and consists of 15 items in total.

The Relief of Cancer-related-Fatigue (BFI) is used to quickly assess the severity and impact of cancer-related fatigue. The questionnaire consists of 10 items covering six dimensions: Activity, mood, walking ability, work, relationship with others, and enjoyment of life. A score between 30 and 40 indicates moderate fatigue, scores above 70 indicate severe fatigue.

The Pittsburgh Sleep Quality Index (PSQI) measures subjective sleep quality. The questionnaire consists of 19 items and 7 component scores are obtained, each of which is scored from 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.

It is defined as the force exerted by the blood on the arterial walls to circulate through the arteries and is measured in mm Hg. A normal value is considered to be less than 120/80 mmHg.

It is defined as the number of times the heart pumps blood during a minute and is measured as the number of beats per minute. Between 60 and 100 beats per minute is considered a normal value.

A standardized questionnaire will be used, where the following will be recorded: eating habits.

Body-Mass-Index (BMI) is a measure of body weight classification and is calculated based on weight and height, with the unit of measurement kg/m2. A BMI between 18.5 and 24.9 is considered normal weight, between 25 and 29.9 is defined as slightly overweight and a value above 30 is called severely overweight (obesity).

It is an anthropometric measurement used to establish the fat accumulated in a person in the abdominal area and is measured in centimeters (cm). For women, below 80cm is low risk, 80-88cm is high risk and more than 88cm is very high.

Type of lipid found in the bloodstream and adipose tissue. Normal values are between 150-199 mg/dl, high between 200-499 mg/dl and very high values above 500 mg/dl.

This is an enzyme found mainly in the liver. Its normal values are between 5-40 U/L.

Fatty Liver Index (FLI) is a predictor of hepatic steatosis, calculated from BMI, waist circumference, y-GT and triglycerides.

Adverse events and serious adverse events are documented. Adverse events include any adverse symptoms, illnesses, disorders, or accidents that occur during the course of the study. Serious adverse events include events occurring during the course of the study that are immediately life-threatening and/or result in serious health problems (specifically, requiring unanticipated hospitalization or prolongation of hospitalization, or resulting in serious disability or incapacitation). The severity as well as the possible causal relationship with the intervention will be assessed by the study physician.

Spots Global Cancer Trial Database for breast cancer patients treated with aromatase inhibitors