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Completed

NCT Number: NCT06172088

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Robert-Bosch-Krankenhaus, Stuttgart, Baden Würtenberg, Germany

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About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fasting

Other

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

Primary outcomes

  1. Numerical rating scale

    Time frame: After 7 days (end of intervention)

    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.

  2. Brief Pain Inventory

    Time frame: After 7 days (end of intervention)

    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.

  3. Fibromyalgia Impact Questionnaire

    Time frame: After 7 days (end of intervention)

    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.

  4. Health Assessment Questionnaire-Diasbility Index

    Time frame: After 7 days (end of intervention)

    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).

Secondary outcomes

  1. World Health Organization's 5

    Time frame: After 7 days (end of intervention)

    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.

  2. World Health Organization's 5

    Time frame: Follow-up 3 Moths after the baseline.

    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.

  3. Mindfulness and Awareness Scale

    Time frame: After 7 days (end of intervention)

    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.

  4. Mindfulness and Awareness Scale

    Time frame: Follow-up 3 Moths after the baseline.

    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.

  5. Relief of Cancer-related-Fatigue

    Time frame: After 7 days (end of intervention)

    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.

  6. Relief of Cancer-related-Fatigue

    Time frame: Follow-up 3 Moths after the baseline.

    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.

  7. Pittsburgh Sleep Quality Index

    Time frame: After 7 days (end of intervention)

    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.

  8. Pittsburgh Sleep Quality Index

    Time frame: Follow-up 3 Moths after the baseline.

    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.

  9. Blood pressure

    Time frame: After 7 days (end of intervention)

    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.

  10. Blood pressure

    Time frame: Follow-up 3 Moths after the baseline.

    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.

  11. Heart rate

    Time frame: After 7 days (end of intervention)

    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.

  12. Heart rate

    Time frame: Follow-up 3 Moths after the baseline.

    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.

  13. Food habits

    Time frame: Follow-up 3 Moths after the baseline.

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

  14. Body-Mass-Index

    Time frame: After 7 days (end of intervention)

    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).

  15. Body-Mass-Index

    Time frame: Follow-up 3 Moths after the baseline.

    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).

  16. Abdominal circumference

    Time frame: After 7 days (end of intervention)

    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.

  17. Abdominal circumference

    Time frame: Follow-up 3 Moths after the baseline.

    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.

  18. Triglycerides

    Time frame: After 7 days (end of intervention)

    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.

  19. Triglycerides

    Time frame: Follow-up 3 Moths after the baseline.

    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.

  20. Gamma-Glutamyl-Transferase

    Time frame: After 7 days (end of intervention).

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

  21. Gamma-Glutamyl-Transferase

    Time frame: Follow-up 3 Moths after the baseline.

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

  22. Fatty Liver Index

    Time frame: After 7 days (end of intervention)

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

  23. Fatty Liver Index

    Time frame: Follow-up 3 Moths after the baseline.

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

  24. Adverse events

    Time frame: After 7 days (end of intervention)

    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.

  25. Adverse events

    Time frame: Follow-up 3 Moths after the baseline.

    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.

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Collaborators

  • Charite University, Berlin, Germany
  • Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)

Registry information

Official study title

Exploratory Study of Therapeutic Fasting to Reduce Limitations in Physical Well-being and Quality of Life During Endocrine Therapy With Aromatase Inhibitors

Acronym: FREE-AI

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Dec 15, 2023
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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