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

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NCT-Nummer:
NCT06172088

Studienbeginn:
Dezember 2023

Letztes Update:
15.12.2023

Wirkstoff:
-

Geschlecht:
Frauen

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
University Hospital Tuebingen

Collaborator:
Robert Bosch Hospital Stuttgart, Charite University, Berlin, Germany,

Studienleiter

Claudia Loeffler, Dr
Principal Investigator
University Hospital Wuerzburg

Kontakt

Studienlocations
(2 von 2)

Brustzentrum Robert-Bosch-Krankenhaus
Auerbachstraße 110
70376 Stuttgart
Deutschland» Google-Maps
Ansprechpartner:
Marcela Winkler, Dr
Phone: 0711-8101
Phone (ext.): 2073
E-Mail: marcela.winkler@rbk.de
» Ansprechpartner anzeigen

Studien-Informationen

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)

Ein-/Ausschlusskriterien

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.

Studien-Rationale

Primary outcome:

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 outcome:

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.

Geprüfte Regime

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

Quelle: ClinicalTrials.gov


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