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

Overview
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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.

Sponsor: No sponsor defined

SEEK ID: https://ldh.hpi.imise.uni-leipzig.de/projects/3

Public web page: https://www.forschung-hilft.de/de/forschungsprojekte/free-ai-therapeutisches-fasten-nach-brustkrebs-zur-symptomkontrolle-unter-aromatase-inhibitoren

NFDI4Health PIs: No PIs for this Trial Project

Trial Project start date: 15th Dec 2023

Trial Project end date: 30th Sep 2025

Extended Metadata (Nfdi4Health MDS 3.3)

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Resource classification(*)

Type of the resource(*) : Study

Title(s)/name(s) of the Project

Title/name(*) : Exploratory Study Therapeutic Fasting Reduce Physical Limitations, Quality of Life During Aromatase Inhibitor Therapy
Language of the title/name(*) : English

Title/name(*) : FREE-AI: Therapeutisches Fasten nach Brustkrebs zur Symptomkontrolle unter Aromatase Inhibitoren
Language of the title/name(*) : German

Acronym(s) of the Project

Acronym(*) : FREE-AI
Language of the acronym(*) : German

Description(s) of the Project

Description(*) : 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.
Language of the description(*) : English

Keyword(s) describing the Project

Keyword(*) : Fasting, Aromatase Inhibitors

Language(s) of the project : German

Web page of the project : https://clinicaltrials.gov/study/NCT06172088

Contributor(s) of the Project

Is it a personal or organisational contribution?(*) : Organisational
Details about the contributing organisation(s)/institution(s)/group(s)
Contributor type(*) : Data collector
Funding identifier(s) : Not specified
Name of the organisation/institution/group(*) : Comprehensive Cancer Center Mainfranken (CCC MF), Universitätsklinikum Würzburg
Details about the contributing person(s)
Contributor type(*) : Principal investigator
Given name(*) : Claudia
Family name(s)(*) : Loeffler
Digital identifier(s)
Identifier(*) : 0000-0001-8866-110X
Scheme(*) : ORCID
Email address : koi-studien_ccc@ukw.de
Phone number : +49931-20135350
Organisation(s) associated with the contributor
Name(*) : Comprehensive Cancer Center Mainfranken (CCC MF), Universitätsklinikum Würzburg
Address : Oberdürrbacher Str. 6, 97080 Würzburg, Germany
Web page : https://www.ukw.de/ccc/
Digital identifier(s)
Identifier(*) : 03pvr2g57
Scheme(*) : ROR
Name(*) : Robert-Bosch-Krankenhaus GmbH
Address : Auerbachstraße 110, 70376 Stuttgart, Germany
Web page : https://www.rbk.de
Digital identifier(s)
Identifier(*) : 034nkkr84
Scheme(*) : ROR
Identifier(*) : Not specified
Scheme(*) : Not specified
Name(*) : Charité – Universitätsmedizin Berlin
Address : Charitéplatz 1, 10117 Berlin, Germany
Web page : https://www.charite.de
Digital identifier(s)
Identifier(*) : 001w7jn25
Scheme(*) : ROR
Identifier(*) : Not specified
Scheme(*) : Not specified

Alternative identifiers

Type of the registry(*) : NCT (ClinicalTrials.gov)
Identifier(*) : NCT06172088

Collects nutritional data? : true

Includes chronic diseases? : true

Characteristics of the Project

Is it an interventional or non-interventional Project? : Interventional
Specification of the type of the Project
Interventional Project type : Single group
Non-interventional Project type : []
Primary health condition(s) or disease(s) considered in the Project
Primary health condition or disease name(*) : Breast Cancer Patients Treated With Aromatase Inhibitors
Terminology/classification(*) : MeSH
Code of the health condition or disease : D001943
Groups of diseases or conditions(*)
Which groups of diseases or conditions were the data collected on? : Neoplasms (II)
On which diseases or conditions were the data collected? : Lower level ICD-10 (https://icd.who.int/browse10/2019/en), with autocomplete
Collects mortality data? : No
Administrative information about the Project
Status of the ethics committee approval : Request for approval submitted, approval granted
Overall Project status : Ongoing (II): Recruitment and data collection ongoing
Participants enrolled by invitation? : No
Start date : 15 December 2023
End date : 30 September 2025
Mono- or multicentric? : Multicentric
Number of centers : 3
One or more data providers? : Several data providers
Number of data providers : 3
Primary subject(*) : Person
Eligibility criteria for Project participants
Eligibility criteria: Minimum age
Minimum eligible age(*) : 18
Unit of age(*) : Years
Eligibility criteria: Maximum age
Maximum eligible age(*) : 70
Unit of age(*) : Years
Eligible gender : Female
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."
Population of the Project(*)
Coverage : National
Country(ies) : Germany
Region(s) and/or city(ies) : Würzburg, Stuttgart, Berlin
Interventions of the Project
Name of the intervention(*) : Therapeutic fasting
Type of the intervention : Behavioral (e.g., psychotherapy, lifestyle counseling)
Additional information about the intervention : Seven days of online supervised prolonged therapeutic fasting (max. 350 kcal/d).
Name(s) of the arm(s) associated with the given intervention : Not specified
Exposures of the Project
Name of the exposure : Not specified
Type of the exposure : Not specified
Additional information about the exposure : Not specified
Name(s) of the group(s) associated with the given exposure : Not specified
Outcome measures in the Project
Name of the outcome measure(*) : Numerical rating scale
Description of the outcome measure : 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.
Type of the outcome measure : Primary
Time point(s) of assessment : After 7 days (end of intervention)
Name of the outcome measure(*) : Brief Pain Inventory
Description of the outcome measure : 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.
Type of the outcome measure : Primary
Time point(s) of assessment : After 7 days (end of intervention)
Name of the outcome measure(*) : Fibromyalgia Impact Questionnaire
Description of the outcome measure : 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.
Type of the outcome measure : Primary
Time point(s) of assessment : After 7 days (end of intervention)
Name of the outcome measure(*) : Health Assessment Questionnaire-Diasbility Index
Description of the outcome measure : 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).
Type of the outcome measure : Primary
Time point(s) of assessment : After 7 days (end of intervention)
Name of the outcome measure(*) : World Health Organization's 5
Description of the outcome measure : 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.
Type of the outcome measure : Secondary
Time point(s) of assessment : After 7 days (end of intervention
Name of the outcome measure(*) : World Health Organization's 5
Description of the outcome measure : 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.
Type of the outcome measure : Secondary
Time point(s) of assessment : Follow-up 3 Moths after the baseline.
Name of the outcome measure(*) : Mindfulness and Awareness Scale
Description of the outcome measure : 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.
Type of the outcome measure : Secondary
Time point(s) of assessment : After 7 days (end of intervention)
Name of the outcome measure(*) : Mindfulness and Awareness Scale
Description of the outcome measure : 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.
Type of the outcome measure : Secondary
Time point(s) of assessment : Follow-up 3 Moths after the baseline.
Name of the outcome measure(*) : Relief of Cancer-related-Fatigue
Description of the outcome measure : 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.
Type of the outcome measure : Secondary
Time point(s) of assessment : After 7 days (end of intervention)
Name of the outcome measure(*) : Relief of Cancer-related-Fatigue
Description of the outcome measure : 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.
Type of the outcome measure : Secondary
Time point(s) of assessment : Follow-up 3 Moths after the baseline.
Name of the outcome measure(*) : Pittsburgh Sleep Quality Index
Description of the outcome measure : 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.
Type of the outcome measure : Secondary
Time point(s) of assessment : After 7 days (end of intervention)
Name of the outcome measure(*) : Pittsburgh Sleep Quality Index
Description of the outcome measure : 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.
Type of the outcome measure : Secondary
Time point(s) of assessment : Follow-up 3 Moths after the baseline.
Name of the outcome measure(*) : Heart rate
Description of the outcome measure : 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.
Type of the outcome measure : Secondary
Time point(s) of assessment : After 7 days (end of intervention)
Name of the outcome measure(*) : Heart rate
Description of the outcome measure : 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.
Type of the outcome measure : Secondary
Time point(s) of assessment : Follow-up 3 Moths after the baseline.
Name of the outcome measure(*) : Food habits
Description of the outcome measure : A standardized questionnaire will be used, where the following will be recorded: eating habits.
Type of the outcome measure : Secondary
Time point(s) of assessment : Follow-up 3 Moths after the baseline.
Name of the outcome measure(*) : Body-Mass-Index
Description of the outcome measure : 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).
Type of the outcome measure : Secondary
Time point(s) of assessment : After 7 days (end of intervention)
Name of the outcome measure(*) : Body-Mass-Index
Description of the outcome measure : 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).
Type of the outcome measure : Secondary
Time point(s) of assessment : Follow-up 3 Moths after the baseline.
Name of the outcome measure(*) : Abdominal circumference
Description of the outcome measure : 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 the outcome measure : Secondary
Time point(s) of assessment : After 7 days (end of intervention)
Name of the outcome measure(*) : Abdominal circumference
Description of the outcome measure : 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 the outcome measure : Secondary
Time point(s) of assessment : Follow-up 3 Moths after the baseline.
Name of the outcome measure(*) : Triglycerides
Description of the outcome measure : 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.
Type of the outcome measure : Secondary
Time point(s) of assessment : After 7 days (end of intervention)
Name of the outcome measure(*) : Triglycerides
Description of the outcome measure : 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.
Type of the outcome measure : Secondary
Time point(s) of assessment : Follow-up 3 Moths after the baseline.
Name of the outcome measure(*) : Gamma-Glutamyl-Transferase
Description of the outcome measure : This is an enzyme found mainly in the liver. Its normal values are between 5-40 U/L.
Type of the outcome measure : Secondary
Time point(s) of assessment : After 7 days (end of intervention).
Name of the outcome measure(*) : Gamma-Glutamyl-Transferase
Description of the outcome measure : This is an enzyme found mainly in the liver. Its normal values are between 5-40 U/L.
Type of the outcome measure : Secondary
Time point(s) of assessment : Follow-up 3 Moths after the baseline.
Name of the outcome measure(*) : Fatty Liver Index
Description of the outcome measure : Fatty Liver Index (FLI) is a predictor of hepatic steatosis, calculated from BMI, waist circumference, y-GT and triglycerides.
Type of the outcome measure : Secondary
Time point(s) of assessment : After 7 days (end of intervention).
Name of the outcome measure(*) : Fatty Liver Index
Description of the outcome measure : Fatty Liver Index (FLI) is a predictor of hepatic steatosis, calculated from BMI, waist circumference, y-GT and triglycerides.
Type of the outcome measure : Secondary
Time point(s) of assessment : Follow-up 3 Moths after the baseline.
Name of the outcome measure(*) : Adverse events
Description of the outcome measure : 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.
Type of the outcome measure : Secondary
Time point(s) of assessment : After 7 days (end of intervention)
Name of the outcome measure(*) : Adverse events
Description of the outcome measure : 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.
Type of the outcome measure : Secondary
Time point(s) of assessment : Follow-up 3 Moths after the baseline.
Additional information about the Project : Not specified
Additional assessments/measurements in the Project : Diet/Nutrition, Waist circumference, Body Mass Index, Body fat percentage
Data sharing strategy of the Project(*)
Is it planned to share the data?(*) : Undecided, it is not yet known if data will be made available
Supporting documents available in addition to the data : []
When and for how long will the data be available? : Not specified
Criteria for data access : Not specified
Additional information about data sharing : Not specified
DataSHIELD/Opal infrastructure available? : Not specified
Link to data request application : Not specified
Web page with additional information about data sharing : Not specified
Record linkage possible? : Not specified
Non-interventional aspects of the Project
Temporal design : Prospective
Target follow-up duration of the Project
Target follow-up duration(*) : 3
Unit of time(*) : Months
Number of follow-ups conducted : 1
Biosamples retained in a biorepository : None retained
Specific types of retained biosamples : Not specified
Interventional aspects of the Project
Numerical phase : Not applicable
Masking of intervention(s) assignment
Masking implemented? : false
Who is masked? : []
Additional information about masking : Not specified
Type of allocation of participants to an arm : Not applicable (for single-arm trials)
Off-label use of a drug product : No

Annotated Properties

Topic annotations

Preclinical and clinical studies, Nutritional science, Endocrinology and metabolism

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

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