Breast Cancer Patients Treated With Aromatase InhibitorsFREE-AINCT06172088
Exploratory Study Therapeutic Fasting Reduce Physical Limitations, Quality of Life During Aromatase Inhibitor Therapy
A study testing Fasting in people with Breast Cancer Patients Treated With Aromatase Inhibitors, run by University Hospital Tuebingen at 2 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer Patients Treated With Aromatase Inhibitors
- What is being tested?
- Fasting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 2 sitesGermany
- Study dates
- 15 Dec 2023to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Robert-Bosch-Krankenhaus
Stuttgart, Baden Würtenberg, 70341
Würzburg University
Würzburg, Bavaria, 97080
About this study
Official title: Exploratory Study of Therapeutic Fasting to Reduce Limitations in Physical Well-being and Quality of Life During Endocrine Therapy With Aromatase Inhibitors
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.
Read the 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)
- Being tested
- Fasting
- Keywords
- Fasting, Aromatase Inhibitors
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FastingOther
Sieben days of online supervised prolonged therapeutic fasting (max. 350 kcal/d).
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic fasting for the reduction of physical of limitations in physical well-being and qol | Experimental | Not described Receives: Other: Fasting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical rating scale
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.
Measured: After 7 days (end of intervention)
Brief Pain Inventory
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.
Measured: After 7 days (end of intervention)
Fibromyalgia Impact Questionnaire
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.
Measured: After 7 days (end of intervention)
Health Assessment Questionnaire-Diasbility Index
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).
Measured: After 7 days (end of intervention)
Secondary outcomes (25)
World Health Organization's 5
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.
Measured: After 7 days (end of intervention)
World Health Organization's 5
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.
Measured: Follow-up 3 Moths after the baseline.
Mindfulness and Awareness Scale
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.
Measured: After 7 days (end of intervention)
Mindfulness and Awareness Scale
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.
Measured: Follow-up 3 Moths after the baseline.
Relief of Cancer-related-Fatigue
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.
Measured: After 7 days (end of intervention)
Relief of Cancer-related-Fatigue
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.
Measured: Follow-up 3 Moths after the baseline.
Pittsburgh Sleep Quality Index
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.
Measured: After 7 days (end of intervention)
Pittsburgh Sleep Quality Index
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.
Measured: Follow-up 3 Moths after the baseline.
Blood pressure
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.
Measured: After 7 days (end of intervention)
Blood pressure
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.
Measured: Follow-up 3 Moths after the baseline.
Heart rate
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.
Measured: After 7 days (end of intervention)
Heart rate
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.
Measured: Follow-up 3 Moths after the baseline.
Food habits
A standardized questionnaire will be used, where the following will be recorded: eating habits.
Measured: Follow-up 3 Moths after the baseline.
Body-Mass-Index
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).
Measured: After 7 days (end of intervention)
Body-Mass-Index
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).
Measured: Follow-up 3 Moths after the baseline.
Abdominal circumference
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.
Measured: After 7 days (end of intervention)
Abdominal circumference
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.
Measured: Follow-up 3 Moths after the baseline.
Triglycerides
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.
Measured: After 7 days (end of intervention)
Triglycerides
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.
Measured: Follow-up 3 Moths after the baseline.
Gamma-Glutamyl-Transferase
This is an enzyme found mainly in the liver. Its normal values are between 5-40 U/L.
Measured: After 7 days (end of intervention).
Gamma-Glutamyl-Transferase
This is an enzyme found mainly in the liver. Its normal values are between 5-40 U/L.
Measured: Follow-up 3 Moths after the baseline.
Fatty Liver Index
Fatty Liver Index (FLI) is a predictor of hepatic steatosis, calculated from BMI, waist circumference, y-GT and triglycerides.
Measured: After 7 days (end of intervention)
Fatty Liver Index
Fatty Liver Index (FLI) is a predictor of hepatic steatosis, calculated from BMI, waist circumference, y-GT and triglycerides.
Measured: Follow-up 3 Moths after the baseline.
Adverse events
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.
Measured: After 7 days (end of intervention)
Adverse events
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.
Measured: Follow-up 3 Moths after the baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start15 Dec 2023
- Primary completion30 Dec 2024
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer Patients Treated With Aromatase InhibitorsStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Bicenter, single-arm, prospective intervention study including qualitative accompanying study
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF), Charite University, Berlin, Germany
- Responsible party
- Sponsor
- Investigators
- Claudia Loeffler, Dr, Principal investigator, Wuerzburg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06172088
- Sponsor's protocol ID
- S00805-NIM
- Acronym
- FREE-AI
- Status last verified
- Jul 2025
- First submitted
- 2 Nov 2023
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Meyer H, Koppold DA, Shaker O, Eden L, Schiffmann L, Konigorski S, Cramer H, Choi KA, Einsele H, Winkler M, Loffler C. Therapeutic Fasting as a Novel Approach to Mitigate Musculoskeletal Symptoms in Breast Cancer Patients undergoing Aromatase Inhibitor Therapy: A Feasibility Study Protocol. Integr Cancer Ther. 2026 Jan-Dec;25:15347354261426272. doi: 10.1177/15347354261426272. Epub 2026 Mar 10.
PubMed 41805449
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study of Therapeutic Fasting to Reduce Limitations in Physical Well-being and Quality of Life During Endocrine Therapy With Aromatase Inhibitors
- ClinicalTrials.gov ID
- NCT06172088
- Acronym / sponsor ID
- FREE-AI / S00805-NIM
- Keywords
- Fasting, Aromatase Inhibitors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF), Charite University, Berlin, Germany
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 15 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Bicenter, single-arm, prospective intervention study including qualitative accompanying study
| Arm | Type | Receives |
|---|---|---|
| Therapeutic fasting for the reduction of physical of limitations in physical well-being and qol | Experimental | Other: Fasting |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FastingSieben days of online supervised prolonged therapeutic fasting (max. 350 kcal/d). | Other | Therapeutic fasting for the reduction of physical of limitations in physical well-being and qol |
Primary outcome
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.
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.
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.
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).
25 secondary outcomes
World Health Organization's 5
Time frame: After 7 days (end of intervention)
World Health Organization's 5
Time frame: Follow-up 3 Moths after the baseline.
Mindfulness and Awareness Scale
Time frame: After 7 days (end of intervention)
Mindfulness and Awareness Scale
Time frame: Follow-up 3 Moths after the baseline.
Relief of Cancer-related-Fatigue
Time frame: After 7 days (end of intervention)
Relief of Cancer-related-Fatigue
Time frame: Follow-up 3 Moths after the baseline.
Pittsburgh Sleep Quality Index
Time frame: After 7 days (end of intervention)
Pittsburgh Sleep Quality Index
Time frame: Follow-up 3 Moths after the baseline.
Blood pressure
Time frame: After 7 days (end of intervention)
Blood pressure
Time frame: Follow-up 3 Moths after the baseline.
Heart rate
Time frame: After 7 days (end of intervention)
Heart rate
Time frame: Follow-up 3 Moths after the baseline.
Food habits
Time frame: Follow-up 3 Moths after the baseline.
Body-Mass-Index
Time frame: After 7 days (end of intervention)
Body-Mass-Index
Time frame: Follow-up 3 Moths after the baseline.
Abdominal circumference
Time frame: After 7 days (end of intervention)
Abdominal circumference
Time frame: Follow-up 3 Moths after the baseline.
Triglycerides
Time frame: After 7 days (end of intervention)
Triglycerides
Time frame: Follow-up 3 Moths after the baseline.
Gamma-Glutamyl-Transferase
Time frame: After 7 days (end of intervention).
Gamma-Glutamyl-Transferase
Time frame: Follow-up 3 Moths after the baseline.
Fatty Liver Index
Time frame: After 7 days (end of intervention)
Fatty Liver Index
Time frame: Follow-up 3 Moths after the baseline.
Adverse events
Time frame: After 7 days (end of intervention)
Adverse events
Time frame: Follow-up 3 Moths after the baseline.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Derived from this study: PubMed 41805449Meyer H, Koppold DA, Shaker O, Eden L, Schiffmann L, Konigorski S, Cramer H, Choi KA, Einsele H, Winkler M, Loffler C. Therapeutic Fasting as a Novel Approach to Mitigate Musculoskeletal Symptoms in Breast Cancer Patients undergoing Aromatase Inhibitor Therapy: A Feasibility Study Protocol. Integr Cancer Ther. 2026 Jan-Dec;25:15347354261426272. doi: 10.1177/15347354261426272. Epub 2026 Mar 10.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia Loeffler, Dr principal investigator
Wuerzburg University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fasting in people with Breast Cancer Patients Treated With Aromatase Inhibitors, run by University Hospital Tuebingen at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical rating scale (time frame: After 7 days (end of intervention)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06172088, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.