Breast CancerFIT2NCT03162289
Intermittent Fasting Accompanying Chemotherapy in Gynecological Cancers
A study testing Fasting and Vegan in people with Breast Cancer and Ovarian Cancer, run by Charite University, Berlin, Germany at 8 sites in Germany.
Trial summary
The aim of this trial is an evaluation of the effectiveness of intermittent fasting as a supplementary therapy in patients with breast cancer and ovarian cancer in respect to quality of life, reduction of side effects and possible reduction in tumor progression. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer, Ovarian Cancer
- What is being tested?
- Fasting and Vegan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 8 sitesGermany
- Study dates
- 10 May 2017to 10 Jun 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Reduction in CT dose compared to usual dosage
- Excessive underweight (BMI <19kg / m2) or actual weight reduction > 3kg or > 5kg in the last 1 or 3 months.
- Pre-existing eating disorder (Anorexia nervosa, Bulimia)
- Renal insufficiency (creatinine> 2mg / dl)
- Severe disease or other disease with a significant reduction in mobility and overall vitality
- Diabetes mellitus
- No inclusion in other study protocol
- Lack of email address and Internet access (due to electronic CRF)
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Germany8 sites
Brustzentrum Charite Campus Mitte
Berlin, 10117
Vivantes Brustzentrum
Berlin, 10967
Charité Virchow Klinikum
Berlin, 13353
Brustzentrum Krankenhaus Waldfriede
Berlin, 14163
Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus
Berlin, 14163
Albert-Ludwigs-University of Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, 79085
Klinikum Ludwigsburg
Ludwigsburg, Baden-Wurttemberg, 71640
Ernst-von-Bergmann Klinikum, Klinik für Gynäkologie und Geburtshilfe
Potsdam, Brandenburg, 14467
About this study
Official title: Intermittent Fasting Accompanying Chemotherapy in Gynecological Cancers - a Randomized, Controlled, Two-armed Intervention Study
The aim of this trial is an evaluation of the effectiveness of intermittent fasting as a supplementary therapy in patients with breast cancer and ovarian cancer in respect to quality of life, reduction of side effects and possible reduction in tumor progression.
Read the detailed description
Chemotherapy (CT) is a basic element in the therapy of gynecological oncologic diseases besides surgery, antibody therapy, anti-hormonal therapy and radiation. The chemotherapeutic intervention can be experienced physically and psychologically as a severe stress due to unwanted acute and also relevant long term side effects. It is even possible that because of severe side effects the CT can not be continued and main goals of the therapy like tumor reduction or elimination can not be achieved. Except of some medicinal approaches (such as antiemetics) or therapeutic exercise, not many therapeutic approaches are known to help reduce CT induced side effects. Against this background it is important to identify and scientifically evaluate new approaches to reduce the side effects of CT. The aim of this study is to verify the effectiveness of intermittent fasting as a potentially helpful supportive therapy in CT. In a prior pilot study of our institute with 34 breast- and ovarian cancer patients showed beneficial effects of an intermittent fasting of 72-84 h parallel to the application of the CT (manuscript submitted in Cancer Science).
The results of this confirmatory study are therefore of potentially high clinical relevance for all chemotherapeutically treated patients.
Long term goal: This study can lead to the improvement of tolerance and effectiveness of chemotherapeutic tumor therapy through accompanying intense nutritional therapy interventions. Beyond that it can be the starting point of a following multi-center randomized controlled study.
A large variety of animal experimental studies as well as three smaller pilot studies suggest that intermittent fasting can reduce the unwanted side effects of CT and enhance the quality of life. It is being speculated that the anti-tumor effect of fasting is enhanced through the reduction of the Insulin-like growth factor-1 (IGF-1) and mTOR as well as p53-signalling molecules (differential stress resistance).
But it is still unclear whether the possible beneficial effect that intermittent fasting shows can only be reached by subtotal caloric restriction or a significant reduction of the intake of animal proteins and refined sugar could also cause a similar decrease in IGF-1.
Against this background this confirmatory study aims to test the hypothesis that CT in the adjuvant and neoadjuvant treatment of breast- and ovarian cancer is better tolerable under intermittent fasting than under a normo-caloric vegan and sugar-reduced diet.
- Conditions
- Breast Cancer, Ovarian Cancer
- Being tested
- Fasting, Vegan
- Keywords
- Fasting, Vegan
- Medical subject headings
- Breast Neoplasms, Ovarian Neoplasms, Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FastingOther
Patients follow a modified fasting regime of 60-72 h (36-48 h before and 24 h after CT) with a dietary energy supply of 350-400kcal per day with vegetable juices during the first four cycles of CT. During the rest of the CT cycles they will observe two days of caloric restriction (24 h before and after CT). Between CTs a mainly vegetarian diet will be performed and the patients are encouraged to follow a pattern of time restricted feeding with 14 h fasting over night at least for six days a week. The patients will receive an individual nutrition training by trained nutritionists.
VeganOther
Patients follow a 60-72 h vegan diet with sugar restriction (36-48 h before and 24 h after CT) during the first four cycles of CT. During the rest of the CT cycles they will observe two days of vegan and sugar-restricted diet (24 h before and after CT). Between CTs a mainly vegetarian diet will be performed. The patients will receive an individual nutrition training by trained nutritionists.
| Study group | Role | What they receive |
|---|---|---|
| Fasting | Active comparator | 60-72 h-modified fasting (36-48 h before and 24 h after chemotherapy) Receives: Other: Fasting |
| Vegan | Active comparator | 60-72 h-vegan diet (36-48 h before and 24 h after chemotherapy) Receives: Other: Vegan |
What is being measured
The primary outcome is the main question the study is designed to answer.
FACT-G
Summarized change of FACT-G score
Measured: Date of inclusion (baseline), day -2 and +7 at each chemotherapy (CT) in triweekly cycles/-2 days at each CT in weekly cycles and +7 after the last weekly CT, 4 months after inclusion, 3 weeks after end of CT and 1, 2 and 3 years after inclusion
Secondary outcomes (2)
Complete remissions
Number of histologically proven complete remissions (ypT0ypN0 bzw. ypT0/is) after neoadjuvant CT
Measured: From date of randomization until the date of surgery
Millar Payne classification
Histological classification according to Millar Payne scale
Measured: after surgery/histological examination, an average 6 months after intervention start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2017
- Study start10 May 2017
- Primary completion10 Jun 2025 (estimated)
- Study completion10 Jun 2025 (estimated)
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 CancerStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andreas Michalsen, Charite University, Berlin, Germany
- Investigators
- Andreas Michalsen, Prof. Dr., Principal investigator, Study Principal Investigator Charite
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03162289
- Sponsor's protocol ID
- FIT 2
- Acronym
- FIT2
- Status last verified
- Dec 2022
- First submitted
- 10 May 2017
- Last updated
- 13 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Koppold-Liebscher D, Kessler CS, Steckhan N, Bahr V, Kempter C, Wischnewsky M, Hubner M, Kunz B, Paul M, Zorn S, Sari S, Jeitler M, Stange R, Michalsen A. Short-term fasting accompanying chemotherapy as a supportive therapy in gynecological cancer: protocol for a multicenter randomized controlled clinical trial. Trials. 2020 Oct 15;21(1):854. doi: 10.1186/s13063-020-04700-9.
PubMed 33059765
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermittent Fasting Accompanying Chemotherapy in Gynecological Cancers - a Randomized, Controlled, Two-armed Intervention Study
- ClinicalTrials.gov ID
- NCT03162289
- Acronym / sponsor ID
- FIT2 / FIT 2
- Conditions
- Breast Cancer, Ovarian Cancer
- Keywords
- Fasting, Vegan
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 10 May 2017 (actual)
- Primary completion
- 10 Jun 2025 (estimated)
- Study completion
- 10 Jun 2025 (estimated)
- First posted
- 22 May 2017 (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.
The aim of this trial is an evaluation of the effectiveness of intermittent fasting as a supplementary therapy in patients with breast cancer and ovarian cancer in respect to quality of life, reduction of side effects and possible reduction in tumor progression.
Detailed description
Chemotherapy (CT) is a basic element in the therapy of gynecological oncologic diseases besides surgery, antibody therapy, anti-hormonal therapy and radiation. The chemotherapeutic intervention can be experienced physically and psychologically as a severe stress due to unwanted acute and also relevant long term side effects. It is even possible that because of severe side effects the CT can not be continued and main goals of the therapy like tumor reduction or elimination can not be achieved. Except of some medicinal approaches (such as antiemetics) or therapeutic exercise, not many therapeutic approaches are known to help reduce CT induced side effects. Against this background it is important to identify and scientifically evaluate new approaches to reduce the side effects of CT. The aim of this study is to verify the effectiveness of intermittent fasting as a potentially helpful supportive therapy in CT. In a prior pilot study of our institute with 34 breast- and ovarian cancer patients showed beneficial effects of an intermittent fasting of 72-84 h parallel to the application of the CT (manuscript submitted in Cancer Science).
The results of this confirmatory study are therefore of potentially high clinical relevance for all chemotherapeutically treated patients.
Long term goal: This study can lead to the improvement of tolerance and effectiveness of chemotherapeutic tumor therapy through accompanying intense nutritional therapy interventions. Beyond that it can be the starting point of a following multi-center randomized controlled study.
A large variety of animal experimental studies as well as three smaller pilot studies suggest that intermittent fasting can reduce the unwanted side effects of CT and enhance the quality of life. It is being speculated that the anti-tumor effect of fasting is enhanced through the reduction of the Insulin-like growth factor-1 (IGF-1) and mTOR as well as p53-signalling molecules (differential stress resistance).
But it is still unclear whether the possible beneficial effect that intermittent fasting shows can only be reached by subtotal caloric restriction or a significant reduction of the intake of animal proteins and refined sugar could also cause a similar decrease in IGF-1.
Against this background this confirmatory study aims to test the hypothesis that CT in the adjuvant and neoadjuvant treatment of breast- and ovarian cancer is better tolerable under intermittent fasting than under a normo-caloric vegan and sugar-reduced diet.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fasting | Active comparator | Other: Fasting60-72 h-modified fasting (36-48 h before and 24 h after chemotherapy) |
| Vegan | Active comparator | Other: Vegan60-72 h-vegan diet (36-48 h before and 24 h after chemotherapy) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (8 listed)
- Reduction in CT dose compared to usual dosage
- Excessive underweight (BMI <19kg / m2) or actual weight reduction > 3kg or > 5kg in the last 1 or 3 months.
- Pre-existing eating disorder (Anorexia nervosa, Bulimia)
- Renal insufficiency (creatinine> 2mg / dl)
- Severe disease or other disease with a significant reduction in mobility and overall vitality
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 |
|---|---|---|
| FastingPatients follow a modified fasting regime of 60-72 h (36-48 h before and 24 h after CT) with a dietary energy supply of 350-400kcal per day with vegetable juices during the first four cycles of CT. During the rest of the CT cycles they will observe two days of caloric restriction (24 h before and after CT). Between CTs a mainly vegetarian diet will be performed and the patients are encouraged to follow a pattern of time restricted feeding with 14 h fasting over night at least for six days a week. The patients will receive an individual nutrition training by trained nutritionists. | Other | Fasting |
| VeganPatients follow a 60-72 h vegan diet with sugar restriction (36-48 h before and 24 h after CT) during the first four cycles of CT. During the rest of the CT cycles they will observe two days of vegan and sugar-restricted diet (24 h before and after CT). Between CTs a mainly vegetarian diet will be performed. The patients will receive an individual nutrition training by trained nutritionists. | Other | Vegan |
Primary outcome
FACT-G
Time frame: Date of inclusion (baseline), day -2 and +7 at each chemotherapy (CT) in triweekly cycles/-2 days at each CT in weekly cycles and +7 after the last weekly CT, 4 months after inclusion, 3 weeks after end of CT and 1, 2 and 3 years after inclusion
Summarized change of FACT-G score
2 secondary outcomes
Complete remissions
Time frame: From date of randomization until the date of surgery
Millar Payne classification
Time frame: after surgery/histological examination, an average 6 months after intervention start
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2022.
- Derived from this study: PubMed 33059765Koppold-Liebscher D, Kessler CS, Steckhan N, Bahr V, Kempter C, Wischnewsky M, Hubner M, Kunz B, Paul M, Zorn S, Sari S, Jeitler M, Stange R, Michalsen A. Short-term fasting accompanying chemotherapy as a supportive therapy in gynecological cancer: protocol for a multicenter randomized controlled clinical trial. Trials. 2020 Oct 15;21(1):854. doi: 10.1186/s13063-020-04700-9.
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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.
Andreas Michalsen, Prof. Dr. principal investigator
Study Principal Investigator Charite
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fasting and Vegan in people with Breast Cancer and Ovarian Cancer, run by Charite University, Berlin, Germany at 8 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 0 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 13 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
Results are not available in the source record.
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?
FACT-G (time frame: Date of inclusion (baseline), day -2 and +7 at each chemotherapy (CT) in triweekly cycles/-2 days at each CT in weekly cycles and +7 after the last weekly CT, 4 months after inclusion, 3 weeks after end of CT and 1, 2 and 3 years after inclusion). 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 NCT03162289, 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 13 Dec 2022.