Intermittent Fasting Accompanying Chemotherapy in Gynecological Cancers (FIT2)

December 12, 2022 updated by: Andreas Michalsen, Charite University, Berlin, Germany

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Brustzentrum Charite Campus Mitte
      • Berlin, Germany, 10967
        • Vivantes Brustzentrum
      • Berlin, Germany, 13353
        • Charité Virchow Klinikum
      • Berlin, Germany, 14163
        • Brustzentrum Krankenhaus Waldfriede
      • Berlin, Germany, 14163
        • Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus
    • Baden-Württemberg
      • Freiburg im Breisgau, Baden-Württemberg, Germany, 79085
        • Albert-Ludwigs-University of Freiburg
      • Ludwigsburg, Baden-Württemberg, Germany, 71640
        • Klinikum Ludwigsburg
    • Brandenburg
      • Potsdam, Brandenburg, Germany, 14467
        • Ernst-von-Bergmann Klinikum, Klinik für Gynäkologie und Geburtshilfe

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Diagnosed, gynecological, malignant tumor disease (non-metastatic ovarian or breast cancer).

Other inclusion criteria:

  • Age 18-75 years
  • Cancer is treated conventionally with an adjuvant or neo-adjuvant protocol with at least 4 CT cycles

The following CTs are considered for breast carcinoma:

  • - (EC, Sparano) 4 x Epirubicin and Cyclophosphamide, followed by 12 cycles Paclitaxel weekly
  • - (AC, Henderson) 4 x Doxorubicin, cyclophosphamide, followed by 4 cycles Docetaxel every three weeks

If the recruitment rate is not reached, further CT protocols can be accepted.

CT for patients with ovarian cancer: According to current protocols, at least 4 planned cycles. For the study a maximum of 8 cycles are considered (except therapy with Taxol).

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Fasting
60-72 h-modified fasting (36-48 h before and 24 h after chemotherapy)
Other: Fasting
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.
Active Comparator: Vegan
60-72 h-vegan diet (36-48 h before and 24 h after chemotherapy)
Other: Vegan
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Complete remissions
Time Frame: From date of randomization until the date of surgery
Number of histologically proven complete remissions (ypT0ypN0 bzw. ypT0/is) after neoadjuvant CT
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
Histological classification according to Millar Payne scale
after surgery/histological examination, an average 6 months after intervention start

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Trial outcome index score (TOI)
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
TOI
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
Total AC (FACT-B/FACT-O)
Time Frame: Date of inclusion (baseline), day -2 and +7 at each 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
According to kind of cancer (breast cancer/ ovarian cancer)
Date of inclusion (baseline), day -2 and +7 at each 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
FACIT-F
Time Frame: Date of inclusion (baseline), day -2 and +7 at each 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
Fatigue
Date of inclusion (baseline), day -2 and +7 at each 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
FACT-Tax,FACT/GynecologicOncologyGroup-Ntx
Time Frame: Date of inclusion (baseline), day -2 and +7 at each 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
Specific chemotherapy induced effects on quality of life and neurologic symptoms
Date of inclusion (baseline), day -2 and +7 at each 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
Chemotherapy-Induced Peripheral Neuropathy Assessment Tool
Time Frame: Date of inclusion (baseline), day -2 and +7 at each 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
Chemotherapy-Induced Peripheral Neuropathy Assessment Tool
Date of inclusion (baseline), day -2 and +7 at each 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
Hospital Anxiety and Depression Scale
Time Frame: Date of inclusion (baseline), day -2 and +7 at each 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
Hospital Anxiety and Depression Scale
Date of inclusion (baseline), day -2 and +7 at each 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
Side effects of CT
Time Frame: Date of inclusion (baseline), day -2 and +7 at each 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
Likert scales
Date of inclusion (baseline), day -2 and +7 at each 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
Weight
Time Frame: Timing varies according to individual therapy plan, Date of inclusion (baseline) and up to 3 years after inclusion
Documentation according to the standard documentation rules of the German Tumour Centres Work Group, Weight in kilograms
Timing varies according to individual therapy plan, Date of inclusion (baseline) and up to 3 years after inclusion
BMI
Time Frame: Timing varies according to individual therapy plan, Date of inclusion (baseline) and up to 3 years after inclusion
Documentation according to the standard documentation rules of the German Tumour Centres Work Group, BMI in kg/m^2
Timing varies according to individual therapy plan, Date of inclusion (baseline) and up to 3 years after inclusion
Blood panel
Time Frame: Timing varies according to individual therapy plan, Date of inclusion (baseline) and up to 3 years after inclusion
Documentation according to the standard documentation rules of the German Tumour Centres Work Group, units auf measure according to SI units
Timing varies according to individual therapy plan, Date of inclusion (baseline) and up to 3 years after inclusion
Blood values for liver function
Time Frame: Timing varies according to individual therapy plan, Date of inclusion (baseline) and up to 3 years after inclusion
Documentation according to the standard documentation rules of the German Tumour Centres Work Group, units auf measure according to SI units
Timing varies according to individual therapy plan, Date of inclusion (baseline) and up to 3 years after inclusion
Blood values for renal function (Krea, Hst.)
Time Frame: Timing varies according to individual therapy plan, Date of inclusion (baseline) and up to 3 years after inclusion
Documentation according to the standard documentation rules of the German Tumour Centres Work Group, units auf measure according to SI units
Timing varies according to individual therapy plan, Date of inclusion (baseline) and up to 3 years after inclusion
IGF-1, Insulin, Blood glucose
Time Frame: Baseline, after 4 months and before each of the first 4 CTs meaning approx week 1,4,7 and 10 after intervention start
Explorative measurements in blood samples in subgroup of 20 patients
Baseline, after 4 months and before each of the first 4 CTs meaning approx week 1,4,7 and 10 after intervention start
Long-term explorative measurements: frequency of recurrence
Time Frame: 1, 2 and 3 years after baseline
Information taken from the documentation of the treatment, visits and questionnaires
1, 2 and 3 years after baseline
Long-term explorative measurements: e.g. polyneuropathy, cardiomyopathy
Time Frame: 1, 2 and 3 years after baseline
Information taken from the documentation of the treatment, visits, questionnaires and interview
1, 2 and 3 years after baseline
ketone bodies
Time Frame: Baseline, after 4 months and before each of the first 4 CTs meaning approx week 1,4,7 and 10 after intervention start
Explorative measurements in capillary blood, only in subpopulation of n=20
Baseline, after 4 months and before each of the first 4 CTs meaning approx week 1,4,7 and 10 after intervention start
Elective items of the "Common Terminology Criteria for Adverse Events (CTCAE)
Time Frame: Baseline, 3 weeks after end of CT, 1,2,3 years after baseline
Elective items of the "Common Terminology Criteria for Adverse Events (CTCAE)"
Baseline, 3 weeks after end of CT, 1,2,3 years after baseline
Qualitative interviews in focus groups
Time Frame: Baseline, 6 months
Qualitative interviews in focus groups
Baseline, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Charite University, Berlin, Germany

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Andreas Michalsen, Prof. Dr., Study Principal Investigator Charite

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 10, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 10, 2025

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 10, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 10, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 18, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 22, 2017

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 13, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FIT 2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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