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Intermittent Fasting Accompanying Chemotherapy in Gynecological Cancers (FIT2)

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ClinicalTrials.gov Identifier: NCT03162289
Recruitment Status : Recruiting
First Posted : May 22, 2017
Last Update Posted : October 24, 2019
Sponsor:
Information provided by (Responsible Party):
Andreas Michalsen, Charite University, Berlin, Germany

Brief 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Ovarian Cancer Other: Fasting Other: Vegan Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Intermittent Fasting Accompanying Chemotherapy in Gynecological Cancers - a Randomized, Controlled, Two-armed Intervention Study
Actual Study Start Date : May 10, 2017
Estimated Primary Completion Date : June 10, 2021
Estimated Study Completion Date : June 10, 2022


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. Millar Payne classification [ Time Frame: after surgery/histological examination, an average 6 months after intervention start ]
    Histological classification according to Millar Payne scale


Other Outcome Measures:
  1. 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

  2. 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)

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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)"

  18. Qualitative interviews in focus groups [ Time Frame: Baseline, 6 months ]
    Qualitative interviews in focus groups



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03162289


Contacts
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Contact: Andreas Michalsan, Prof. Dr. +49 30 80505 691 a.michalsen@immanuel.de

Locations
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Germany
Albert-Ludwigs-University of Freiburg Recruiting
Freiburg im Breisgau, Baden-Württemberg, Germany, 79085
Contact: Stephanie Zorn    +49 761 270-33600    stefanie.zorn@uniklinik-freiburg.de   
Klinikum Ludwigsburg Recruiting
Ludwigsburg, Baden-Württemberg, Germany, 71640
Contact: Hänle Claudia, Dr.    07141 99 63296    claudia.haenle@kliniken-lb.de   
Ernst-von-Bergmann Klinikum, Klinik für Gynäkologie und Geburtshilfe Recruiting
Potsdam, Brandenburg, Germany, 14467
Contact: Fischer, Dr.    0331 241 - 3 5602    dfischer@klinikumevb.de   
Brustzentrum Charite Campus Mitte Not yet recruiting
Berlin, Germany, 10117
Contact: Blohmer, Prof. Dr.    +49 30 450 564 172    frauenklinik-mitte@charite.de   
Vivantes Brustzentrum Recruiting
Berlin, Germany, 10967
Contact: Marion Paul, Dr.    +49.30.130.222048    marion.paul@vivantes.de   
Charité Virchow Klinikum Not yet recruiting
Berlin, Germany, 13353
Contact: Jalid Sehouli, Prof. Dr.    +49 30 450 564 002    Jalid.Sehouli@charite.de   
Brustzentrum Krankenhaus Waldfriede Recruiting
Berlin, Germany, 14163
Contact: Cornelia Kempter, Dr.    +49-30-81810-145    Brustzentrum@waldfriede.de   
Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus Recruiting
Berlin, Germany, 14163
Contact: Andreas Michalsen, Prof. Dr.    +49 (0)30 - 80505 - 691    a.michalsen@immanuel.de   
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
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Principal Investigator: Andreas Michalsen, Prof. Dr. Study Principal Investigator Charite
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Responsible Party: Andreas Michalsen, Principal Investigator, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT03162289    
Other Study ID Numbers: FIT 2
First Posted: May 22, 2017    Key Record Dates
Last Update Posted: October 24, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Andreas Michalsen, Charite University, Berlin, Germany:
Fasting
Vegan