Intermittent Fasting Accompanying Chemotherapy in Gynecological Cancers

  • STATUS
    Recruiting
  • End date
    Jun 10, 2022
  • participants needed
    150
  • sponsor
    Charite University, Berlin, Germany
Updated on 23 January 2021
paclitaxel
cyclophosphamide
carcinoma
breast cancer
doxorubicin
docetaxel
cancer chemotherapy
breast carcinoma
epirubicin
immunostimulant
taxol
cancer of the ovary

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.

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.

Details
Condition Ovarian disorder, Breast Cancer, Ovarian Cancer, Ovarian Function, Breast Cancer Diagnosis, Recurrent Ovarian Cancer, breast carcinoma, ovarian carcinomas, cancer, ovarian, cancer ovarian, cancer of the ovary, cancer, breast, ovarian tumors
Treatment Fasting, Vegan, Vegan, Diet as usual
Clinical Study IdentifierNCT03162289
SponsorCharite University, Berlin, Germany
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 75 yrs?
Are you female?
Do you have any of these conditions: Ovarian Cancer or Breast Cancer?
Do you have any of these conditions: Ovarian Function or Recurrent Ovarian Cancer or cancer ovarian or ovarian tumors or Breast Cancer Diagnosis or cancer of the ovary or Breast Cancer or...?
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
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
Renal insufficiency (creatinine> 2mg / dl)
Pre-existing eating disorder (Anorexia nervosa, Bulimia)
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)
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