Intermittent Fasting Accompanying Chemotherapy in Gynecological Cancers

Not Applicable

Active, not recruiting

• Conditions: Ovarian Cancer; Breast Cancer
• Interventions: Other: Fasting; Other: Vegan

• Registration Number: NCT03162289
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2017-05-10
• Study First Submitted: 2017-05-10
• Study First Submitted QC: 2017-05-18
• Study First Posted: 2017-05-22
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-12
• Last Update Posted: 2022-12-13
• Primary Completion: 2025-06-10
• Study Completion: 2025-06-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

Not provided

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fasting	Fasting	60-72 h-modified fasting (36-48 h before and 24 h after chemotherapy)
Vegan	Vegan	60-72 h-vegan diet (36-48 h before and 24 h after chemotherapy)

Primary Outcome Measures

Name	Time	Method
FACT-G	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

Name	Time	Method
Complete remissions	From date of randomization until the date of surgery	Number of histologically proven complete remissions (ypT0ypN0 bzw. ypT0/is) after neoadjuvant CT
Millar Payne classification	after surgery/histological examination, an average 6 months after intervention start	Histological classification according to Millar Payne scale

Trial Locations

Locations (8)

Ernst-von-Bergmann Klinikum, Klinik für Gynäkologie und Geburtshilfe; 🇩🇪 Potsdam, Brandenburg, Germany

Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus; 🇩🇪 Berlin, Germany

Brustzentrum Charite Campus Mitte; 🇩🇪 Berlin, Germany

Vivantes Brustzentrum; 🇩🇪 Berlin, Germany

Klinikum Ludwigsburg; 🇩🇪 Ludwigsburg, Baden-Württemberg, Germany

Charité Virchow Klinikum; 🇩🇪 Berlin, Germany

Albert-Ludwigs-University of Freiburg; 🇩🇪 Freiburg im Breisgau, Baden-Württemberg, Germany

Brustzentrum Krankenhaus Waldfriede; 🇩🇪 Berlin, Germany