Effects of intermittent fasting on quality of life and toleance of chemotherapy in patients with gynaecological cancers: a randomized-controlled multi-center study

Phase 3

Recruiting

• Conditions: C50; C56; C54.1; C53; Malignant neoplasm of breast; Malignant neoplasm of ovary; Endometrium; Malignant neoplasm of cervix uteri

• Registration Number: DRKS00031429
• Lead Sponsor: Klinik und Poliklinik für Geburtshilfe und Frauengesundheit der Universitätsmedizin Mainz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-08
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 110

Inclusion Criteria

Gynaecological cancers (ovarian/endometrial/cervical/breast)
- BMI = 19 kg/m2
- Baseline ECOG Status 0-2
- Life expactancy of over 6 months
- No i.v. chemotherapy in last 3 months
- Planned to recieve chemotherapy with at least one topoisomeraseinhibitor or alkylating agent over a period of three months
- Ability to understand the meaning and effects of the trial

Exclusion Criteria

- Simultaneaos radiationtherapy
- Weight loss of >10% in last 6 months
- Diabetes mellitus Typ I or badly managed other type
- Liver or renal failure
- Akute psychiatric diseases
- Myocardial infarction in past 3 months or instable heart disease
- Stroke or lung artery embolism in past 3 months
- Pregnancy or breastfeeding period
- Severe internal medicine comorbidities
- Enterostoma or short bowl syndrom
- Current or past eating disorders

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in fatigue measured by the FACIT-FS questionnaire during 3 months of chemotherapy. The questionnaire will be assessed weekly to evaluate changes in fatigue during the chemotherapy cycle.