C50 C56 C54.1 C53
Conditions
Interventions
Group 1: Intermittent fasting (16:8h) over a period of three months during chemotherapie, has to be performed at at least 5 of 7 days per week, no food intake allowed on day of chemotherapy
Group 2: N
Sponsors
Klinik und Poliklinik für Geburtshilfe und Frauengesundheit der Universitätsmedizin Mainz
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary, explorative clinical endpoints: - General Quality of Life: measured by the FACT-G questionnaire and tumorspecific FACT questionnaires, as well as the general wellbeing questions of the EORTC QLQ C30 questionnaire; weekly recording of changes - Sleep Quality: measured by the Pittsburgh Sleep Quality Index, recorded at baseline, 3 months and 6 months - Pelvic floor function: measured by the German pelvic floor questionnaire, recorded at baseline, 3 months and 6 months - Chemotherapy associated side effects: measured by CTCAE criteria, recorded at every cycle - Weight changes: measured by body weight every cycle - Laboratory changes (metabolic and organ function): measurment of different values at different time points, blood draws weekly - Tumor response: tumormarker every 3 months, radiological tumor response measured by RECIST 1.1 every 3 months in metastasized patients, pathological tumor response post-surgery in neoadjuvantly treated patients Secondary, explorative laboratory endpoints: - Changes in immunological cells: Composition of peripheral blood mononuclear cells at baslien, 7 weeks and 13 weeks - Peripheral cell damage: measured by yH2AX intensity 3h after the start of chemotherapy at cylce 1, 6 weeks and 12 weeks | — |
Countries
Germany
Contacts
Public ContactMona Schmidt
Klinik und Poliklinik für Geburtshilfe und Frauengesundheit der Universitätsmedizin Mainz
Outcome results
None listed