Impact of short-term modified fasting and the combination with a fasting supportive diet during chemotherapy on the incidence and severity of chemotherapy-induced toxicities in cancer patients - a randomised controlled cross-over pilot study
- Conditions
- cancer
- Registration Number
- DRKS00011610
- Lead Sponsor
- niversitätsklinikum Freiburg; Klinik für Innere Medizin I; Sektion Ernährungsmedizin & Diätetik
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 30
Age =18 years, adequate renal function (serum creatinine, urea nitrogen and uric acid), adequate liver function (ALT, AST, ALP, GGT), life expectancy >6 months, minimum of four cycles of the same chemotherapy protocol at a 3- to 4-week interval with all chemotherapeutic drugs administrated in 24 h, written informed consent
Weight loss >5% of body weight in the last 3 months, body mass index <18.5 kg/m2, history of eating disorders (anorexia nervosa, bulimia nervosa or binge eating disorder), patients receiving parenteral nutrition, pregnant or lactating women, serious other diseases such as recent myocardial infarction or clinical signs of cardiac failure, diabetes mellitus undergoing therapy with insulin or oral agents, history of gout or elevated uric acid level, history of syncope with calorie restriction in the past or other medical comorbidity, which would make fasting potentially dangerous, receiving steroids (except dexamethasone given for nausea prevention) or
Receiving concomitant treatment with insulin-like growth factor (IGF)-receptor blockers or monoclonal antibodies targeting the IGF ligands , currently enrolled in a concomitant clinical trial
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Chemotherapy-induced toxicity - the percentage of patients with grade III or higher chemotherapie-induced toxicity graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version (NCI CTCAE) v4.0<br>On day 0 of each chemotherapy cycle and as follow-up 3 weeks after the 4th or 6th cycle<br>
- Secondary Outcome Measures
Name Time Method