cancer
Conditions
Interventions
Group 1: F = 4-day fasting period during 2 to 3 cycles of chemotherapy followed by NC (normal diet period, normocaloric) during the next 2 to 3 cycles of chemotherapy
Group 2: FAD+F = 10-day dietary i
Sponsors
Universitätsklinikum Freiburg; Klinik für Innere Medizin I; Sektion Ernährungsmedizin & Diätetik
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 On day 0 of each chemotherapy cycle and as follow-up 3 weeks after the 4th or 6th cycle | — |
Secondary
| Measure | Time frame |
|---|---|
| nutritional status (body weight, height and SGA questionnaire) Body composition (fat-free mass, body cell mass, phase angle) with a mobile multifrequency device (Nutrigard MS™, Data Input GmbH, Darmstadt, Germany) quality of life (QLQ–C30 questionnaire v.3.0 combined with the breast cancer module EORTC QLQ-BR23 v1.0) chemotherapy-induced polyneuropathy (QLQ-CIPN20) Laboratory values: Glucose, Growth factor (insulin, insulin-like growth factor), Thyroid hormone (TSH, FT3, FT4), Blood count Further Laboratory values: Liver function (bilirubin, ALT, AST, ALP, GGT) Renal function (creatinine , urea nitrogen, uric acid) Electrolytes (sodium, potassium, calcium, magnesium) (Institute of Clinical Chemistry and Laboratory Medicine at University Medical Centre Freiburg) metabolic parameters: Ketone bodies (urine) Reagent strips for self-testing of urinary acetoacetate (Ketostix®, Bayer AG, Switzerland) Ketone bodies (blood): Testing device with blood ß-ketone test strips (FreeStyle Precision Neo(TM) Blood Glucose and Ketone Monitoring System, Abbott GmbH & Co. KG, Germany) TM Dietary record: Dietary intake (energy intake, macro-nutrient composition) analysed by professional software (PRODI® expert, Nutri-Science GmbH, Germany) All data will be collected on day 0 of each chemotherapy cycle and as follow-up 3 weeks after the 4th or 6th cycle | — |
Countries
Germany
Contacts
Public ContactAnna Raynor
Universitätsklinikum Freiburg - Klinik für Innere Medizin ISektion Ernährungsmedizin & Diätetik
Outcome results
None listed