K59.9
Conditions
Interventions
Group 1: Nutritonial counselling focussing prebiotic and high fibre nutrition + probiotic supplement
Group 2: Nutritonial counselling focussing prebiotic and high fibre nutrition + placebo
Sponsors
Universitäres Cancer Center Hamburg (UCCH) - Hubertus Wald Tumorzentrum
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - patients after bowel cancer disease with gastrointestinal symptoms - 3 months to 5 years after cessation of cancer treatment - expectancy > 6 months - full-aged - written informed consent
Exclusion criteria
Exclusion criteria: - active infections > level 2 NCI-CTCAE V5.0 - severe systemic disease such as uncontrolled hypertension, heart failure or uncorntolled hyperglycaemia - course of antibiotics in the past 8 weeks - uncontrolled diabetes type 1 or 2 - immunosuppressive therapy, slow-healing wounds, ulcers, bone fractures - pregnant women or those wishing to become pregnant as well as patients who do not apply contraceptive methods - all conditions that could possibly compromise study outcome or patients safety - all familial, psychologial or socialogical conditions that do not comply with the protocol - participation in a study with an investigational product in the last 15 days before inclusion - incarcerated patients - enteral supplementation or parenteral nutrition or sip feeds (when covering over 50% of energy demand) after therapy of tumor cachexia - presence of intestinal stenosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| gastrointestinal symptoms (difference 12 weeks after baseline) measured by EORTC-C30 /C29) | — |
Secondary
| Measure | Time frame |
|---|---|
| - microbiota determination (through 16S rRNA gene analysis) of the stool and a coloscopically extracted sample from the aftercare coloscopy - Nutritional behaviour and assessment of the fibre intake (24h-recall) - stool frequency and stool consistency + further gastrointextinal symptoms through anamnesis and bristol stool scale - biochemical parameter: liver and kidney function readings, CRP, cytokine (e.g. Interleukin-6 and TNF-alpha) - recurrence free survival and overall survival - assessment of quality of life and disease related symptoms through EORTC-C30/C29 - adherence of probiotics intake - weight | — |
Countries
Germany
Contacts
Public ContactJulia von Grundherr
Universitäres Cancer Center Hamburg (UCCH)Hubertus Wald Tumorzentrum
Outcome results
None listed