C18 C19 C20
Conditions
Interventions
Group 1: The intervention group will receive a commercially available probiotic and prebiotic preparation for daily use for 12 weeks, i.e. 84 days, starting on the first day after surgery at which ora
Sponsors
Deutsches Krebsforschungszentrum (DKFZ)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Diagnosis of colorectal cancer (ICD-10: C18-C20, any stage) • Planned colorectal cancer resection in one of the 10 cooperating German hospitals within the next 14 days • Willingness to complete the pre-surgery questionnaire and to provide the first blood and stool sample or rectal swab before the surgery • Informed consent to participate in the LEONORA trial
Exclusion criteria
Exclusion criteria: • Patient with any social or logistical condition, which in the opinion of the investigator may interfere with the conduct of the study, such as incapacity to well understand, not willing to collaborate, or cannot easily be contacted after discharge • Previous participation in this study • Parallel participation in another interventional trial with a nutritional intervention • Pregnant women • Use of immunosuppressants (systemic glucocorticoids with a daily dosis of more than 10 mg prednisolone (or equivalent) or drugs of ATC group L04A, except adjuvant chemotherapy or radiotherapy for colorectal cancer treatment) • Insulin-dependent diabetes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gastrointestinal quality of life (assessed by the Gastrointestinal Quality of Life Index (GIQLI) questionnaire) | — |
Secondary
| Measure | Time frame |
|---|---|
| • GIQLI subscales for symptoms (e.g. diarrhea, flatulence and obstipation), physical, emotional and social function • Low Anterior Resection Syndrome (LARS) • Further quality of life total and sub-scales (EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-CR29) • Fatigue scale (EORTC QLQ-FA12) • Anxiety (GAD-7) • Depression (CESD-R) • Cost-effectiveness (costs per prevented diarrhea case) and cost-utility (costs per quality adjusted life-year gained) • Emergence of multiple drug resistant organisms • Rate of physician-documented infections (bloodstream infection (BSI), catheter-related BSI, pneumonia, surgical site infections, intra-abdominal infections, and urinary-tract infections). • Rate of self-reported infections (upper and lower respiratory tract infections, gastro-intestinal tract infections, bladder infections, wound infections, other infections and episodes with high fever (=38°C)). • Total rate of infections. • Antibiotics use (No, yes and number of days). • Rates of post-operative complications (2nd initiation of antibiotic or antifungal treatment, sepsis surgical revision, new mechanical ventilation or death) • Time from surgery to hospital discharge • Number and length of hospitalizations • Changes in the gut microbiome composition • Serum biomarkers of inflammation and immune function • Serum and stool biomarkers of metabolism related to the gut microbiome (amino acids, fatty acids, and bile acids) • Overall survival, disease-free survival, and progression-free survival | — |
Countries
Germany
Contacts
Public ContactBen Schöttker
Deutsches Krebsforschungszentrum (DKFZ)
Outcome results
None listed