Colon rectal cancer stage I - III MedDRA version: 21.0 Level: LLT Classification code 10001171 Term: Adenocarcinoma of colon stage III System Organ Class: 100000004864 MedDRA version: 21.0 Level: LLT Classification code 10001170 Term: Adenocarcinoma of colon stage II System Organ Class: 100000004864 MedDRA version: 21.0 Level: LLT Classification code 10001169 Term: Adenocarcinoma of colon stage I System Organ Class: 100000004864
Conditions
Interventions
Trade Name: DIBASE - 10.000 UI/ML GOCCE ORALI, SOLUZIONE FLACONE CON GONTACOCCE 10 ML
Product Name: DIBASE
Pharmaceutical Form: Oral drops, solution
Route of administration of the placebo: Oral use
Sponsors
ISTITUTO EUROPEO DI ONCOLOGIA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 35-75 years old patients ; 2. Resected colorectal cancer stage I - III in the last 24 months 3. Signed informed Consent according to ICH-GCP; 4. Willingness to provide stool, blood samples; 5. Performance Status of 0-1 (ECOG); Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 59 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 45
Exclusion criteria
Exclusion criteria: 1. History of cancer in the prior five years (other than CIN and NMSC); 2. Clinical/radiological evidence or laboratory/pathology report of residual neoplasia or recurrence; 3. Carrier of a pathogenetic mutation for the main syndrome for colorectal cancer (FAP, Lynch, other); 4. Vitamin D level = 30 ng/ml; 5. Current daily supplementation of vitamin D (e.g. calcium citrate with vitamin D); 6. History of recurrent renal calculi 7. History of malabsorption syndrome (e.g., pancreatic insufficiency, celiac disease, Crohn disease, any chronic IBD); 8. Chronic liver disease and/or renal disease with alterated biochemical functions, or renal dialysis; = grade 2 based on CTCAE (v 4.0); 9. Pregnancy or breast feeding or planning on becoming pregnant during the study; 10. Known chronic alcoholism; 11. Known hypersensitivity to vitamin D; 12. Any medical condition that in the physician’s opinion would potentially interfere with the subjects’ health.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Change of microbiota profile after 1 year of vitamin D supplementation. ;Secondary Objective: ¿microbiota composition may interact with vitamin D supplementation in changing 25(OH)D serum level. ¿Microbiota and vitamin D status in association with CRC stage and Ki67 expression. ¿VDR, vitamin D binding protein (serum DBP and GC) polymorphism, CYP 27A1 and CYP24A1 polymorphisms and their possible interferences on vitamin D and microbiota interaction. ;Primary end point(s): bacterial composition modification after 1 year of vitamin D administration;Timepoint(s) of evaluation of this end point: at the end of a 12 months treatment period | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): whether Vitamin D receptors, GC and serum level of 25(OH)D, at baseline, are associated with colorectal cancer prognostic factors; whether microbiota composition is associated with colorectal cancer prognostic factors; changes in proliferation evaluated by Ki67 LI on the primary tumor and normal rectal mucosa pre and post treatment; Comparison of lumen and adherent mucosal microbiota composition;Timepoint(s) of evaluation of this end point: 6 months from the end of the treatment of the last patient enrolled ; 6 months from the end of the treatment of the last patient enrolled; 6 months from the end of the treatment of the last patient enrolled; 6 months from the end of the treatment of the last patient enrolled | — |
Countries
Italy
Contacts
Public ContactUfficio studi clinici
Istituto Europeo di Oncologia
Outcome results
None listed