Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00197873
Status:
COMPLETED
Last Update Posted:
2021-11-24
First Post:
2005-09-12
Brief Title:
Lactobacillus Rhamnosus in Prevention of Chemotherapy-related Diarrhoea
Sponsor:
University of Helsinki
Organization:
University of Helsinki
Study Overview
Official Title:
Randomized Double Blind Placebo Controlled Cross-over Phase II Study on the Effects of Lactobacillus Rhamnosus GG Supplementation in Patients on 1st Line XELOXA Treatment for Metastatic Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2021-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Chemotherapy may cause diarrhoea which may be associated with treatment delay and infections The purpose of the study is to investigate whether oral supplementation with lactobacilli will alleviate chemotherapy related diarrhoea Patients diagnosed with advanced colorectal cancer and who will receive chemotherapy will be randomly assigned to receive either lactobacilli or placebo during chemotherapy The study is a prospective multicenter randomized double-blind placebo-controlled study The primary outcome measure is frequency of moderatesevere diarrhoea The study will also address safety and tolerability of chemotherapy response to chemotherapy and serum growth factor levels
Detailed Description:
This is a prospective multicenter randomized cross-over double-blind placebo-controlled study Patients diagnosed with advanced colorectal cancer with overt distant metastases and who will receive chemotherapy consisting of capecitabine oxaliplatin and bevacizumab given as 3-weekly cycles will be randomly assigned to receive either lactobacilli GefilusR or placebo during the first 3 cycles of chemotherapy for 9 weeks Following this the groups will be crossed over and those study participants who were allocated to lactobacilli will receive placebo for 9 weeks and vice versa Lactobacilli and placebo are administered twice daily The total daily dose of lactobacilli is 20 billion CFU The primary outcome measure is frequency of moderatesevere diarrhoea grade 2-4 Adverse effects including the frequency of diarrhoea flatulence bloating constipation and nausea will be longitudinally monitored based on a patient diary and study visits The study will also address safety and tolerability of chemotherapy response to chemotherapy progression-free survival resectability of liver metastases and serum growth factor levels A total of 84 patients are planned to be entered
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None