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Sponsored by: |
Helsinki University |
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Information provided by: | Helsinki University |
ClinicalTrials.gov Identifier: | NCT00197873 |
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 moderate/severe diarrhoea. The study will also address safety and tolerability of chemotherapy, response to chemotherapy, and serum growth factor levels.
Condition | Intervention | Phase |
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Colorectal Cancer |
Behavioral: Lactobacillus Rhamnosus supplementation Other: Placebo administration. |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study |
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 |
Estimated Enrollment: | 84 |
Study Start Date: | September 2005 |
Estimated Study Completion Date: | October 2010 |
Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Active Comparator
Lactophilus supplementation
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Behavioral: Lactobacillus Rhamnosus supplementation
Lactophilus supplementation is administered during chemotherapy.
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B: Placebo Comparator
Placebo is administered during chemotherapy.
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Other: Placebo administration.
Placebo is administered during chemotherapy.
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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 moderate/severe 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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Heikki Joensuu, M.D. | +358-9-471 73208 | heikki.joensuu@hus.fi |
Contact: Pia Österlund, M.D. | +358-9-4711 | pia.osterlund@hus.fi |
Finland | |
Department of Oncology | Recruiting |
Helsinki, Finland, FIN-00029 | |
Contact: Heikki Joensuu, M.D. +358-9-471 73208 heikki.joensuu@hus.fi | |
Contact: Pia Österlund, M.D. +358-9-4711 pia.osterlund@hus.fi | |
Principal Investigator: Heikki Joensuu, M.D. |
Study Director: | Heikki Joensuu, M.D. | Department of Oncology, Helsinki University Central Hospital |
Responsible Party: | Department of Oncology, Helsinki University Central Hospital ( Heikki Joensuu, MD ) |
Study ID Numbers: | ML18581, The "lactAXE" trial |
Study First Received: | September 12, 2005 |
Last Updated: | May 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00197873 History of Changes |
Health Authority: | Finland: National Agency for Medicines |
colorectal cancer probiotics chemotherapy |
prevention adverse effects diarrhoea |
Digestive System Diseases Digestive System Neoplasms Diarrhea Gastrointestinal Diseases Colonic Diseases |
Gastrointestinal Neoplasms Intestinal Diseases Rectal Diseases Intestinal Neoplasms Colorectal Neoplasms |
Neoplasms Digestive System Diseases Neoplasms by Site Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases |
Gastrointestinal Neoplasms Intestinal Diseases Rectal Diseases Intestinal Neoplasms Colorectal Neoplasms |