Prevention of Irinotecan Induced Diarrhea by Probiotics
This study is currently recruiting participants.
Verified September 2012 by Monsea Ltd.
Sponsor:
Monsea Ltd.
Collaborators:
Harmonium International Inc.
Pharma Agency
Information provided by (Responsible Party):
Monsea Ltd.
ClinicalTrials.gov Identifier:
NCT01410955
First received: April 26, 2011
Last updated: September 20, 2012
Last verified: September 2012
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Purpose
Irinotecan is one of key drug used in the treatment of colorectal cancer. The incidence of irinotecan induced diarrhea varies between 60-90%, with severe diarrhea in 20-40%. The main cause of diarrhea is one of irinotecan metabolites, SN-38 which is in the liver glucuronidated and subsequently expelled into the intestine. Due to the bacterial enzyme beta-D-glucuronidase in intestinal lumen it is deconjugated. This form causes direct damage of intestinal mucosa associated with malabsorption and the development of diarrhea. It is known that probiotic bacteria, reduce activity of intestinal beta-D-glucuronidase and therefore these bacteria could be applied in the prevention of diarrhea in patients treated by this food supplement. Given their low toxicity, good tolerability, probiotics may be an important part of supportive therapy. This is a first study aimed to determine the effectiveness of the probiotics in the prophylaxis of irinotecan induced diarrhea due to reduction intestinal beta-D-glucuronidase activity.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer |
Dietary Supplement: Probiotic formula Dietary Supplement: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Prevention of Irinotecan Induced Diarrhea by Probiotics. A Phase III Study |
Resource links provided by NLM:
Further study details as provided by Monsea Ltd.:
Primary Outcome Measures:
- Prevention of grade 3-4 diarrhea by probiotics in patients treated by irinotecan based chemotherapy [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Prevention of any grade of diarrhea [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Number of patients with any grade 3 or 4 toxicity or SAE related toxicity. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]Number of patients with any grade 3 or 4 toxicity or SAE related toxicity according to NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
- Number of patients with any grade gastrointestinal symptoms [ Time Frame: 2 years ] [ Designated as safety issue: No ]Number of patients with any grade gastrointestinal symptoms (enteritis, colitis, constipation, abdominal distension, bloating, flatulence, gastritis, dyspepsia,nausea, vomiting) according to NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE.
| Estimated Enrollment: | 220 |
| Study Start Date: | December 2011 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Probiotics
Patients receiving probiotics.
|
Dietary Supplement: Probiotic formula
Probiotic formula Colon DophilusTM , will be administered at a dose of 3x1 cps per day orally for 12 weeks. In the first cycle the starting dose is 3x1 cps per day. In other cycles the starting dose is 3x1 cps per day, or the dose according to dose adjustments from the previous treatment cycle.
|
|
Placebo Comparator: Placebo
Patients receiving placebo
|
Dietary Supplement: Placebo
Placebo capsules will be administered at a dose of 3x1 cps per day orally for 12 weeks. In the first cycle the starting dose is 3x1 cps per day. In other cycles the starting dose is 3x1 cps per day, or the dose according to dose adjustments from the previous treatment cycle.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- signed written informed consent
- histologically proven colorectal cancer patients started new line of chemotherapy based on irinotecan
- ECOG PS 0 - 1 at study entry
- life expectancy more than 3 months
- absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule;
Exclusion Criteria:
- impossibility to take oral medication
- active infection treated by antibiotic therapy
- ileostomy
- hypersensitivity to study drug
- any concurrent malignancy other than non-melanoma skin cancer, no other cancer in past 5 years.
- serious concomitant systemic disorders or diseases incompatible with the study (at the discretion of investigator )
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01410955
Contacts
| Contact: Dagmar Mikusova, Dr | +421-911216717 | mikusova@monsea.sk |
Locations
| Slovakia | |
| St.James Hospital and Clinic | Recruiting |
| Bardejov, Slovakia, 085 01 | |
| Contact: Jozef Chovanec, MD jozefchovanec@nsp-bardejov.sk | |
| Sub-Investigator: Jozef Chovanec, MD | |
| National Cancer Institute, Slovakia | Recruiting |
| Bratislava, Slovakia, 833 10 | |
| Contact: Tomas Salek, MD | |
| Principal Investigator: Michal Mego, MD, PhD | |
| Principal Investigator: Lubos Drgona, MD, PhD | |
| Sub-Investigator: Iveta Andrezalova, MD | |
| Sub-Investigator: Michaela Kubickova, MD | |
| Sub-Investigator: Eva Oravcova, MD | |
| Sub-Investigator: Radoslav Greksak, MD | |
| Sub-Investigator: Patrik Palacka, MD | |
| Oncologic Institute of St.Elisabeth OUSA | Recruiting |
| Bratislava, Slovakia, 81250 | |
| Contact: Milada Mikulová, MDA mmikulov@ousa.sk | |
| Sub-Investigator: Vanda Usakova, MD | |
| Principal Investigator: Milada Mikulová, MD | |
| Sub-Investigator: Viera Miskovska, MD | |
| Zdravspol s r.o. - oncologic ambulance | Recruiting |
| Komarno, Slovakia, 94501 | |
| Contact: Peter Konkolovský, MD 00421 903 686 679 peter.konkolovsky@gmail.com | |
| Principal Investigator: Peter Konkolovsky, MD | |
| Sub-Investigator: Eva Konkolovská, MD | |
| National cancer Institute | Recruiting |
| Košice, Slovakia, 04191 | |
| Contact: Maria Wagnerova, MD wagnerova@vou.sk | |
| Sub-Investigator: Maria Wagnerova, MD | |
| POKO Poprad Ltd. | Recruiting |
| Poprad, Slovakia, 058 01 | |
| Contact: Maria Reckova, MD maryrecka@gmail.com | |
| Sub-Investigator: Maria Reckova, MD | |
| Sub-Investigator: Marian Kakalejcik, MD | |
| Sub-Investigator: Juraj Beniak, MD | |
| Sub-Investigator: Lenka Medvecova, MD | |
| Faculty Hospital Trencin | Recruiting |
| Trencin, Slovakia, 91101 | |
| Contact: Branislav Bystrický, MD branislav.bystricky@fntn.sk | |
| Principal Investigator: Branislav Bystrický, MD | |
Sponsors and Collaborators
Monsea Ltd.
Harmonium International Inc.
Pharma Agency
Investigators
| Study Chair: | Michal Mego, MD, PhD | National Cancer Institute, Slovakia |
| Study Chair: | Lubos Drgona, MD, PhD | National Cancer Institute, Slovakia |
More Information
No publications provided
| Responsible Party: | Monsea Ltd. |
| ClinicalTrials.gov Identifier: | NCT01410955 History of Changes |
| Other Study ID Numbers: | 900450001 |
| Study First Received: | April 26, 2011 |
| Last Updated: | September 20, 2012 |
| Health Authority: | Slovak Republic: Ethics Committee |
Keywords provided by Monsea Ltd.:
|
probiotics diarrhoea prevention colon cancer irinotecan |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Diarrhea Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Signs and Symptoms, Digestive |
Signs and Symptoms Irinotecan Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013