Prevention of Irinotecan Induced Diarrhea by Probiotics

Colorectal Cancer Clinical Trial

Official title:

Prevention of Irinotecan Induced Diarrhea by Probiotics. A Phase III Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01410955
• Other study ID #: 900450001
• Status: Completed
• Phase: Phase 3
• First received: April 26, 2011
• Last updated: January 22, 2014
• Start date: December 2011
• Est. completion date: January 2014

Study information

• Verified date: January 2014
• Source: Monsea Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Slovak Republic: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: January 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 )

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Diarrhea

Intervention

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
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.

Locations

Country	Name	City	State
Slovakia	St.James Hospital and Clinic	Bardejov
Slovakia	National Cancer Institute, Slovakia	Bratislava
Slovakia	Oncologic Institute of St.Elisabeth OUSA	Bratislava
Slovakia	Zdravspol s r.o. - oncologic ambulance	Komarno
Slovakia	POKO Poprad Ltd.	Poprad
Slovakia	Faculty Hospital Trencin	Trencin

Sponsors (3)

Lead Sponsor	Collaborator
Monsea Ltd.	Harmonium International Inc., Pharma Agency

Country where clinical trial is conducted

Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevention of grade 3-4 diarrhea by probiotics in patients treated by irinotecan based chemotherapy		2 years	No
Secondary	Prevention of any grade of diarrhea		2 years	No
Secondary	Number of patients with any grade 3 or 4 toxicity or SAE related toxicity.	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).	2 years	Yes
Secondary	Number of patients with any grade gastrointestinal symptoms	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.	2 years	No