Prevention of Irinotecan Induced Diarrhea by Probiotics

NCT01410955 | Completed Phase 3

• 1 other identifier: 900450001
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Colorectal Cancer

Keywords

probiotics; diarrhoea; prevention; colon cancer; irinotecan

Outcome Measures

Primary Outcomes (1)

• Prevention of grade 3-4 diarrhea by probiotics in patients treated by irinotecan based chemotherapy

  2 years

Secondary Outcomes (3)

• Prevention of any grade of diarrhea

  2 years

• Number of patients with any grade 3 or 4 toxicity or SAE related toxicity.

  2 years

• Number of patients with any grade gastrointestinal symptoms

  2 years

Study Arms (2)

Probiotics

EXPERIMENTAL

Patients receiving probiotics.

Dietary Supplement: Probiotic formula

Placebo

PLACEBO COMPARATOR

Patients receiving placebo

Dietary Supplement: Placebo

Interventions

Probiotic formula DIETARY_SUPPLEMENT

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.

Probiotics

Placebo DIETARY_SUPPLEMENT

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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 )

Sponsors & Collaborators

• Monsea Ltd.: lead
• Harmonium International Inc.: collaborator
• Pharma Agency: collaborator

Study Sites (6)

St.James Hospital and Clinic

Bardejov, 085 01, Slovakia

Location

Oncologic Institute of St.Elisabeth OUSA

Bratislava, 81250, Slovakia

Location

National Cancer Institute, Slovakia

Bratislava, 833 10, Slovakia

Location

Zdravspol s r.o. - oncologic ambulance

Komárno, 94501, Slovakia

Location

POKO Poprad Ltd.

Poprad, 058 01, Slovakia

Location

Faculty Hospital Trencin

Trenčín, 91101, Slovakia

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Diarrhea; Colonic Neoplasms

Condition Hierarchy (Ancestors)

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; Pathological Conditions, Signs and Symptoms

Study Officials

• Michal Mego, MD, PhD

  National Cancer Institute, Slovakia

  STUDY CHAIR

• Lubos Drgona, MD, PhD

  National Cancer Institute, Slovakia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2011
• First Posted: August 5, 2011
• Study Start: December 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: January 1, 2014
• Last Updated: January 23, 2014

Record last verified: 2014-01

Locations

SL (6)