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NCT Number: NCT01410955

Prevention of Irinotecan Induced Diarrhea by Probiotics

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Diarrhea Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Rectal Diseases Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

St.James Hospital and Clinic, Bardejov, Slovakia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 )

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: 2 years

Secondary outcomes

  1. Prevention of any grade of diarrhea

    Time frame: 2 years

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

    Time frame: 2 years

    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).

  3. Number of patients with any grade gastrointestinal symptoms

    Time frame: 2 years

    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.

Sponsors and collaborators

Lead sponsor

Monsea Ltd.

Industry

Collaborators

  • Harmonium International Inc.
  • Pharma Agency

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Aug 5, 2011
Registry last updated
Jan 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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