Clinical trial NCT01410955: Prevention of Irinotecan Induced Diarrhea by Probiotics
Official title: Prevention of Irinotecan Induced Diarrhea by Probiotics. A Phase III Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colorectal Cancer
Keywords: probiotics
diarrhoea
prevention
colon cancer
irinotecan
Lead sponsor: Monsea Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Harmonium International Inc.
name: Pharma Agency
First posted: 2011-08-05
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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 )

Primary outcomes:
measure: Prevention of grade 3-4 diarrhea by probiotics in patients treated by irinotecan based chemotherapy
timeFrame: 2 years
Secondary outcomes:
measure: Prevention of any grade of diarrhea
timeFrame: 2 years
measure: Number of patients with any grade 3 or 4 toxicity or SAE related toxicity.
timeFrame: 2 years
measure: Number of patients with any grade gastrointestinal symptoms
timeFrame: 2 years
Other outcomes:
Locations:
city: Bardejov
country: Slovakia
facility: St.James Hospital and Clinic
city: Bratislava
country: Slovakia
facility: Oncologic Institute of St.Elisabeth OUSA
city: Bratislava
country: Slovakia
facility: National Cancer Institute, Slovakia
city: Komarno
country: Slovakia
facility: Zdravspol s r.o. - oncologic ambulance
city: Poprad
country: Slovakia
facility: POKO Poprad Ltd.
city: Trencin
country: Slovakia
facility: Faculty Hospital Trencin
Study officials:
affiliation: National Cancer Institute, Slovakia
name: Michal Mego, MD, PhD
role: STUDY_CHAIR
affiliation: National Cancer Institute, Slovakia
name: Lubos Drgona, MD, PhD
role: STUDY_CHAIR
References: