Know Cancer

or
forgot password

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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Colorectal Cancer

Thank you

Trial Information

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


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 )

Type of Study:

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

Outcome Measure:

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

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Michal Mego, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

National Cancer Institute, Slovakia

Authority:

Slovak Republic: Ethics Committee

Study ID:

900450001

NCT ID:

NCT01410955

Start Date:

December 2011

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • probiotics
  • diarrhoea
  • prevention
  • colon cancer
  • irinotecan
  • Colorectal Neoplasms
  • Diarrhea

Name

Location