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Trial record 19 of 1645 for:    Slovakia

Prevention of Irinotecan Induced Diarrhea by Probiotics

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ClinicalTrials.gov Identifier: NCT02819960
Recruitment Status : Recruiting
First Posted : June 30, 2016
Last Update Posted : January 17, 2019
Sponsor:
Collaborator:
National Cancer Institute, Slovakia
Information provided by (Responsible Party):
S&D Pharma SK s.r.o.

Brief Summary:

Diarrhea is a relatively common complication in patients with cancer. At its inception, several mechanisms participated; malabsorption on the basis of mucositis induced by chemotherapy, dysbiosis induced by broad-spectrum antibiotics and predisposition to infectious diarrhea in immunocompromised patients. Some cytostatics and their metabolites can also induce diarrhea directly due to effect on the intestinal mucosa.

Use of probiotics in prevention and treatment of diarrhea relies on both the theoretical assumptions and the results of several clinical trials. Lactic acid bacteria involved in the treatment of dysbiosis, compete for substrate with pathogenic bacteria, produce bacterio-cins, increase transepithelial resistance. Their enzymatic activity affects activation or deactivation of metabolites which cause diarrhea. Production of short chain fatty acids, which are important for the maintenance of intestinal mucosal cells also contributes to their antidiarrhoeal effect.

This randomized, double-blind, placebo controlled, multicentre trial was designed to evaluate potential of probiotics to prevent grade 3-4 diarrhea in patients treated by irinotecan based chemotherapy during first 6 weeks of irinotecan based chemotherapy


Condition or disease Intervention/treatment Phase
Diarrhea Cancer Drug: PROBIO-FIX INUM® Drug: Placebo Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: Prevention of Irinotecan Induced Diarrhea by Probiotics: A Phase III Study
Study Start Date : March 2016
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

Arm Intervention/treatment
Active Comparator: active probiotic formula

Intervention: Probiotic formula PROBIO-FIX INUM® will be administered at a dose of 3x1 cps per day orally for 6 weeks. No premedication or patient monitoring after administration of probiotic formula is required. Probiotic formula may be taken after meals or snacks to reduce stomach upset. Swallow the capsule or in case of problems with swallowing, capsule can be opened, content mixed with small amount of food. Food must not be hot.

Patients should receive full supportive care during the study, including transfusion of blood and blood products, treatment with antibiotics, anti-emetics, anti-diarrheal agents, analgesics, erythropoetin, or bisphosphonates, when appropriate.

Drug: PROBIO-FIX INUM®
Each capsule contents: 2 lyophilized probiotic strains, total amount of minimum 7x10 9 CFU/cps, ratio LGG®: BB-12® = 50% : 50% (Culture percentages are based on cell concentration and are approximate) Lactobacillus rhamnosus GG® (ATCC 53103) Bifidobacterium animalis subsp. lactis BB-12® (DSM 15954) Additives: maltodextrin, microcrystalline cellulose, silicium dioxide, magnesium stearate
Other Name: PROBIO-FIX INUM

Placebo Comparator: placebo

Intervention: Maltodextrin will be used for placebo group and will be administered at a the same dose as active formula (3x1 cps per day orally for 6 weeks).

Patients should receive full supportive care during the study, including transfusion of blood and blood products, treatment with antibiotics, anti-emetics, anti-diarrheal agents, analgesics, erythropoetin, or bisphosphonates, when appropriate.

Drug: Placebo
Maltodextrin
Other Name: Maltodextrin




Primary Outcome Measures :
  1. Prevention of grade 3-4 diarrhea induced by irinotecan based chemotherapy [ Time Frame: first 6 weeks of irinotecan based chemotherapy ]
    To determine the efficacy (as measured by prevention of grade 3/4 diarrhea) of probiotic formula PROBIO-FIX INUM® given orally to patients with colorectal cancer starting new line of irinotecan based chemotherapy. Response will be defined as prevention of grade 3/4 diarrhea according to definition of NCI CTC version 4.0


Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: 1 year ]
    Progression-free survival period will be evaluated according to standard protocol.

  2. Prevention of any grade of diarrhea [ Time Frame: 6 weeks ]
    To determine the efficacy (as measured by prevention of grade 1/2 diarrhea) of probiotic formula PROBIO-FIX INUM® given orally to patients with colorectal cancer during first 6 weeks of irinotecan based chemotherapy. Response will be defined as prevention of grade 1/2 diarrhea according to definition of NCI CTC version 4.0

  3. Prevention of other gastrointestinal symptoms [ Time Frame: 6 weeks ]
    To determine the efficacy (as measured by prevention of enterocolitis) of probiotic formula PROBIO-FIX INUM® given orally to patients with colorectal cancer starting new line of irinotecan based chemotherapy. Response will be defined as prevention of enterocolitis during first 6 weeks of irinotecan based chemotherapy according to definition of NCI CTC version 4.0.

  4. Incidence of treatment-emergent adverse events [Safety and Toxicity] [ Time Frame: 6 weeks ]
    Safety and toxicity will be evaluated according to NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE) (see Appendix D; http://www.fda.gov/cder/cancer/toxicityframe.htm).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • signed written informed consent
  • age > 18 years
  • histologically proven colorectal cancer patients starting 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
  • ileostoma
  • 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 )

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02819960


Contacts
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Contact: Michal Mego, MD 00421904442530 misomego@gmail.com
Contact: Lubos Drgona, MD 00421259 378 512 lubos.drgona@nou.sk

Locations
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Slovakia
National Cancer Institute Recruiting
Bratislava, Slovakia, 833 10
Contact: Michal Mego, MD    00421904442530    misomego@gmail.com   
Contact: Lubos Drgona, MD    00421259 378 512    lubos.drgona@nou.sk   
Sponsors and Collaborators
S&D Pharma SK s.r.o.
National Cancer Institute, Slovakia
Investigators
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Principal Investigator: Michal Mego, MD National Cancer Institute, Bratislava
Principal Investigator: Lubos Drgona, MD National Cancer Institute, Bratislava

Publications of Results:
Other Publications:
Salek T, Mardiak J, Obertova J, Sycova-Mila Z, Koza I. New weekly schedule of irinotecan as second line treatment in advanced colorectal cancer. Proc Am Soc Clin Oncol 21: 2378, 2002.

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Responsible Party: S&D Pharma SK s.r.o.
ClinicalTrials.gov Identifier: NCT02819960     History of Changes
Other Study ID Numbers: 2
First Posted: June 30, 2016    Key Record Dates
Last Update Posted: January 17, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by S&D Pharma SK s.r.o.:
probiotics
irinotecan
diarrhea
Lactobacillus rhamnosus
Bifidobacterium animalis
prevention
chemotherapy
Additional relevant MeSH terms:
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Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
Irinotecan
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents