Colorectal CancerPhase 3NCT01410955
Prevention of Irinotecan Induced Diarrhea by Probiotics
A Phase 3 study testing Probiotic formula in people with Colorectal Cancer, run by Monsea Ltd. at 6 sites in Slovakia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Probiotic formula
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 6 sitesSlovakia
- Study dates
- Dec 2011to Jan 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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 )
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Slovakia6 sites
St.James Hospital and Clinic
Bardejov, 085 01
Oncologic Institute of St.Elisabeth OUSA
Bratislava, 81250
National Cancer Institute, Slovakia
Bratislava, 833 10
Zdravspol s r.o. - oncologic ambulance
Komárno, 94501
POKO Poprad Ltd.
Poprad, 058 01
Faculty Hospital Trencin
Trenčín, 91101
About this study
Official title: Prevention of Irinotecan Induced Diarrhea by Probiotics. A Phase III Study
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
- Being tested
- Probiotic formula, Placebo
- Keywords
- probiotics, diarrhoea, prevention, colon cancer, irinotecan
- Medical subject headings
- Colorectal Neoplasms, Diarrhea, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic formulaDietary 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.
PlaceboDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Probiotics | Experimental | Patients receiving probiotics. Receives: Dietary Supplement: Probiotic formula |
| Placebo | Placebo comparator | Patients receiving placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevention of grade 3-4 diarrhea by probiotics in patients treated by irinotecan based chemotherapy
Measured: 2 years
Secondary outcomes (3)
Prevention of any grade of diarrhea
Measured: 2 years
Number of patients with any grade 3 or 4 toxicity or SAE related toxicity.
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).
Measured: 2 years
Number of patients with any grade gastrointestinal symptoms
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2011 (estimated)
- Study startDec 2011
- Primary completionDec 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Monsea Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Harmonium International Inc., Pharma Agency
- Responsible party
- Sponsor
- Investigators
- Michal Mego, MD, PhD, Study chair, National Cancer Institute, SlovakiaLubos Drgona, MD, PhD, Study chair, National Cancer Institute, Slovakia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01410955
- Sponsor's protocol ID
- 900450001
- Status last verified
- Jan 2014
- First submitted
- 26 Apr 2011
- Last updated
- 23 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Irinotecan Induced Diarrhea by Probiotics. A Phase III Study
- ClinicalTrials.gov ID
- NCT01410955
- Acronym / sponsor ID
- 900450001
- Conditions
- Colorectal Cancer
- Keywords
- probiotics, diarrhoea, prevention, colon cancer, irinotecan
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Monsea Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Harmonium International Inc., Pharma Agency
- Study start
- Dec 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 5 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotics | Experimental | Dietary Supplement: Probiotic formulaPatients receiving probiotics. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPatients receiving placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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;
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic formulaProbiotic 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. | Dietary supplement | Probiotics |
| PlaceboPlacebo 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. | Dietary supplement | Placebo |
Primary outcome
Prevention of grade 3-4 diarrhea by probiotics in patients treated by irinotecan based chemotherapy
Time frame: 2 years
3 secondary outcomes
Prevention of any grade of diarrhea
Time frame: 2 years
Number of patients with any grade 3 or 4 toxicity or SAE related toxicity.
Time frame: 2 years
Number of patients with any grade gastrointestinal symptoms
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michal Mego, MD, PhD study chair
National Cancer Institute, Slovakia
Lubos Drgona, MD, PhD study chair
National Cancer Institute, Slovakia
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Probiotic formula in people with Colorectal Cancer, run by Monsea Ltd. at 6 sites in Slovakia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevention of grade 3-4 diarrhea by probiotics in patients treated by irinotecan based chemotherapy (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2014.