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| Name | Class |
|---|---|
| Harmonium International Inc. | INDUSTRY |
| Pharma Agency | UNKNOWN |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotics | Experimental | Patients receiving probiotics. |
|
| Placebo | Placebo Comparator | Patients receiving placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Prevention of grade 3-4 diarrhea by probiotics in patients treated by irinotecan based chemotherapy | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Prevention of any grade of diarrhea | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michal Mego, MD, PhD | National Cancer Institute, Slovakia | Study Chair |
| Lubos Drgona, MD, PhD | National Cancer Institute, Slovakia | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St.James Hospital and Clinic | Bardejov | 085 01 | Slovakia | |||
| Oncologic Institute of St.Elisabeth OUSA |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D003967 | Diarrhea |
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| 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. |
|
| 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. | 2 years |
| Bratislava |
| 81250 |
| Slovakia |
| National Cancer Institute, Slovakia | Bratislava | 833 10 | Slovakia |
| Zdravspol s r.o. - oncologic ambulance | Komárno | 94501 | Slovakia |
| POKO Poprad Ltd. | Poprad | 058 01 | Slovakia |
| Faculty Hospital Trencin | Trenčín | 91101 | Slovakia |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |