A clinical trial to study the efficacy of probiotic VSL#3 on chemotherapy-induced diarrhoea in cancer patients recieving Fluropyrimidines and/or Irinotecan.
- Conditions
- Health Condition 1: null- Prevention of Chemotherapy-induced diarrhoea in cancer patients receiving Fluropyrimidines and/or Irinotecan
- Registration Number
- CTRI/2009/091/001042
- Lead Sponsor
- CD Pharma India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 242
1.Patients, 18 years or older
2.Patients with histologically confirmed diagnosis of cancer
3.Patients advised for fluouropyrimodines and or irinotecan based chemotherapy
4.Patients with recurrent disease must have completed last chemotherapy 4 weeks prior to enrollment in study
5.Patients with ECOG less than or equal to 2
Patients who meet any one of the following exclusion criteria will not be enrolled in this study;
1.Patients unable to take oral medication
2.Patients with inflammatory bowel disease, colostomy or ileostomy.
3.Patients with ECOG >2
4.Patients with ANC <1500 microlitre
5.Patients on treatment with antibiotics within a a week before initiation of probiotic supplement (with the exception of standard food yogurt products).
6.Patients with Pregnancy (positive serum pregnancy test) or lactation
7.Patients undergoing concurrent radiotherapy
8.Patients with known intolerance or allergy to VSL#3
9.Any severe, unresolved or unstable acute illness (any pre-existing chronic illness likely to compromise efficacy and safety and will prevent from participation in the study like severe heart disease, hepatic disease, pulmonary disease, insulin dependent diabetes, hyperactive thyroid gland, HIV positive, etc.)
10.Patients with history of major psychiatric disorder or substance abuse within the previous 2 years, including psychiatric illness requiring medication
11.Patients participating in any other clinical study during the past four weeks.
12.Patients on systemic corticosteroids
13. Patient's refusal to sign informed consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence and duration of grade 3 & 4 diarrhea caused by Fluropyrimidines and/or Irinotecan in VSL#3 group compared to placebo <br/ ><br>Timepoint: At all chemotherapy cycles that is cycle 1, 2 and 3 of chemotherapy and at the follow-up visit i.e two weeks after 3rd cycle of chemotherapy
- Secondary Outcome Measures
Name Time Method 1.Reduction in use of rescue medications (loperamide, antibiotics for diarrhea) <br/ ><br>2.Weight loss <br/ ><br>3.Frequency of use of TPN (Total Parenteral Nutrition) <br/ ><br>4.Frequency of use of I.V. fluids <br/ ><br>5.Incidence and duration of all grades diarrhea <br/ ><br>6.Assessment of Health-related quality of life <br/ ><br>7.Incidence of oral mucositis <br/ ><br>8.Incidence of grade III or IV neutropenia <br/ ><br>9.Stool consistency (Bristol stool chart) <br/ ><br>10.Chemotherapy dose modification <br/ ><br>11.Chemotherapy treatment delays <br/ ><br>Timepoint: At all chemotherapy cycles that is cycle 1, 2 and 3 of chemotherapy and at the follow-up visit that is (two weeks after 3rd cycle of chemotherapy)