Mucositis is one of the most common problem in patients who are undergoing stem cell transplant receiving high dose chemotherapy.Lactobacillus cd2(probiotics is being investigated)in this study in the prevention of mucositis(oral ulcers).
- Conditions
- Health Condition 1: null- Prevention of mucositis in the group of patients undergoing myeloablative hematopoetic stem cell transplant
- Registration Number
- CTRI/2013/02/003393
- Lead Sponsor
- CD Pharma India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 108
1.Age between 10 and 70 years.
2.Karnofsky Performance Score >= 70%.
3.Confirmed histological diagnosis of cancer/leukaemia for which haematopoietic stem cell transplantation is as approved modality of therapy.
4.Patients eligible to receive high-dose chemotherapy as part of conditioning regime.
5.Concomitant co morbid condition if present, controlled by medicines.
6.Serum creatinine ï?¼ 1.8mg/dl.
7.Total bilirubin ï?¼ 2mg/dl.
8.Liver enzymes within three times of normal limit.
9.Expected survival > 6 months
1.Pregnant women and lactating mothers.
2.Patients with history of AIDS
3.Patients who have taken any other investigational product in last 4 weeks.
4.Patients having untreated symptomatic dental infection.
5.Patients with WHO Grade 3 or 4 oral Mucositis.
6.Other serious concurrent illness.
7.Inconclusive histological diagnosis.
8.Patients on anticancer antibiotics.
9.Patients with signs and symptoms of systemic infections.
10.Patientâ??s/guardianâ??s refusal to sign informed consent.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Determine the incidence of grade III and IV mucositis in patients undergoing allogeneic or autologous haematopoietic stem cell transplantation in two groups.Timepoint: daily assessment of mucostits till resolution or day 24 of the treatment.
- Secondary Outcome Measures
Name Time Method 1.Determine the incidence of Grade I and II mucositis in patients undergoing allogenic or autologous haematopoietic stem cell transplantation in two groups . <br/ ><br>2.Duration of and time period for healing of chemotherapy induced oral mucositis. <br/ ><br>3.Determine incidence and severity of dysphagia and requirement of IV antibiotics in two groups <br/ ><br>Timepoint: daily assessment of mucostits till resolution or day 24 of the treatment.