Mucositis is one of the most common problem in patients who are undergoing stem cell transplant receiving high dose chemotherapy in patients undergoing hematopoietic stem cell transplantation.

Phase 2

Completed

• Conditions: Health Condition 1: null- Prevention of mucositis in the group of patients undergoing hematopoetic stem cell transplant

• Registration Number: CTRI/2011/11/002140
• Lead Sponsor: CD Pharma India pvt ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

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.

Exclusion Criteria

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
1. Determine the incidence of grade III and IV mucositis in patients undergoing allogeneic or autologous haematopoietic stem cell transplantationTimepoint: daily assessment of mucositis till resolution or till 24 days. <br/ ><br>whichever is earlier.

Secondary Outcome Measures

Name	Time	Method
2.Determine the incidence of Grade I and II mucositis in patients undergoing allogeneic or autologous haematopoietic stem cell transplantation (Criteria for assessment is given in Appendix 1). <br/ ><br>3.Duration of and time period for healing of chemotherapy induced oral mucositis. <br/ ><br>4.Determine incidence and severity of dysphagia <br/ ><br>Timepoint: daily assessment of mucostits till resolution or day 24 of the treatment.