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A Pilot Study of Efficacy of Lactobacillus CD2 Lozenges in Preventing High-dose Chemotherapy Induced Oral Mucositis in Patients Undergoing Hematopoietic Stem Cell Transplantation


Phase 2
10 Years
70 Years
Not Enrolling
Both
Oral Mucositis

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Trial Information

A Pilot Study of Efficacy of Lactobacillus CD2 Lozenges in Preventing High-dose Chemotherapy Induced Oral Mucositis in Patients Undergoing Hematopoietic Stem Cell Transplantation


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 an 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 1.8mg/dl.

7. Total bilirubin 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. Patient's/guardian's refusal to sign informed consent.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

incidence of grade III and grade IV mucositis

Outcome Description:

Determine the incidence of grade III and IV mucositis in patients undergoing allogeneic or autologous haematopoietic stem cell transplantation .

Outcome Time Frame:

Day 24 of stem cell infusion or complete healing of mucositis

Safety Issue:

Yes

Principal Investigator

Atul Sharma, MD,DM

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dr BRA Institute Rotary Cancer Hospital ,All India Institute of Medical Sciences,New Delhi ,India.

Authority:

India: Drugs Controller General of India

Study ID:

P1101

NCT ID:

NCT01480011

Start Date:

November 2011

Completion Date:

December 2012

Related Keywords:

  • Oral Mucositis
  • Lactobacillus CD2 lozenges
  • high-dose chemotherapy induced
  • hematopoietic stem cell transplantation
  • Stomatitis
  • Mucositis

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