Status:
COMPLETED
A Pilot Study of Efficacy of Lactobacillus CD2 Lozenges in Preventing High-dose Chemotherapy Induced Oral Mucositis in Patients Undergoing Hematopoietic Stem Cell Transplantation
Lead Sponsor:
All India Institute of Medical Sciences
Conditions:
Oral Mucositis
Eligibility:
All Genders
10-70 years
Phase:
PHASE2
Brief Summary
Patients with various malignancies who are taken up for high dose chemotherapy followed by stem cell transplant (blood and marrow transplant) have very high chances of developing severe oral mucositis...
Eligibility Criteria
Inclusion
- Age between 10 and 70 years.
- Karnofsky Performance Score ≥ 70%.
- Confirmed histological diagnosis of cancer/leukaemia for which haematopoietic stem cell transplantation is an approved modality of therapy.
- Patients eligible to receive high-dose chemotherapy as part of conditioning regime.
- Concomitant co morbid condition if present, controlled by medicines.
- Serum creatinine 1.8mg/dl.
- Total bilirubin 2mg/dl.
- Liver enzymes within three times of normal limit.
- Expected survival \> 6 months.
Exclusion
- Pregnant women and lactating mothers.
- Patients with history of AIDS
- Patients who have taken any other investigational product in last 4 weeks.
- Patients having untreated symptomatic dental infection.
- Patients with WHO Grade 3 or 4 oral Mucositis.
- Other serious concurrent illness.
- Inconclusive histological diagnosis.
- Patients on anticancer antibiotics.
- Patients with signs and symptoms of systemic infections.
- Patient's/guardian's refusal to sign informed consent.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT01480011
Start Date
November 1 2011
End Date
December 1 2012
Last Update
February 20 2013
Active Locations (1)
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1
All India institute of Medical sciences
New Delhi, National Capital Territory of Delhi, India, 110029