Status:
WITHDRAWN
A Phase III Study of Efficacy of Lactobacillus CD2 Lozenges in Preventing High-Dose Chemotherapy Induced Oral Mucositis in Patients Undergoing Myeloablative Hematopoietic Stem Cell Transplantation
Lead Sponsor:
All India Institute of Medical Sciences
Conditions:
Oral Mucositis in Patients Undergoing HSCT
Eligibility:
All Genders
10-70 years
Phase:
PHASE3
Brief Summary
The study will be conducted at departments of Medical Oncology and Hematology, All India Institute of Medical Sciences (AIIMS). Patients with various malignancies who are taken up for high dose chemo...
Detailed Description
Study Design Placebo controlled double blind randomized, multi center clinical trial. Study Population and Number of Subjects Total of 108 patients undergoing myeloablative allogeneic or autologous h...
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 as 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 upto 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 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01797952
Start Date
November 1 2015
End Date
December 1 2016
Last Update
November 9 2016
Active Locations (1)
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1
Institute Rotary Cancer Hospital,All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, India, 110029