NCT01480011

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: All India Institute of Medical Sciences · Academic / Other
• Sex: All
• Age: 10 Years – 70 Years
• Healthy volunteers: Not accepted

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 (between 95-100%). This mucositis not only causes significant morbidity but also hampers quality of life so much so that patients at times feel difficult to continue treatment. No definite treatment exists for prevention or treatment of oral mucositis in this group of patients. Though one study has suggested that use of IV palifermin (a keratinocyte growth factor) will reduce duration and severity. Palifermin is very expensive and not available in country. Recently the investigators have shown effectiveness of a probiotic Lactobacillus CD 2 in reducing incidence and severity of chemo-radiotherapy induced mucositis in head and neck squamous cell cancer patients. (Published online in European Journal of Cancer: http://dx.doi.org/10.1016/j.ejca.2011.06.010). No significant toxicity has been reported with its use. Now, the investigators want to study the efficacy of this drug to reduce severity of mucositis in patients undergoing hematopoietic stem cell transplantation. The drug will be supplied by CD Pharma India Private Limited. The investigators further give undertaking that study will be carried as per good clinical practices (GCP) and declaration of Helsinki.

Conditions

• Oral Mucositis

Interventions

Type	Name	Description
DRUG	lactobacillus CD2 lozenges	The study drug contains not less than 2x109 (2 billion) viable cells of Lactobacillus CD2 as active ingredient

Timeline

• Start date: 2011-11-01
• Primary completion: 2012-09-01
• Completion: 2012-12-01
• First posted: 2011-11-28
• Last updated: 2013-02-20

Locations

1 site across 1 country: India