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

February 19, 2013 updated by: Dr Atul Sharma, All India Institute of Medical Sciences, New Delhi

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Delhi
      • New Delhi, Delhi, India, 110029
        • All India Institute of Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: lactobacillus lozenges
The study drug contains not less than 2x109 (2 billion) viable cells of Lactobacillus CD2 as active ingredient
Drug: lactobacillus CD2 lozenges
The study drug contains not less than 2x109 (2 billion) viable cells of Lactobacillus CD2 as active ingredient
Other Names:
  • CD#2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of grade III and grade IV mucositis
Time Frame: Day 24 of stem cell infusion or complete healing of mucositis
Determine the incidence of grade III and IV mucositis in patients undergoing allogeneic or autologous haematopoietic stem cell transplantation .
Day 24 of stem cell infusion or complete healing of mucositis

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
grade I and grade II mucositis
Time Frame: Day 24 of stem cell infusion or complete healing of mucositis
  1. Determine the incidence of Grade I and II mucositis in patients undergoing allogenic or autologous haematopoietic stem cell transplantation.
  2. Duration of and time period for healing of chemotherapy induced oral mucositis.
  3. Determine incidence and severity of dysphagia
Day 24 of stem cell infusion or complete healing of mucositis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

All India Institute of Medical Sciences, New Delhi

Investigators

  • Principal Investigator: Atul Sharma, MD,DM, Dr BRA Institute Rotary Cancer Hospital ,All India Institute of Medical Sciences,New Delhi ,India.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

November 4, 2011

First Submitted That Met QC Criteria

November 25, 2011

First Posted (Estimate)

November 28, 2011

Study Record Updates

Last Update Posted (Estimate)

February 20, 2013

Last Update Submitted That Met QC Criteria

February 19, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P1101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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