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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr Atul Sharma, All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier:
NCT01480011
First received: November 4, 2011
Last updated: February 19, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Oral Mucositis
Drug: lactobacillus CD2 lozenges
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Pilot Study of Efficacy of Lactobacillus CD2 Lozenges in Preventing High-dose Chemotherapy Induced Oral Mucositis in Patients Undergoing Hematopoietic Stem Cell Transplantation

Resource links provided by NLM:


Further study details as provided by All India Institute of Medical Sciences, New Delhi:

Primary Outcome Measures:
  • incidence of grade III and grade IV mucositis [ Time Frame: Day 24 of stem cell infusion or complete healing of mucositis ] [ Designated as safety issue: Yes ]
    Determine the incidence of grade III and IV mucositis in patients undergoing allogeneic or autologous haematopoietic stem cell transplantation .


Secondary Outcome Measures:
  • grade I and grade II mucositis [ Time Frame: Day 24 of stem cell infusion or complete healing of mucositis ] [ Designated as safety issue: Yes ]
    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


Enrollment: 31
Study Start Date: November 2011
Study Completion Date: December 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: CD#2

  Eligibility

Ages Eligible for Study:   10 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01480011

Locations
India
All India institute of Medical sciences
New Delhi, Delhi, India, 110029
Sponsors and Collaborators
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.
  More Information

Publications:
Responsible Party: Dr Atul Sharma, Additional Professor Medical Oncology, Principal Investigator, All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier: NCT01480011     History of Changes
Other Study ID Numbers: P1101
Study First Received: November 4, 2011
Last Updated: February 19, 2013
Health Authority: India: Drugs Controller General of India

Keywords provided by All India Institute of Medical Sciences, New Delhi:
Lactobacillus CD2 lozenges
high-dose chemotherapy induced
hematopoietic stem cell transplantation

Additional relevant MeSH terms:
Stomatitis
Mucositis
Mouth Diseases
Stomatognathic Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 24, 2014