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

Study Overview
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Brief Summary
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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.

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

Conditions
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Oral Mucositis

Intervention / Treatment
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* Drug: lactobacillus CD2 lozenges


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: lactobacillus lozenges<br>The study drug contains not less than 2x109 (2 billion) viable cells of Lactobacillus CD2 as active ingredient | Drug: lactobacillus CD2 lozenges<br>* The study drug contains not less than 2x109 (2 billion) viable cells of Lactobacillus CD2 as active ingredient<br>* Other names: CD#2;|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lactobacillus CD2 lozenges, high-dose chemotherapy induced, hematopoietic stem cell transplantation