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

Oral Mucositis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01480011
• Other study ID #: P1101
• Status: Completed
• Phase: Phase 2
• First received: November 4, 2011
• Last updated: February 19, 2013
• Start date: November 2011
• Est. completion date: December 2012

Study information

• Verified date: February 2013
• Source: All India Institute of Medical Sciences, New Delhi
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Drugs Controller General of India
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: December 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 70 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Mucositis
• Oral Mucositis
• Stomatitis

Intervention

Drug:
• lactobacillus CD2 lozenges
The study drug contains not less than 2x109 (2 billion) viable cells of Lactobacillus CD2 as active ingredient

Locations

Country	Name	City	State
India	All India institute of Medical sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
All India Institute of Medical Sciences, New Delhi

Country where clinical trial is conducted

India, 

References & Publications (1)

Sharma A, Rath GK, Chaudhary SP, Thakar A, Mohanti BK, Bahadur S. Lactobacillus brevis CD2 lozenges reduce radiation- and chemotherapy-induced mucositis in patients with head and neck cancer: a randomized double-blind placebo-controlled study. Eur J Cance — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes