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

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.

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Key information

Conditions

Oral Mucositis Mouth Diseases Stomatitis Stomatognathic Diseases

Age range

10 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

All India institute of Medical sciences

New Delhi, National Capital Territory of Delhi, 110029, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

lactobacillus CD2 lozenges

Drug

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

Other names: CD#2

Primary outcomes

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 .

Secondary outcomes

grade I and grade II mucositis

Time frame: Day 24 of stem cell infusion or complete healing of 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

Sponsors and collaborators

Lead sponsor

All India Institute of Medical Sciences

Other

Registry information

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: Nov 28, 2011
Registry last updated: Feb 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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