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

All India Institute Of Medical Science (AIIMS)

Status and phase: Completed; Phase 2

Conditions: Oral Mucositis

Treatments: Drug: lactobacillus CD2 lozenges

Study type: Interventional

Funder types: Other

Identifiers

NCT01480011

P1101

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: All

Ages: 10 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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31 participants in 1 patient group

lactobacillus lozenges

Experimental group

Description:

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

Treatment:

Drug: lactobacillus CD2 lozenges