A Phase III Study of Efficacy of Lactobacillus CD2 Lozenges in Preventing High-Dose Chemotherapy Induced Oral Mucositis in Patients Undergoing Myeloablative Hematopoietic Stem Cell Transplantation

• Status: Withdrawn
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The study will be conducted at departments of Medical Oncology and Hematology, All India Institute of Medical Sciences (AIIMS).

Patients with various malignancies who are taken up for high dose chemotherapy followed by stem cells transplant (blood and marrow transplant) have very high chances of developing severe oral mucositis (generally 60-80% in different studies and our own previous experiences). This not only causes significant morbidity but also hampers quality of life needing use of parenteral nutrition, analgesics, and antibiotics.

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 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)European Journal of Cancer 2012;4:875-881.No significant toxicity has been reported with its use.

A pilot study on similar aspect was completed recently at our center(Clinical trial.gov identifier:NCT 01480011) and in 31 patients who received this only 6 (20%) developed grade III or IV Mucositis. Now, investigators want to study the efficacy of this drug to reduce severity of mucositis in patients undergoing myeloablative hematopoietic stem cell transplantation. The study drug and placebo will be supplied by CD Pharma India Private Limited.

Investigators further give undertaking that study will be carried as per GCP and declaration of Helsinki.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: All India Institute of Medical Sciences, New Delhi

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 as 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 upto 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.