Oral Mucositis in Patients Undergoing HSCT Clinical Trial
— mucositisOfficial title:
A Randomized Double Blind Placebo Controlled 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
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | December 2016 |
| Est. primary completion date | October 2016 |
| 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 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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| India | Institute Rotary Cancer Hospital,All India Institute of Medical Sciences | New delhi | Delhi |
| Lead Sponsor | Collaborator |
|---|---|
| All India Institute of Medical Sciences, New Delhi |
India,
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
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Safety assessment | 1 Vital Signs (blood pressure, pulse rate and respiratory rate) 2 Laboratory Examinations 5 Adverse Events | D0-D24 | Yes |
| Primary | Incidence of mucositis grade(Common Terminology Criteria of Adverse Events (CTCAE) and World health Organization (WHO) | 1. Determine the incidence of grade III and IV mucositis in patients undergoing allogeneic or autologous haematopoietic stem cell transplantation in two groups | Day 0-Days 24 | Yes |
| Secondary | Incidence,duration and time period of mucositis Common Terminology Criteria of Adverse Events (CTCAE) and World health Organization (WHO) | 1. Determine the incidence of all Grade of mucositis in patients undergoing allogenic or autologous haematopoietic stem cell transplantation in two groups (Criteria for assessment is given in Appendix 1). | Day 0-Days 24 | Yes |
| Secondary | Incidence,duration and time period of mucositis Common Terminology Criteria of Adverse Events (CTCAE) and World health Organization (WHO) | Duration of and time period for healing of chemotherapy induced oral mucositis. | Day0- days 24 | Yes |
| Secondary | Incidence,duration and time period of mucositis Common Terminology Criteria of Adverse Events (CTCAE) and World health Organization (WHO) | Determine incidence and severity of dysphagia and requirement of IV antibiotics in two groups | day 0- days 24 | Yes |