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 Transplantationâ€
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- Determine the incidence of grade III and IV mucositis in patients undergoing allogeneic or autologous haematopoietic stem cell transplantation in two groups.
研究概览
简要总结
Patients with various malignancies who are taken up for high dose chemotherapy followed by stem cell transplant (blood and bone marrow) transpalnt have high chances of developing severe oral mucositis(between 95-100%).The mucositis not only causes significant morbidity but also hampers the quality of life so much that pateints at time feel difficult to continue treatment.
No definite treatment exist for prevention and treatment of mucositis in this group of patients.Though one study has suggested that the use of IV palifermin ( a keratinocyte growth factor) will reduce duration and severity of mucositis.Palifermin is very expensive and not available in country.Recently we have shown effectiveness of probiotic Lactobacillus CD2 in reducing incendence and severity of chemo-radiotherapy induce mucositis in Head and Neck squamous cell cancer patients.(Published in European Journal of Cancer 2012;4:875-881) No significant toxicity has been reported with its use.
Now we want to study the efficacy of this drug to reduce the severity of mucositis in patient undergoing myeloablative hematopoetic stem cell transplantation.
Study drug will be provided by the CD Pharma India Pvt Ltd.
The study will be carried out as per ICH GCP and decleration of Helsinki.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 10.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •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  1.8mg/dl.
- •7.Total bilirubin  2mg/dl.
- •8.Liver enzymes within three times of normal limit.
- •9.Expected survival > 6 months.
排除标准
- •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.
结局指标
主要结局
Determine the incidence of grade III and IV mucositis in patients undergoing allogeneic or autologous haematopoietic stem cell transplantation in two groups.
时间窗: daily assessment of mucostits till resolution or day 24 of the treatment.
次要结局
- 1.Determine the incidence of Grade I and II mucositis in patients undergoing allogenic or autologous haematopoietic stem cell transplantation in two groups .(2.Duration of and time period for healing of chemotherapy induced oral mucositis.)