“A pilot study of efficacy of Lactobacillus CD2 lozenges in preventing high-dose chemotherapy induced oral mucositis in patients undergoing hematopoietic stem cell transplantationâ€
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- 1. Determine the incidence of grade III and IV mucositis in patients undergoing allogeneic or autologous haematopoietic stem cell transplantation
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) transplant) have a very high chance 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 time feel difficult to continue treatment.
No definite treatment exisits for prevention or treatment of oral mucositis in this group of patient .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 a probiotic Lactobacillus CD2 in reducing incidence and severity of chemo-radiotherapy induce mucositis in Head and neck squamous cell cancer patients.(Published one line in European journal of Cancer :http://dx.doi.org/10.1016/j.ejca.2011.06.010) .No significant toxitcity has been reported with its use.
Now we want to study the effecacy of this drug to reduce severity of mucositis in patients undergoing hematopoietic stem cell transplantation.
Study drug will be provided by CD pharma india Pvt Ltd.
The study will be carried out as per ICH GCP and declaration of Helsinki.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
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
1. Determine the incidence of grade III and IV mucositis in patients undergoing allogeneic or autologous haematopoietic stem cell transplantation
时间窗: daily assessment of mucositis till resolution or till 24 days. | whichever is earlier.
次要结局
- 2.Determine the incidence of Grade I and II mucositis in patients undergoing allogeneic or autologous haematopoietic stem cell transplantation (Criteria for assessment is given in Appendix 1).(3.Duration of and time period for healing of chemotherapy induced oral mucositis.)