CTRI/2008/091/000117已完成3 期
A randomized double blind study of efficacy of Lactobacillus brevis CD2 lozenges in preventing radiation and chemotherapy induced oral mucositis in head and neck cancer.
CD Pharma India Pvt. Ltd. C 1/53, Ist floor, SDA, New Delhi-110016, Tel.01141759898, Fax. 011417598940 个研究点目标入组 200 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Inclusion Criteria
- •1.Age between 18 and 70 years.
- •2.Karnofsky Performance Score ≥ 70%.
- •3.Confirmed histological diagnosis of cancer of head and/or neck area.
- •4.Patient not previously treated with chemotherapy and/or radiotherapy except the patients who have received neoadjuvant chemotherapy for current head and neck cancer.
- •5.Patients eligible to receive chemotherapy and/or radiotherapy.
- •6.Concomitant co morbid condition if present, controlled by medicines.
- •7.No distant metastasis.
- •8.Normal bone marrow functions ANC (Absolute neutrophil count) ≥1500/cmm, platelets counts  1, 00,000/cmm).
- •9.Serum creatinine<1.8mg/dl.
- •10.Total bilirubin=< 2mg/dl.
- •11.Liver enzymes within three times of normal limit.
- •12.Expected survival > 6 months.
- •13.Planning to receive a total radiation dose ≥ 5500 cGy, administered in a single daily fraction of 180 - 220 cGy (5 days a week) or twice daily fractions of 110 - 150 cGy.
排除标准
- •1.Patients weighing less than 35 kgs.
- •2.Pregnant women and lactating mothers.
- •3.Patients with history of AIDS, Hepatitis B/ C.
- •4.Patients who have taken any other investigational product in last 4 weeks.
- •5.Patients having untreated symptomatic dental infection.
- •6.Patients with WHO Grade 3 or 4 oral Mucositis.
- •7.Other serious concurrent illness.
- •8.History of Insulin Dependent Diabetes Mellitus.
- •9.Inconclusive histological diagnosis.
- •10.Patients on anticancer antibiotics.
- •11.Patients with signs and symptoms of systemic infections.
- •12.Patient?s refusal to sign informed consent.
研究者
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