A Pilot study to assess the feasibility of oral cryotherapy for prevention of oral mucositis during administration of cisplatin with radiotherapy in patients with advanced carcinoma of head and neck at TMH.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To assess ease and tolerability of oral cryotherapy.
研究概览
简要总结
Oral mucositis (OM) is a common complication of cancer therapy. Mucositis from damage to the mucosal epithelium after delivery of chemotherapy or radiation designed to treat cancer. OM occurs in approximately 20% to 40% of patients receiving conventional chemotherapy, 80% of patients receiving high-dose chemotherapy, and nearly all patients receiving head and neck radiation therapy (H&N RT). Oral cryotherapy is the application of ice chips or ice-cold water to the mouth. Oral cryotherapy for chemotherapy-induced OM requires that patients suck on ice chips before, during, and after infusions of cytotoxic drugs. It is a low cost, natural treatment without serious side effects. Even in Tata memorial hospital, there are lack of studies reporting the use of oral cryotherapy for patients receiving cancer treatment. So with this pilot trial we would like to evaluate the tolerability and efficacy of oral cryotherapy in patients receiving head and neck cancer treatment where oral mucositis is a common toxicity encountered. If this study proved to be successful then it can be further used for a larger scale studies and in different malignacies with oral toxicity. Null Hypothesis- There will be no ease and tolerabilty for oral cryotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Age > 18 years and ≤ 65years.
- •Stage III or IV squamous cell or undifferentiated carcinoma of the head and neck region originatingin the-oral cavity, oropharynx, hypopharynx, larynx and unknown primary with cervicallymphadenopathy.
- •No evidence of distant metastases.
- •Present at the time of data collection.
- •Patients who can follow instructions.
排除标准
- •Patient who are developmentally or physically unable to perform the intervention.
- •Patients who are not willing to participate.
结局指标
主要结局
To assess ease and tolerability of oral cryotherapy.
时间窗: For cisplatin administration, ease and tolerability of oral cryotherapy will be assessed weekly once or 3 weekly once. | For radiotherapy, ease and tolerability of oral cryotherapy will be assessed daily for week 1, week 2, week 3 and week 4.
次要结局
- 1) To find the incidence of oral mucositis among patients receiving concurrent chemo-radiotherapy after the administration of oral cryotherapy.(2) To evaluate the effectiveness of oral cryotherapy on oral mucositis (the intensity, duration of mucositis, use of concomitant pain medications, pain scores).)