“Development and evluation of an Oral care protocol on chemotherapy and radiation therapy induced oral complications in cancer patients: single blind, randomized clinical trialâ€
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Occurrence of oral complications by using oral health assessment sheet
研究概览
简要总结
This study is a randomized, single blind, parallel group; trial for evaluating the effectiveness of oral care protocol for chemotherapy and radiation therapy induced oral complications among cancer patients. Experimental arm in this study will be receiving oral care protocol intervention and control arm participants will be receiving standard of care of oral care. The primary outcome measures will be occurrence of oral complications developed during the cancer treatment and from there after upto 1 year. The secondary outcomes will be duration of hospitalization and cost analysis related to occurrence of oral complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
入选标准
- •Ages Eligible for Study: 18 Years and older Genders Eligible for Study: Both Chemotherapy Patient Group Patient inclusion criteria Patients newly diagnosed to have cancer and receiving selected mucotoxic chemotherapy drugs.
- •Patients admitted in Medical Oncology wards and special wards.
- •Patients who are willing to participate in the study.
- •Radiation Therapy Patient Group Patient inclusion criteria Patients admitted in Radiation Oncology and special wards Patients planned for the radiation to the head and neck area.
- •Patients who are in any stage of cancer receiving chemoradiation, only radiation or post-operative radiation.
- •Atleast 75% of both parotids are within the radiation field.
- •Patients who are willing to take part in the study.
排除标准
- •Patient exclusion criteria Patients with cancers other than those affecting the oropharyngeal region.
结局指标
主要结局
Occurrence of oral complications by using oral health assessment sheet
时间窗: Patient assessment once a week during admission for Radiation/chemoratiation. Patient assessment once in every cycle of chemotherapy. Followup assessment once in two months after discharge upto 1 year following Radiation therapy/Chemoradiation/chemotherapy.
次要结局
- Functional activities of the mouth (swallowing, taste, pain, self oral care) by using a checklist(1 year)
- Duration of Hospitalization
- Cost analysis:(Loss of productive days for patient/ relative, extra consultation costs due to complications, extra costs like food, transportation, length of stay.)