A Randomized Controlled Trial for Efficacy of Oral Moisturizing Jelly on Oral Health and Nutrition in Post-radiotherapy Head and Neck Cancer Patients With Xerostomia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 73
- 试验地点
- 2
- 主要终点
- Changes in subjective dry mouth score compared to baseline
研究概览
简要总结
This randomized control trial aims to investigate the efficacy of oral moisturizing jelly in head and neck cancer patients with xerostomia.
详细描述
Oral moisturizing jelly is a novel edible, gel-based artificial saliva. It has been proven effective in reducing dry mouth sign and symptoms in elderly patients with xerostomia. This randomized control trial intends to determine if continuous use of oral moisturizing jelly may be effective in reduction of signs and symptoms of dry mouth, improvement of biochemical properties of saliva, subjective swallow ability, appetite, tolerance to spicy food, energy intake and reduce umami taste recognition threshold.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Xerostomic head and neck cancer patients who finish radiotherapy for at least 1 month.
- •If undergoing chemotherapy, have to finish for at least 2 weeks.
- •Have subjective dry mouth scores at least 3
- •Can perform oral intake without aspiration
- •Can communicate well
排除标准
- •Has recurrence of cancer
- •Has mucositis more than grade 1
- •Has oral infection such as candidiasis
结局指标
主要结局
Changes in subjective dry mouth score compared to baseline
时间窗: Baseline, 1 and 2 months after intervention
Evaluation of subjective dry mouth score by questionaire
次要结局
- Changes in objective dry mouth score compared to baseline(Baseline, 1 and 2 months after intervention)
- Changes in salivary buffering capacity compared to baseline(Baseline, 1 and 2 months after intervention)
- Changes in energy intake compared to baseline(Baseline, 1 and 2 months after intervention)
- Changes in salivary pH compared to baseline(Baseline, 1 and 2 months after intervention)
- Changes in Candidal counts of saliva compared to baseline(Baseline, 1 and 2 months after intervention)
- Changes in subjective swallow ability compared to baseline(Baseline, 1 and 2 months after intervention)
- Changes in appetite compared to baseline(Baseline, 1 and 2 months after intervention)
- Changes in tolerance to spicy food(Baseline, 1 and 2 months after intervention)
- Changes in umami taste recognition threshold compared to baseline(Baseline, 1 and 2 months after intervention)