The Use of Chewing Gum for Xerostomia and Hyposalivation After Radiotherapy for Oral and Oropharyngeal Tumors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 109
- 试验地点
- 2
- 主要终点
- Salivary flow (intervention arm)
研究概览
简要总结
This study evaluates the possible benefits of a tasteless and sugar free chewing gum as a salivary stimulant for head and neck cancer patients treated with curative intended radiotherapy.
详细描述
Radiation-induced xerostomia and hyposalivation are frequent side effects after completed treatment for oral and oropharyngeal cancers. This may induce eating and swallowing difficulties, compromised oral hygiene, pain in the mouth, or speech deficiencies. As a consequence, quality of life is often impaired for this group of patients even after completing treatment.
This study hypothesize that chewing gum can stimulate salivary flow from the residual functional salivary glands and thereby improving the patient's oral well-being.
Primary endpoint:
- To assess whether the difference between the unstimulated and stimulated salivary flow after a one-month period of using chewing gum will result in improved oral well-being.
Secondary endpoint:
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over 18 years of age
- •Diagnosed with oral or oropharyngeal carcinoma
- •Received curative intended radiation therapy (primary or postoperative), 60-66Gy including concurrent chemotherapy
- •Within 6 to 60 months after radiation therapy
- •Complains of xerostomia level 1 (according to Danish Head and Neck Cancer group)
- •Written informed consent
排除标准
- •Poor teeth condition or full set of dentures
- •Recurrence of cancer or palliative treatment
研究组 & 干预措施
Intervention
Patients use tasteless and sugar free chewing gum up to 5 times a day for 1 month.
Daily registrations in a patient dairy.
干预措施: Chewing gum (Dietary Supplement)
Control
Patients continue with daily routine to relieve oral discomfort. No chewing gum allowed.
结局指标
主要结局
Salivary flow (intervention arm)
时间窗: 1 month
Patients in the intervention arm will experience increase in stimulated salivary flow at follow up as compared to unstimulated salivary flow at baseline.
次要结局
- Salivary flow (both groups of patients)(1 month)
研究者
Julie Killerup Kaae
M.D.
Odense University Hospital