Evaluation of Two Mouth Sprays for Post-irradiation Xerostomia in Head and Neck Cancer Survivors: a Randomized, Double-blind Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 129
- 试验地点
- 4
- 主要终点
- Oral Dryness
研究概览
简要总结
To identify the effectiveness of two mouth sprays at relieving symptoms of xerostomia in patients who have received radiation for carcinoma of the head and neck.
To assess patient quality of life and mouth acidity following use of two mouth sprays meant to relieve symptoms of xerostomia in patients who have received radiation for carcinoma of the head and neck.
详细描述
Investigators have observed that patients at the University of Pittsburgh Medical Center Head and Neck Survivorship clinic with symptoms of radiation-induced xerostomia expressed verbal preference for Biotene and Refresh mouth sprays (spray form of mouthwash) compared to other oral products such as gel, toothpaste, and chewing gum. Investigators have designed this study to specifically assess the effectiveness of mouth sprays on xerostomia in patients who have completed radiation for head and neck carcinoma. While there have been clinical trials to evaluate the effectiveness of Biotene oral products for xerostomia, Refresh mouthwash/mouth spray is a newer oral rinse formula that has not undergone any randomized controlled trials to evaluate its efficacy compared to other agents of its kind. The investigators have put forward this randomized controlled trial to compare the efficacy of both sprays to each other and to water. Biotene spray is cleared by the FDA as a medical device product. Currently, Refresh mouth spray falls under the FD&C Act.
There is preliminary data on the effectiveness of Biotene mouthwash for xerostomia in patients who have had radiation of the head and neck. A phase II study of Biotene products (mouthwash, chewing gum, and toothpaste) were effective at improving many symptoms of post-irradiation xerostomia. Numerous other studies have shown that mouthwash and topical dry mouth products improve xerostomia symptoms.
Xerostomia, or mouth dryness, is a frequent side effect of head and neck cancer radiation therapy, as the salivary glands are often damaged during therapy. Radiation therapy can be successful in treating cancer, but post-irradiation xerostomia can cause oral discomfort as well as issues with eating, speech, and oral hygiene, leading to significantly decreased quality of life. While treatment of xerostomia has limited benefit, various mouthwashes have led to major symptomatic improvement in some patients. This study will add to existing literature by commenting on efficacy of a popular and established mouth spray used for xerostomia as well as a new mouth spray that has not been compared to existing formulas. A double-blinded randomized controlled trial evaluating these mouth sprays will add information about value of both formulas for head and neck carcinoma survivors with radiation-induced xerostomia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Both subjects and clinicians will be blinded to Mouth Spray A and Mouth Spray B.
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
- •biopsy-proven oral cavity, oropharynx, larynx, and hypopharynx carcinoma
- •who received primary radiation with curative intent (>50 Gray in 20 fractions)
- •radiation treatment completed greater than 6 months ago
- •who endorse xerostomia
排除标准
- •evidence of metastasis or recurrent disease
- •Current use of pilocarpine, antidepressants, anticholinergic drugs, or any other medication that has an effect on salivation
- •those who have documented medical conditions associated with xerostomia such as Sjogren's Syndrome
- •those who use oral inhalants for the treatment of respiratory disease
结局指标
主要结局
Oral Dryness
时间窗: 2 week trial period
at the end of each study period an online questionnaire was administered. The questionnaire included continuous variables derived from the 100mm visual analog scale (VAS); documented via questionnaire completion by participants administered via Qualtrics. Dryness was measured on a 0-100 point scale "During the last three days, overall, your mouth or tongue was: 'Very Dry' = 0 10 20 30 40 50 60 70 80 90 100 = 'Not at All Dry"
次要结局
- Speaking Difficulty Due to Oral Dryness(2 week trial)
- Sleeping Difficulty Due to Oral Dryness(2 week trial)
- Taste Alteration/Impairment Due to Oral Dryness(2 week trial)
- Swallowing and Chewing Difficulty Due to Oral Dryness(2 week trial)
- Saliva PH(2 week trial)
- Difficulty Wearing Dental Prostheses (if Applicable)(6 weeks)
研究者
Jonas Johnson
Principal Investigator
University of Pittsburgh
