Controlled Trial Of Acupuncture To Prevent Radiation-Induced Xerostomia
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 435
- 试验地点
- 2
- 主要终点
- Self-Reported Xerostomia Symptoms Using the Xerostomia Questionnaire (XQ)
研究概览
简要总结
The goal of this clinical research study is to learn if acupuncture can help to prevent xerostomia (dry mouth) and improve the quality of life in patients who receive radiation treatment to the head and neck. This study will determine if one acupuncture treatment approach is more effective than another. Dry mouth is a common problem among cancer patients who have received radiation treatment to the head and neck.
详细描述
Acupuncture is a technique that may treat symptoms by inserting very thin, solid, sterile, stainless steel needles into the skin at specific points.
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the roll of a dice) into 1 of 3 groups.
Group 1 will receive acupuncture during the radiation treatment period.
Group 2 will receive acupuncture at different points on the body than those in Group 1 during the radiation treatment period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Single (Participant)
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
- •18 years of age and be able to give informed consent.
- •Diagnosed with head and neck cancer, which will be primarily oropharyngeal, and scheduled to undergo IMRT with or without concurrent chemotherapy at M. D. Anderson.
- •Treatment plan that includes external beam radiation at a mean dose of at least 24 Gy or more to one of the parotid glands (the other gland can receive less than 24 Gy).
- •Anatomically intact parotid and submandibular glands.
- •Karnofsky performance status > 60.
排除标准
- •History of xerostomia prior to head and neck radiation therapy or history of Sjögren's disease or another underlying systemic illness known to cause xerostomia.
- •Prior head and neck radiation treatment.
- •Suspected or confirmed physical closure of salivary gland ducts on either side.
- •Known bleeding disorders or taking any dose of warfarin or heparin.
- •Upper or lower extremity deformities that could interfere with accurate acupoint location or alter the energy pathway as defined by traditional acupuncture theory.
- •Local skin infections at or near the acupuncture sites or active systemic infection.
- •History of cerebrovascular accident or spinal cord injury since the mechanism of acupuncture may be associated with central nervous system activity.
- •Mental incapacitation or significant emotional or psychiatric disorder that, in the opinion of the investigator, precludes study entry as these patients may not be able to cooperate with this slightly invasive procedure or with the data collection process.
- •Current acknowledged use of any illicit drugs or evidence of alcohol abuse as defined by The American Psychiatric Association criteria.
- •Current acknowledged use of amifostine, cholinergic agonist medications (pilocarpine, cevimeline), certain beta adrenergic antagonists, anticholinergic agents, or any saliva substitute or other medication/herbal preparation known to affect salivary function (see Appendix F).
- •Patients who are currently receiving acupuncture for any condition or if they have ever had acupuncture before.
研究组 & 干预措施
Acupuncture - Group 1
Acupuncture at 14 points. The needles will remain in place for 20 minutes with each treatment. Questionnaires - Baseline assessments will be completed within 7 days prior to starting radiotherapy, and patients will then complete the same assessments again at week 4 and 7 of radiotherapy and 3, 6, and 12 months after the end of radiotherapy.
干预措施: Acupuncture - Group 1 (Procedure)
Acupuncture - Group 1
Acupuncture at 14 points. The needles will remain in place for 20 minutes with each treatment. Questionnaires - Baseline assessments will be completed within 7 days prior to starting radiotherapy, and patients will then complete the same assessments again at week 4 and 7 of radiotherapy and 3, 6, and 12 months after the end of radiotherapy.
干预措施: Standard Care (Other)
Acupuncture - Group 1
Acupuncture at 14 points. The needles will remain in place for 20 minutes with each treatment. Questionnaires - Baseline assessments will be completed within 7 days prior to starting radiotherapy, and patients will then complete the same assessments again at week 4 and 7 of radiotherapy and 3, 6, and 12 months after the end of radiotherapy.
干预措施: Questionnaire (Other)
Acupuncture - Group 2
Acupuncture needles placed at different points from Group 1. The needles will remain in place for 20 minutes with each treatment. Questionnaires - Baseline assessments will be completed within 7 days prior to starting radiotherapy, and patients will then complete the same assessments again at week 4 and 7 of radiotherapy and 3, 6, and 12 months after the end of radiotherapy.
干预措施: Acupuncture - Group 2 (Procedure)
Acupuncture - Group 2
Acupuncture needles placed at different points from Group 1. The needles will remain in place for 20 minutes with each treatment. Questionnaires - Baseline assessments will be completed within 7 days prior to starting radiotherapy, and patients will then complete the same assessments again at week 4 and 7 of radiotherapy and 3, 6, and 12 months after the end of radiotherapy.
干预措施: Standard Care (Other)
Acupuncture - Group 2
Acupuncture needles placed at different points from Group 1. The needles will remain in place for 20 minutes with each treatment. Questionnaires - Baseline assessments will be completed within 7 days prior to starting radiotherapy, and patients will then complete the same assessments again at week 4 and 7 of radiotherapy and 3, 6, and 12 months after the end of radiotherapy.
干预措施: Questionnaire (Other)
Standard Care
Standard oral care recommendations. Participants in all groups will receive the same recommendations. Questionnaires - Baseline assessments will be completed within 7 days prior to starting radiotherapy, and patients will then complete the same assessments again at week 4 and 7 of radiotherapy and 3, 6, and 12 months after the end of radiotherapy.
干预措施: Standard Care (Other)
Standard Care
Standard oral care recommendations. Participants in all groups will receive the same recommendations. Questionnaires - Baseline assessments will be completed within 7 days prior to starting radiotherapy, and patients will then complete the same assessments again at week 4 and 7 of radiotherapy and 3, 6, and 12 months after the end of radiotherapy.
干预措施: Questionnaire (Other)
结局指标
主要结局
Self-Reported Xerostomia Symptoms Using the Xerostomia Questionnaire (XQ)
时间窗: 4 weeks
Xerostomia Questionnaire (XQ), an 8-item questionnaire where subjects rate each symptom on an 11-point ordinal Likert scale from 0 to 10, with higher scores indicating greater dryness or discomfort due to dryness.
次要结局
未报告次要终点