Laser Acupoints Stimulation on Xerostomia Related Chemoradiotherapy for Head and Neck Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Xerostomia Inventory score
研究概览
简要总结
The purpose of the study is to evaluate to effect of LASER acupoints stimulations on xerostomia patients during chemoradiation therapy after head and neck cancer.
详细描述
The current diagnosis is based on the primary complaint reported by the patient. A previous study found that patients with cancer reported different degrees of dry mouth, reduced drinking and eating and waking up at night due to dry mouth and that the risk of progression to oral ulcers was higher among this patient population and could significantly affect the quality of life.
Acupuncture may be effective in treating xerostomia and also, acupuncture has been shown to increase salivary flow in healthy volunteers.
As xerostomia gradually comes to the attention of the wider medical community, clinical evidence is slowly starting to amass to help assess which treatments are most effective, but more research is needed. Furthermore, there is a lack in the quantitative knowledge and information in the published studies about benefits of acupuncture on xerostomia during chemo radiation therapy. So, this study is designed to outline the therapeutic efficacy of acupuncture on xerostomia during chemo radiation therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chemoradiation therapy
- •Carcinoma in the head and neck area (NPC)
- •Anatomically intact parotid and submandibular glands.
- •All patients will be clinically and medically stable when attending the study.
排除标准
- •They had a history of xerostomia;
- •They had suspected or confirmed physical closure of salivary gland.
- •ducts on either side.
- •They had known bleeding disorders.
- •They Were taking heparin or warfarin.
- •They had contraindications for the use of acupuncture at any acupoints.
- •They had history of cerebrovascular accident or spinal cord injury.
- •They had taken any drug or herbal medicine in the past 30 days that could affect salivary function.
- •They were planning to, or ended up taking such a substance during the study.
- •Any therapy that may affect treatment.
研究组 & 干预措施
LASER acupoints therapy + Medical treatment
This group will include twenty-seven patients suffering xerostomia (dryness of mouth), who will receive LASER acupoints therapy (3 times per week, for 4 weeks), plus medical treatment.
干预措施: Medical treatment (Other)
LASER acupoints therapy + Medical treatment
This group will include twenty-seven patients suffering xerostomia (dryness of mouth), who will receive LASER acupoints therapy (3 times per week, for 4 weeks), plus medical treatment.
干预措施: LASER acupoints therapy (Other)
Pseudo-LASER acupoints therapy + Medical treatment
This group will include twenty-seven patients suffering xerostomia (dryness of mouth), who will receive pseudo-LASER acupoints therapy plus medical treatment (for 4 weeks).
干预措施: Medical treatment (Other)
Pseudo-LASER acupoints therapy + Medical treatment
This group will include twenty-seven patients suffering xerostomia (dryness of mouth), who will receive pseudo-LASER acupoints therapy plus medical treatment (for 4 weeks).
干预措施: Pseudo-LASER acupoints therapy (Other)
结局指标
主要结局
Xerostomia Inventory score
时间窗: 4 weeks
Participants will complete the Xerostomia Inventory (XI) questionnaire, a validated tool measuring the subjective burden of dry mouth. It consists of 11 items covering symptoms such as dryness of the mouth, lips, eyes, nose, and face, difficulty with dry foods, sipping liquids, sucking sweets, and nighttime thirst. Responses are rated on a 5-point Likert scale from Never (1) to Very Often (5). Total scores are converted to a 0-10 scale, where 0 represents no burden and 10 indicates an excruciating burden. The questionnaire will be administered at baseline and post-treatment.
次要结局
- Stimulated salivary flow rate (SSFR) by Sialometry(4 weeks)
研究者
Nehal Gamal Ebrahim Elwerish
Principal Investigator
Cairo University