Comparative effectiveness of Low- Level Laser Therapy(810nm) and 2% citric acid solution in Prevention of radiotherapy-induced Xerostomia.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Stimulated and unstimulated whole saliva flow rate
研究概览
简要总结
This study aims to compare the efficacy of low-level laser therapy and a 2% citric acid solution as mouth rinses in preventing radiotherapy-induced xerostomia in cancer patients. The research will involve a randomized control trial with a concurrent parallel design, utilizing a sample size of 20 in each group through simple randomized sampling. The low-level laser, with specific parameters, will be applied three times a week before and after radiotherapy sessions. The control group will receive a 2% citric acid solution as a mouth rinse. Salivary flow rates will be assessed through unstimulated and stimulated sialometry tests at various time points during and after radiotherapy, using established norms. Additionally, the 11-item modified Xerostomia Inventory-Dutch questionnaire will be employed to measure the severity of dry mouth symptoms. The study aims to evaluate and compare the effectiveness of both interventions in reducing radiation-induced xerostomia, providing valuable insights into potential preventive measures for this common side effect in head and neck cancer patients undergoing radiotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Histologically proven squamous cell carcinoma of head and neck.
- •Patients treated with upfront rÌ¥adio- therapy or chemo-radiotherapy with curative intent.
- •Patients of both gender and between 18 years to 70 years of age.
排除标准
- •Systemic condition with hyposalivation e.g. DM, End stage renal disease etc.
- •Autoimmune diseases such as Sjogren Syndrome by established diagnosis criteria.
- •Infectious diseases iv.
- •Collagen diseases, as were those with incipient tumors (stage T1 or T2) limited to the larynx, as well as those with trismus (reduced mouth opening capacity) due to surgical sequelae.
- •Already on xerostomic drugs (antiretroviral medications, antihistamines, anticholinergics, antihypertensives, decongestants, narcotic analgesics, tricyclic antidepressants).
结局指标
主要结局
Stimulated and unstimulated whole saliva flow rate
时间窗: baeline | 3 week | end of RT | 3 month of completion of RT
次要结局
- 11-item modified Xerostomia Inventory-Dutch questionnaire version(before therapy and end of the therapy)
研究者
Dr Sakshi Batra
Banaras Hindu University