Effect of Low Level Laser Therapy on Prevention of Radiotherapy Induced Xerostomia in Cancer Patients.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Unstimulated and stimulated salivary flow rate.
研究概览
简要总结
The purpose of the study is to evaluate the effectiveness of low level laser on radiotherapy induced xerostomia to improve oral function and decrease oral complication due to hyposalivation and thus enhancing survival.
详细描述
In this part of the study, the materials and methods will be presented under the following headings: subjects, equipment, procedures of the study and the statistical procedures.
- Subjects:
Sixty patients who have head and neck cancer (oral cavity, pharynx, larynx, or occult primary tumor) submitted to conventional 3D radiotherapy, with irradiation fields necessarily encompassing all major salivary glands. The total dose ranged from 66 to 70 Gy, given in fractions of 2 Gy/day selected randomly from Nuclear medicine department, Oncology institute, Mansoura University.
These patients will be divided randomly into two groups of equal number, thirty patients for each group.
Group A: (Laser group) This group of patients composes of thirty patients who will receive GaAlAs laser three times a week, on alternate day (48h interval) Laser therapy will be initiated before the first radiotherapy session and ended after the last session, totaling 21 sessions (Fernanda A. S.G. et al., 2016).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
The participants are head and neck cancer patients recieving radiotherapy. The care provider are oncologist and nursing stuff. The investigator is phsical therapist (my self)
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Age range between 25-55 years.
- •All patients included in the study established HNC and will receive radiotherapy encompassing major salivary glands accompanied or not by surgery.
- •All patients enrolled to the study will have their informed consent.
- •Both genders will participate in the study.
- •All the patients were examined medically by oncologist
排除标准
- •- Diabetes mellitus,
- •Autoimmune diseases as sjorgen syndrome by established diagnosis criteria.
- •Infectious diseases
- •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.
- •xerostomic drugs (antiretroviral medications, antihistamines, anticholinergics, antihypertensives, decongestants, narcotic analgesics, tricyclic antidepressants)
研究组 & 干预措施
Laser group
Laser group composes of thirty patients who will receive low level laser three times a week, on alternate day (48h interval) Laser therapy will be initiated before the first radiotherapy session and ended after the last session, totaling 21 sessions
干预措施: low level laser (Device)
Laser group
Laser group composes of thirty patients who will receive low level laser three times a week, on alternate day (48h interval) Laser therapy will be initiated before the first radiotherapy session and ended after the last session, totaling 21 sessions
干预措施: citric acid solution (Drug)
Control group
control group composes of thirty patients will be treated with 15mL of a 2% citric acid solution applied as a mouth rinse for 30 sec
干预措施: citric acid solution (Drug)
结局指标
主要结局
Unstimulated and stimulated salivary flow rate.
时间窗: 7 weeks
For the assessment of salivary flow rate, unstimulated and stimulated sialometry tests will be performed before the first radiotherapy session and after completion of laser programe. As salivary secretion fluctuates between minimal and maximal rates during the day, it is important to assess the salivary secretion consistently at an established time of the day, in order to properly examine the evolution of the condition and its treatment in every patient. The normal flow rate for unstimulated, "resting" whole saliva is 0.3 to 0.5 ml/min.; for stimulated saliva, 1 to 2 ml/min. Values less than 0.1 ml/min. are typically considered xerostomic, although reduced flow may not always be associated with complaints of dryness
次要结局
- Salivary immunoglobin A (sIgA) concentration in unstimulated saliva.(7weeks)
研究者
Nada Yousef
Assistant lecturer of physical therapy, cairouniversity
Cairo University