Phase III RCT comparing salivary flow rate of Transcutaneous Electrical Nerve Stimulation (TENS) versus Pilocarpine in patients who are receiving parotid sparing VMAT in Head and Neck Cancer patients
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To determine the difference in salivary flow rate between Transcutaneous Electrical Nerve Stimulation (TENS) and Pilocarpine in patients who are receiving parotid sparing Volumetric Modulated Arc Therapy (VMAT) in Head and Neck Cancer patients by sialometry
研究概览
简要总结
This study is a phase III randomised controlled trial comparing salivary flow rate of Transcutaneous Electrical Nerve Stimulation (TENS) receiving daily versus Pilocarpine 5mg PO TDS daily in patients who are receiving parotid sparing VMAT in Head and Neck Cancer patients that will be conducted in JIPMER RCC with a total sample size of 60 with intervention arm receiving TENS during the course of RT and control arm receiving 5 mg pilocarpine orally 3 times daily for the radiotherapy. Patient will be evaluated initially at baseline by sialometry, scintigraphy, XeQOLS questionnaire, ophthalmic examination (Tear film, IOP, Anterior chamber, Pupil size, Refractive errors). At 3rd week, 6th week during the course of radiation therapy, and at 6th week post completion of radiation therapy patient patient will be evaluated by sialometry and adverse effects will be assessed. At 3 months post completion of radiation therapy, Patient will be evaluated by scintigraphy. At 6 months post completion of radiation therapy, Patient will be evaluated by sialometry, scintigraphy, XeQOLS questionnaire, ophthalmic examination (Tear film, IOP, Anterior chamber, Pupil size, Refractive errors) and adverse effects will be assessed. We will continue to follow up the patient for long term outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •Patients over 18 years of age
- •Patients with ECOG performance status
- •Patients of squamous cell carcinoma of head and neck can- cer planned for Radical RT with or without concurrent chem- otherapy using parotid sparing VMAT.
排除标准
- •Patients with previous history of radiotherapy to head and neck
- •Patients with carcinoma of the head and neck in whom the salivary glands are involved by the disease
- •Pre-existing salivary gland disease
- •Patients with contraindications to pilocarpine or TENS were excluded. Contraindications to pilocarpine:.
- •clinically important uncontrolled cardiac, renal, and pulmonary disease.
- •ocular disease -Concurrent use of tricyclic antidepressants, antihistamines with anticholinergic effects, betablockers, pilocarpine eye preparations Contraindications to TENS: -Cardiac diseases -people with pacemaker or any electrical or metal implant -epilepsy, mental disorders -Pregnant.
结局指标
主要结局
To determine the difference in salivary flow rate between Transcutaneous Electrical Nerve Stimulation (TENS) and Pilocarpine in patients who are receiving parotid sparing Volumetric Modulated Arc Therapy (VMAT) in Head and Neck Cancer patients by sialometry
时间窗: At baseline, 3rd week, 6thweek during the course of radiation therapy, 6 weeks and 6 months post completion of radiation therapy
次要结局
- To determine whether Transcutaneous Electri-cal Nerve Stimulation (TENS) would reduce the overall radiation-induced xerostomia burden compared with oral pilocarpine measured by the University of Michigan Xerostomia Related Quality of Life Scale (XeQOLS)(At baseline and at 6 months post completion of radiation therapy)
- Incidence of adverse events of pilocarpine and Transcutaneous Electrical Nerve Stimulation (TENS) according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 criteria(At 3rd week, 6th week during the course of radiation therapy, 6 weeks and 6 months post completion of radia-tion therapy.)
- Relative change in excretion fraction by salivary scintigraphy(At baseline and at 3, 6 months post completion of radiation therapy)
- Secretion velocity by salivary scintigraphy(At baseline and at 3, 6 months post completion of radiation therapy.)
- Ophthalmic examination with measurement of Tear film, Intraocular Pressure (IOP), Anteri-or chamber depth, Pupil size, Refractive errors(At baseline and at 6 months post completion of radiation therapy.)
研究者
Gobburi Sudha Rani
Jawaharlal Institute of Postgraduate Medical Education and Research