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临床试验/CTRI/2014/03/004475
CTRI/2014/03/004475已完成2 期

EVALUATION OF EFFECTIVENESS OF TRANSCUTANEOUS ELECTRIC NERVE STIMULATION (TENS) THERAPY ON SALIVA PRODUCTION IN POSTRADIATION ORAL CANCER PATIENTS.

Malabar Cancer Center1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2013年1月6日最近更新:

试验速览

阶段
2 期
状态
已完成
入组人数
30
试验地点
1
主要终点
Improvement in saliva outflow measured in ml/min

研究概览

简要总结

Saliva is a critical fluid necessary for oral health. Xerostomia is the subjective complaint of oral dryness with an objective decrease in salivary volume. The major causes of xerostomia are medications, radiation therapy of head and neck cancers and autoimmune disorders like Sjogrens syndrome.

A substantial decrease in salivary function has significant impact on quality of life and results in increased burden of long term dental care. Systemic agents like pilocarpine stimulate salivary flow but have many contraindications and unfavourable side effects.

Augmentation of salivary reflexes through application of an electrical stimulus has been reported to increase salivary flow and alleviate xerostomia in patients after radiotherapy to head and neck, without local or systemic side effects. The purpose of this study is to evaluate the effectiveness of TENS therapy in stimulating salivation in postradiated oral cancer patients.

This study is planned as a pilot study to gain baseline data about the efficacy of TENS in patients with Xerostomia after radiotherapy. In a study involving 50 patients with xerostomia Mittal et al had shown that salivary output can increase by 0.045 ± 0.02 ml/min after application of TENS.  Since our study population was containing patients post radiotherapy we expected the increase to be much lesser. Using the paired difference model a sample size of 25 at an alpha of 0.01 has a power of 80% to detect an increase of 0.015 ml/min after application of TENS with a standard deviation of difference of 0.02 ml/min. In order to account for potential incompliance the sample size is increased to 30.

Results:

29 out of 30 patients demonstrated increased saliva flow during stimulation. A statistically significant improvement in saliva production (P<0.05) during stimulation was noted. Mean unstimulated saliva flow was 0.056ml/min and mean stimulated saliva flow was 0.12ml/min with a median increase of 0.06ml/min. Interval to application of TENS after radiotherapy significantly influenced the improvement in salivary flow.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • Age > 18 years
  • Oral cancer patients, undergone radiation therapy as part of their treatment plan.

排除标准

  • Patients with pacemakers and cochlear implants.
  • Patients with a history of salivary gland pathology.
  • Pregnant patients.
  • Patients with systemic illness.
  • Patients with autoimmune disorders.

结局指标

主要结局

Improvement in saliva outflow measured in ml/min

时间窗: Improvement in saliva outflow measured in ml/min after 5 minutes of TENS application

次要结局

  • Correlation between salivary outflow and parotid doses(At time of TENS application)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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