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CTRI Number  CTRI/2014/03/004475 [Registered on: 13/03/2014] Trial Registered Retrospectively
Last Modified On: 15/07/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Physiotherapy (Not Including YOGA) 
Study Design  Single Arm Study 
Public Title of Study   Effectiveness of TENS in reducing dryness of mouth in patients who have received radiotherapy 
Scientific Title of Study   EVALUATION OF EFFECTIVENESS OF TRANSCUTANEOUS ELECTRIC NERVE STIMULATION (TENS) THERAPY ON SALIVA PRODUCTION IN POSTRADIATION ORAL CANCER PATIENTS.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anu Vijayan 
Designation  Post Graduate Trainee 
Affiliation  Sri Hasanamba Dental College & Hospital 
Address  Dept of Oral Medicine & Radiology, Sri Hasanamba Dental College & Hospital, Hassan, Karnataka

Hassan
KARNATAKA
573201
India 
Phone  8050350213  
Fax    
Email  dranuomr@yahoo.in  
 
Details of Contact Person
Scientific Query
 
Name  Santam Chakraborty 
Designation  Associate Professor 
Affiliation  Malabar Cancer Center 
Address  Department of Radiation Oncology, Malabar Cancer Center, Thalassery, Kerala

Kannur
KERALA
670103
India 
Phone  9544546627  
Fax    
Email  drsantam@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Santam Chakraborty 
Designation  Associate Professor 
Affiliation  Malabar Cancer Center 
Address  Department of Radiation Oncology, Malabar Cancer Center, Thalassery, Kerala

Kannur
KERALA
670103
India 
Phone  9544546627  
Fax    
Email  drsantam@gmail.com  
 
Source of Monetary or Material Support  
Malabar Cancer Center, Thalassery, Kerala 
 
Primary Sponsor  
Name  Malabar Cancer Center 
Address  Malabar Cancer Center, Thalassery, Kerala 670103 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sateeshan Balasubramanian  Malabar Cancer Center  Malabar Cancer Center, Thalassery
Kannur
KERALA 
04902355881
04902355880
directormcctly@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Malabar Cancer Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Head Neck Squamous Cell cancers after Radiotherapy, (1) ICD-10 Condition: C14||Malignant neoplasm of other and ill-defined sites in the lip, oral cavity and pharynx,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  Transcutaneous Electrical Nerve Stimulation  The TENS machine used for the study is MEDIHIGHTEC 8000 combo (MEDIHIGHTEC medical CO.LTD, Taiwan). The settings of the TENS machine are as follows: 1. Pulse rate 50 Hz 2. Pulse duration 250uS 3. Time : 5 minutes 4. Normal mode The electrode pads are placed externally on the skin, 1cm in front of tragus of ear, over the parotid region with the TENS unit in the off position The patient is asked to sit in an upright position with head bend down and allow saliva to drool into the measuring cup with “low force spit” method. The TENS unit is then activated and the intensity control switch is adjusted for patient comfort by turning up 1 increment at a time, at 5 second intervals until the optimal intensity level is reached which is indicated by patient by raising his/her hand. Optimal intensity is defined as the maximum intensity that the subject still perceived to be comfortable. Stimulated saliva is then collected for 5 minutes into a separate calibrated cup. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1. Age > 18 years
2. Oral cancer patients, undergone radiation therapy as part of their treatment plan. 
 
ExclusionCriteria 
Details  1. Patients with pacemakers and cochlear implants.
2. Patients with a history of salivary gland pathology.
3. Pregnant patients.
4. Patients with systemic illness.
5. Patients with autoimmune disorders.
6. Patients on antidepressant therapy. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improvement in saliva outflow measured in ml/min  Improvement in saliva outflow measured in ml/min after 5 minutes of TENS application 
 
Secondary Outcome  
Outcome  TimePoints 
Correlation between salivary outflow and parotid doses  At time of TENS application 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "25"
Final Enrollment numbers achieved (India)="25" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   01/06/2013 
Date of Study Completion (India) 10/07/2013 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 10/07/2013 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
http://www.ncbi.nlm.nih.gov/pubmed/25262845 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

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.

 
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