| 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 |
|
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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
|
|
|
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
|
|
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, |
|
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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. |
|
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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. |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
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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 |
|
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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. |