FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/10/074850 [Registered on: 07/10/2024] Trial Registered Prospectively
Last Modified On: 06/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Medical Device
Radiation Therapy
Preventive 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   This study is a clinical trial comparing salivary gland function by measuring the salivary flow rate in patients of head and cancer on parotid sparing radiotherapy using VMAT technique who are receiving either Transcutaneous Electric Nerve Stimulation (TENS) or pilocarpine 
Scientific Title of Study   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 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
JIP/D(R)/IECIS-5/0724/84 version 1.1 dated 05/08/2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Gobburi Sudha Rani  
Designation  PG student 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research  
Address  Radiation oncology, Regional Cancer Centre, Jawaharlal Institute of Postgraduate Medical Education and Research
JIPMER Campus Rd, Gorimedu, Dhanvantari Nagar
Pondicherry
PONDICHERRY
605006
India 
Phone  9959605806  
Fax    
Email  gsudharani11@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Gunaseelan K 
Designation  Professor 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research  
Address  Radiation oncology, Regional Cancer Centre, Jawaharlal Institute of Postgraduate Medical Education and Research
JIPMER Campus Rd, Gorimedu, Dhanvantari Nagar
Pondicherry
PONDICHERRY
605006
India 
Phone  9362966444  
Fax    
Email  gunapgi@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr. Gunaseelan K 
Designation  Professor 
Affiliation  awaharlal Institute of Postgraduate Medical Education and Research  
Address  Radiation oncology, Regional Cancer Centre, Jawaharlal Institute of Postgraduate Medical Education and Research
JIPMER Campus Rd, Gorimedu, Dhanvantari Nagar
Pondicherry
PONDICHERRY
605006
India 
Phone  9362966444  
Fax    
Email  gunapgi@gmail.com  
 
Source of Monetary or Material Support  
JIPMER Intramural Research Fund, Jawaharlal Institute of Postgraduate Medical Education and Research, JIPMER Campus Rd, Gorimedu, Dhanvantari Nagar, Pondicherry, India, Pincode: 605006 
 
Primary Sponsor  
Name  IMRF FUND, JIPMER 
Address  Jawaharlal Institute of Postgraduate Medical Education and Research JIPMER Campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry, 605006. 
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 
Gobburi Sudha Rani   Jawaharlal Institute of Postgraduate Medical Education and Research  Radiation oncology, Regional Cancer Centre, Jawaharlal Institute of Postgraduate Medical Education and Research, JIPMER Campus Rd, Gorimedu, Dhanvantari Nagar
Pondicherry
PONDICHERRY 		 9959605806

gsudharani11@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JIPMER INSTITUTIONAL ETHICS COMMITTEE INTERVENTIONAL STUDIES  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C01||Malignant neoplasm of base of tongue, (2) ICD-10 Condition: C130||Malignant neoplasm of postcricoidregion, (3) ICD-10 Condition: C131||Malignant neoplasm of aryepiglottic fold, hypopharyngeal aspect, (4) ICD-10 Condition: C132||Malignant neoplasm of posterior wall of hypopharynx, (5) ICD-10 Condition: C138||Malignant neoplasm of overlappingsites of hypopharynx, (6) ICD-10 Condition: C139||Malignant neoplasm of hypopharynx,unspecified, (7) ICD-10 Condition: C12||Malignant neoplasm of pyriform sinus, (8) ICD-10 Condition: C110||Malignant neoplasm of superior wall of nasopharynx, (9) ICD-10 Condition: C111||Malignant neoplasm of posterior wall of nasopharynx, (10) ICD-10 Condition: C112||Malignant neoplasm of lateral wallof nasopharynx, (11) ICD-10 Condition: C113||Malignant neoplasm of anterior wall of nasopharynx, (12) ICD-10 Condition: C118||Malignant neoplasm of overlappingsites of nasopharynx, (13) ICD-10 Condition: C119||Malignant neoplasm of nasopharynx,unspecified, (14) ICD-10 Condition: C100||Malignant neoplasm of vallecula, (15) ICD-10 Condition: C101||Malignant neoplasm of anterior surface of epiglottis, (16) ICD-10 Condition: C102||Malignant neoplasm of lateral wallof oropharynx, (17) ICD-10 Condition: C103||Malignant neoplasm of posterior wall of oropharynx, (18) ICD-10 Condition: C104||Malignant neoplasm of branchial cleft, (19) ICD-10 Condition: C108||Malignant neoplasm of overlappingsites of oropharynx, (20) ICD-10 Condition: C109||Malignant neoplasm of oropharynx,unspecified, (21) ICD-10 Condition: C090||Malignant neoplasm of tonsillar fossa, (22) ICD-10 Condition: C000||Malignant neoplasm of external upper lip, (23) ICD-10 Condition: C001||Malignant neoplasm of external lower lip, (24) ICD-10 Condition: C002||Malignant neoplasm of external lip, unspecified, (25) ICD-10 Condition: C003||Malignant neoplasm of upper lip, inner aspect, (26) ICD-10 Condition: C004||Malignant neoplasm of lower lip, inner aspect, (27) ICD-10 Condition: C005||Malignant neoplasm of lip, unspecified, inner aspect, (28) ICD-10 Condition: C006||Malignant neoplasm of commissure of lip, unspecified, (29) ICD-10 Condition: C008||Malignant neoplasm of overlappingsites of lip, (30) ICD-10 Condition: C009||Malignant neoplasm of lip, unspecified, (31) ICD-10 Condition: C01||Malignant neoplasm of base of tongue, (32) ICD-10 Condition: C020||Malignant neoplasm of dorsal surface of tongue, (33) ICD-10 Condition: C021||Malignant neoplasm of border of tongue, (34) ICD-10 Condition: C022||Malignant neoplasm of ventral surface of tongue, (35) ICD-10 Condition: C023||-2146826259, (36) ICD-10 Condition: C024||Malignant neoplasm of lingual tonsil, (37) ICD-10 Condition: C028||Malignant neoplasm of overlappingsites of tongue, (38) ICD-10 Condition: C029||Malignant neoplasm of tongue, unspecified, (39) ICD-10 Condition: C030||Malignant neoplasm of upper gum, (40) ICD-10 Condition: C031||Malignant neoplasm of lower gum, (41) ICD-10 Condition: C039||Malignant neoplasm of gum, unspecified, (42) ICD-10 Condition: C040||Malignant neoplasm of anterior floor of mouth, (43) ICD-10 Condition: C041||Malignant neoplasm of lateral floor of mouth, (44) ICD-10 Condition: C048||Malignant neoplasm of overlappingsites of floor of mouth, (45) ICD-10 Condition: C049||Malignant neoplasm of floor of mouth, unspecified, (46) ICD-10 Condition: C050||Malignant neoplasm of hard palate, (47) ICD-10 Condition: C051||Malignant neoplasm of soft palate, (48) ICD-10 Condition: C052||Malignant neoplasm of uvula, (49) ICD-10 Condition: C058||Malignant neoplasm of overlappingsites of palate, (50) ICD-10 Condition: C059||Malignant neoplasm of palate, unspecified, (51) ICD-10 Condition: C060||Malignant neoplasm of cheek mucosa, (52) ICD-10 Condition: C061||Malignant neoplasm of vestibule ofmouth, (53) ICD-10 Condition: C062||Malignant neoplasm of retromolar area, (54) ICD-10 Condition: C068||Malignant neoplasm of overlappingsites of other and unspecified parts of mouth, (55) ICD-10 Condition: C069||Malignant neoplasm of mouth, unspecified, (56) ICD-10 Condition: C091||Malignant neoplasm of tonsillar pillar (anterior) (posterior), (57) ICD-10 Condition: C098||Malignant neoplasm of overlappingsites of tonsil, (58) ICD-10 Condition: C099||Malignant neoplasm of tonsil, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Pilocarpine  Head and neck cancer patients on Parotid sparing VMAT receiving Pilocarpine daily during the course of RT. Patients will receive 5 mg pilocarpine orally 3 times daily for the entire course of radiotherapy and then will be stopped for the rest of the study. There will be no make-up for missed dose. Dose modification will be permitted in cases of pilocarpine intolerance. Patients who will complete drug diaries will return all medications for counting to determine treatment compli-ance and a log of adverse effects will be kept  
Intervention  Transcutaneous Electrical Nerve Stimulation (TENS)  Head and neck cancer patients on Parotid sparing VMAT receiving TENS daily during the course of RT. Patients who are receiving TENS will be informed to refrain from eating, drinking, chewing gum, and oral hygiene procedures for at least 1 h before the appointment. The electrode pads will be placed externally on the skin, 1 cm in front of the tragus of the ear, over the parotid region with the TENS unit in the off position. The TENS unit will be then activated and the intensity control switch will be adjusted for patient comfort by turning up one increment at a time, at 5 s intervals until the optimal intensity level will reach, which will be indicated by the patient by raising their hand. Optimal intensity is defined as the maximum intensity that the subject still perceived to be comfortable. After the completion of treatment, the TENS machine will be turned off completely and a log of adverse effects will be kept.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Patients over 18 years of age
2. Patients with ECOG performance status 0 - 2
3. 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 
 
ExclusionCriteria 
Details  1. Patients with previous history of radiotherapy to head and neck
2. Patients with carcinoma of the head and neck in whom the salivary glands are involved by the disease
3. Pre-existing salivary gland disease
4. 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 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
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  At baseline, 3rd week, 6thweek during the course of radiation therapy, 6 weeks and 6 months post completion of radiation therapy 
 
Secondary Outcome  
Outcome  TimePoints 
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. 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   21/10/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

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.

 
Close