| CTRI Number |
CTRI/2025/12/099382 [Registered on: 18/12/2025] Trial Registered Prospectively |
| Last Modified On: |
18/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Quality of Life in Head and Neck Cancer Participants After Neck Surgery, and Ultrasound Accuracy for Detecting hidden Lymph Node Spread. |
|
Scientific Title of Study
|
To study the quality of life in Head and Neck Squamous cell carcinoma patients undergoing neck node dissection, with secondary analysis of diagnostic accuracy and reliability of USG based Node-RADS in clinically N0 neck. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Avni Agrawal |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College , Manipal (MAHE) |
| Address |
Department of Otorhinolaryngology,Room No. 3 Kasturba Medical College Manipal, Madhavnagar, Manipal, Udupi, Karnataka -576104
Udupi
KARNATAKA
576104
India |
| Phone |
9810197684 |
| Fax |
|
| Email |
avniagrawal0501@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rohit Singh |
| Designation |
Professor and Head of the Department |
| Affiliation |
KASTURBA MEDICAL COLLEGE MANIPAL (MAHE) |
| Address |
Kasturba Medical College Manipal (MAHE), Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9900405817 |
| Fax |
|
| Email |
rohit.singh@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rakshita Samanth |
| Designation |
Assisttant Professor |
| Affiliation |
Kasturba Medical College , Manipal (MAHE) |
| Address |
Department of Otorhinolaryngology,Room No. 3 Kasturba Medical College Manipal, Madhavnagar, Manipal, Udupi, Karnataka -576104
Udupi
KARNATAKA
576104
India |
| Phone |
9964084896 |
| Fax |
|
| Email |
rakshitha.samanth@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
ICMR |
| Address |
V. Ramalingaswami Bhawan, P.O. Box No. 4911Ansari Nagar, New Delhi - 110029, India |
| Type of Sponsor |
Government funding agency |
|
|
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 Avni Agrawal |
Kasturba Medical College and Kasturba Hospital, Manipal (MAHE) |
Department of Otorhinolaryngology,Room No. 3 Kasturba Medical College Manipal, Madhavnagar, Manipal, Udupi, Karnataka -576104
Udupi
KARNATAKA |
09810197684
avniagrawal0501@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee-2 (Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C10||Malignant neoplasm of oropharynx, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Scheduled to receive neck dissection (along with surgical treatment of primary tumor)
Not received any neo-adjuvant treatment chemotherapy or radiotherapy
|
|
| ExclusionCriteria |
| Details |
Recurrent disease
Previous neck trauma, neck surgery, radiation to the neck
Neurological illness, congenital malformations of the neck
Cognitive impairment or inability to complete questionnaires
Known shoulder pathology
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
QoL changes after neck dissection after 1 month and 3 months of surgery
|
QoL changes after neck dissection after 1 month and 3 months of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Diagnostic Accuracy & reliability of USG guided FNAC after 10 days of surgery by correlating it with the final histopathology report |
Diagnostic Accuracy & reliability of USG guided FNAC after 10 days of surgery by correlating it with the final histopathology report |
|
|
Target Sample Size
|
Total Sample Size="97"
Sample Size from India="97"
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
|
N/A |
|
Date of First Enrollment (India)
|
31/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
31/12/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
HNSCC represents a significant proportion of
cancer burden in India, accounting for approximately 40% of all malignancies.
Neck dissection remains a vital component of curative treatment but is often
associated with long-term morbidity affecting overall QoL. Despite its
widespread use, there is limited prospective data in the Indian population
regarding post-operative QoL outcomes and their predictors. Additionally, while
Node-RADS is a novel radiological scoring system for lymph node assessment, its
diagnostic accuracy and clinical reliability, especially in clinically N0
necks, have not been thoroughly validated. This study will be the first study
to address these crucial gaps by evaluating both functional QoL outcomes and
the diagnostic performance of imaging tools like Node-RADS and USG-guided FNAC.
As the first prospective study of its kind in the Indian context, it has the
potential to standardize neck node evaluation protocols and enhance
individualized care, ultimately improving long-term outcomes and resource
utilization in oncology practice |