| CTRI Number |
CTRI/2025/10/096737 [Registered on: 31/10/2025] Trial Registered Prospectively |
| Last Modified On: |
29/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study the acute and long term impact of head and neck cancer treatment involving surgery and adjuvant radiotherapy on autonomic function |
|
Scientific Title of Study
|
Acute and long term impact of head and neck cancer treatment on autonomic function |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mridul Rathi |
| Designation |
Senior Resident |
| Affiliation |
All India Institute Of Medical Sciences, New Delhi |
| Address |
ENT Department
All India Institute Of Medical Sciences, South Delhi
New Delhi
DELHI
110029
India |
| Phone |
9971760564 |
| Fax |
|
| Email |
mridulrathi0524@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Smriti Panda |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
All India Institute Of Medical Sciences, New Delhi |
| Address |
ENT Department
All India Institute Of Medical Sciences, South Delhi
New Delhi
DELHI
110029
India |
| Phone |
9717827306 |
| Fax |
|
| Email |
smriti.panda.87@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Smriti Panda |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
All India Institute Of Medical Sciences, New Delhi |
| Address |
ENT Department
All India Institute Of Medical Sciences, South Delhi
New Delhi
DELHI
110029
India |
| Phone |
9717827306 |
| Fax |
|
| Email |
smriti.panda.87@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute Of Medical Sciences, New Delhi |
|
|
Primary Sponsor
|
| Name |
All India Institute Of Medical Sciences, New Delhi |
| Address |
Sri Aurobindo Marg, Ansari Nagar , New Delhi 110029 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Mridul Rathi |
All India Institute Of Medical Sciences |
Room 4057, Department of Otorhinolaryngology and Head Neck Surgery, Teaching Block, 4th Floor, AIIMS, Ansari Nagar, Delhi 110029
South
DELHI |
9971760564
mridulrathi0524@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUE ETHICS COMMITTEE, AIIMS, NEW DELHI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-C14||Malignant neoplasms of lip, oral cavity and pharynx, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with histologically proven head
and neck cancer planned for curative intent
treatment.
2. The treatment plan should include surgery
and adjuvant treatment
3. Surgical intervention should include neck
dissection |
|
| ExclusionCriteria |
| Details |
1. Previously Known Hypertensive
2. Previously Known Diabetics
3. Comorbid illnesses with possibility of
autonomic dysfunction- Parkinson’s
Disease
4. Patient demonstrating local or loco-
regional recurrent disease in close
proximity of critical neuro-vascular
structures during follow-up AFT
assessment
5. Patients post total laryngectomy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Autonomic Function Tests
2. Carotid artery intimal thickening |
Both will be assessed at
Baseline, 4 weeks, 12 weeks, 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To determine extent of dysfunction for various components of Autonomic Function Tests
2. To determine the incidence and extent of intimal thickening, luminal narrowing and critical stenosis in the region of carotid sinus on ultrasound doppler performed at 1 year from the day of surgery
3. To assess the lymph node yield within the carotid triangle |
1 year |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
30/11/2025 |
| 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)
|
Not Yet Recruiting |
| 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
|
Multimodality treatment for head and neck cancer involves surgery followed by adjuvant treatment. Surgery includes wide excision of the primary tumor along with lymph nodal clearance. Head and neck is an anatomically complex region with numerous neurovascular structures located in close proximity like vagus nerve, sympathetic chain carotid bulb and baroreceptors which are important for cardiovascular autonomic control. Depending on the disease extension and need to obtain oncological clear margins, these structures may sustain varying degrees of deficit during neck dissection. Adjuvant radiation in the post op settings which usually causes intimal thickening, perivascular fibrosis and obliterative endarteritis could also lead to their temporary or permanent damage. This could manifest as orthostatic intolerance, labile blood pressure and blood pressure fluctuations. It is therefore crucial to evaluate the extent of autonomic dysfunction in these patients and to understand its mechanism to effectively manage and halt cardiovascular comorbidity from developing in future. A prospective analysis will be conducted at a tertiary cancer care center over a period of 2 years. All head and neck cancer patients who have been planned to be treated by surgery followed by adjuvant radiotherapy and are satisfying the inclusion and exclusion criteria will be included in the study. All patients will be evaluated clinic-radiologically for confirming the stage of the disease. After taking informed consent, they will undergo the following assessments at the below mentioned time points: 1. Autonomic function test which includes heart rate variability, deep breathing test, head up tilt test and hand grip test( Preoperative, 4 weeks post-surgery, 3 months post adjuvant radiation and 1 year post completion of treatment). 2. Ultrasound doppler of the carotid artery done at baseline and 1 year from start of treatment. Parameters to be assessed on ultrasound would be Intimal thickening, Presence of atheromatous plaque, Luminal narrowing, Presence of critical stenosis. 3. The fibrofatty tissue in the carotid triangle would be sent for histopathological analysis to determine the lymph node yield. |