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CTRI Number  CTRI/2025/02/080769 [Registered on: 18/02/2025] Trial Registered Prospectively
Last Modified On: 16/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   ambispective analytical 
Study Design  Other 
Public Title of Study   Trial to assess the impact of sarcopenia in oral cavity squamous cell carcinoma patients 
Scientific Title of Study   Impact of sarcopenia on oncological outcomes in oral cavity squamous cell carcinoma patients undergoing surgery An ambispective study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rosy Saikia 
Designation  Senior Resident 
Affiliation  All India Institute Of Medical Sciences 
Address  All India Institute of Medical sciences, New Delhi
Department of Otorhinolaryngology and head and neck surgery
New Delhi
DELHI
110029
India 
Phone  9508679525  
Fax    
Email  rosysaikia.2822@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof Amit Chirom 
Designation  Professor 
Affiliation  All India Institute Of Medical Sciences 
Address  Department of ENT, All India Institute of medical sciences, New Delhi 110029

New Delhi
DELHI
110029
India 
Phone  9999501928  
Fax    
Email  amitchirom@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Rosy Saikia 
Designation  Senior Resident 
Affiliation  All India Institute Of Medical Sciences 
Address  All India Institutes of Medical Sciences, New Delhi
Department of Otorhinolaryngology and head and neck surgery
New Delhi
DELHI
110029
India 
Phone  9508679525  
Fax    
Email  rosysaikia.2822@gmail.com  
 
Source of Monetary or Material Support  
na 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences 
Address  Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi-110029 
Type of Sponsor  Government medical college 
 
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 Rosy Saikia  All India Institute of Medical Sciences  Department of Otorhinolaryngology and head and neck surgery All India Institutes of Medical Sciences, New Delhi 110029
New Delhi
DELHI 
9508679525

rosysaikia.2822@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute ethics commitee, AIIMS, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C068||Malignant neoplasm of overlappingsites of other and unspecified parts of mouth,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nil  nil 
 
Inclusion Criteria  
Age From  0.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Histologically proven Squamous Cell Carcinoma
Site Oral Cavity
Subsites Lip tongue the floor of the mouth buccal mucosa hard palate retromolar trigone gingivo alveolar complex
Stage I IV M0 according to AJCC 8th edition
Treated primarily by adequate surgery at AIIMS or NCI from January 2022 till the date of thesis submission
All patients who have a follow up of at least 6 months from the date of the last adjuvant therapy
Patients with ECOG Performance Status 0 to 2  
 
ExclusionCriteria 
Details  Non-squamous histology
Any distant metastasis
History of any previous malignancy in the past 5 years
Patient ASA more than 2
History of any therapeutic irradiation to the head and neck region
Patients with Poor Performance Status of 3 or more 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Morbidity which may be surgical Surgical Site Infection Wound Dehiscence
Hematoma Salivary Leak Chyle Leak Flap Necrosis or medical conditions which
may prolong hospital stay or lead to readmissions 
30 days after post surgery 
 
Secondary Outcome  
Outcome  TimePoints 
to assess overall survival, disease free survival,sii, h-index,nlr,obesity, radiation toxicity  upto 2 years post surgery 
 
Target Sample Size   Total Sample Size="299"
Sample Size from India="299" 
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)   03/03/2025 
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   Oral Squamous Cell Carcinoma has a very high incidence in India. Despite major advances in the treatment modalities over the past few decades, the overall survival rates have not changed dramatically. Although there aren’t many modifiable risk factors before treatment, sarcopenia has the potential to be a predictive and prognostic factor for patients with head and neck cancer . Identifying patients who may not respond well to their treatment could aid in its modification and guide further research in these higher-risk populations. This study aims to examine the impact of sarcopenia on postoperative outcomes, its association with obesity and blood parameters, and its influence on radiation-induced toxicity and quality of life in patients who have undergone surgery with or without PORT. As sarcopenia involves both muscle mass and function loss, it is essential to evaluate these parameters comprehensively—an area less extensively studied in head and neck cancer patients. Given that sarcopenia’s cutoff values differ by geographic region, race, sex, and age, establishing reference values specific to this region is crucial.
An ambispective analysis will be conducted at a tertiary cancer care centre over a period of 2 years. All patients with oral cancer who have been treated or planned to be treated primarily by surgery and are satisfying the inclusion and exclusion criteria will be included in the study. The patient details, height, weight, BMI, blood parameters, HPE , clinical - radiological reports will be retrieved from the medical records department to ascertain eligibility and the pre-operative CT scans will be retrieved from the department of radiology,for the retrospective group of patients. For the prospective group patient, patient details , height, weight, BMI, will be taken preoper preopratively within 3 months of surgery. Preoperative scans will be done . Muscle function will be assessed preoperatively by hand grip test, chair test, gait test. The date and type of surgery will be recorded. The postoperative period will be reviewed with the records and with the patients for any complications. The patients in the retrospective group will be called to follow up whereas the patients in the prospective group will be followed up as per NCCN follow-up protocol. They will be followed up every month for the first year and every 2nd month for the second year. Thereafter, follow-up will be scheduled every 6 months till the 5th year and once a year after that. The Quality of Life (QoL) will be assessed using previously validated questionnaires (SARC-F). The patient who has received PORT will be assessed for short-term and long-term radiation toxicity using Common Terminology Criteria for Adverse Events (CTCAE) v4.0 and criteria of Radiation Therapy Oncology Group (RTOG).
 
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