| 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
|
|
|
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
|
|
|
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
|
|
|
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). |