| CTRI Number |
CTRI/2025/02/081093 [Registered on: 21/02/2025] Trial Registered Prospectively |
| Last Modified On: |
24/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Study to understand how well can elderly patients withstand surgery for head and neck cancer |
|
Scientific Title of Study
|
Study to evaluate the short term outcomes of Comprehensive geriatric assessment in elderly patients undergoing surgical treatment of head and neck cancer |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Abhilash Konkimalla |
| Designation |
Assistant Professor |
| Affiliation |
Nizams Institute of Medical Sciences |
| Address |
Department of Surgical Oncology
4th floor, Specialty Block
NIMS, Panjagutta, Hyderabad
Hyderabad
TELANGANA
500082
India |
| Phone |
9013454569 |
| Fax |
|
| Email |
abhilashkonkimalla@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Abhilash Konkimalla |
| Designation |
Assistant Professor |
| Affiliation |
Nizams Institute of Medical Sciences |
| Address |
Department of Surgical Oncology
4th floor, Specialty Block
NIMS, Panjagutta, Hyderabad
Hyderabad
TELANGANA
500082
India |
| Phone |
9013454569 |
| Fax |
|
| Email |
abhilashkonkimalla@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Abhilash Konkimalla |
| Designation |
Assistant Professor |
| Affiliation |
Nizams Institute of Medical Sciences |
| Address |
Department of Surgical Oncology
4th floor, Specialty Block
NIMS, Panjagutta, Hyderabad
Hyderabad
TELANGANA
500082
India |
| Phone |
9013454569 |
| Fax |
|
| Email |
abhilashkonkimalla@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nizams Institute of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
NIMS |
| Address |
Department of Surgical Oncology, NIMS, Panjagutta, Hyderabad India- 500082 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Abhilash Konkimalla |
Nizams Institute of Medical Sciences |
Surgical Oncology Ward, Department of Surgical Oncology (Division of Head and Neck Surgery), 4th floor, Specialty Block, NIMS, Panjagutta, Hyderabad
Hyderabad
TELANGANA |
9013454569
abhilashkonkimalla@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NIMS Institutional Ethics Committee |
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, (2) ICD-10 Condition: C08||Malignant neoplasm of other and unspecified major salivary glands, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Age more than 60 years
2. Undergoing curative intent surgery of head and neck cancer |
|
| ExclusionCriteria |
| Details |
1. Not consenting for the study
2. Inability to perform TUG test ( 6 m walk test) or hand grip strength testing |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Duration of hospital stay
Calvin Dindo grade of complication |
At time of discharge (post surgery) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Duration of ICU Stay
Ventilator requirement
Duration of Nasogastric feeding
Flap viability |
Till 30 days post surgery |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/03/2025 |
| 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)
|
Open to Recruitment |
| 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
|
Geriatric patients have a decreased physiological reserve to withstand aggressive surgical treatment. Frailty is a state of vulnerability to poor homeostasis post a stressor event such as chemotherapy or surgery. Handforth et al in their systematic review calculated the prevalence of frail and pre frail patients to be in the range of 40 – 45%. Identification of frailty in geriatric oncology patients helps in predicting their response to treatment, ability to tolerate major ablative procedures, recovery post treatment and even overall survival. Elderly patients with good performance status have good outcomes to curative head and neck cancer patients, however they have longer hospital stays, tube dependence and non-fatal cardiac event. The rationale for the study is to identify at risk/ frail patients of head and neck cancer, predict and mitigate their complications and provide successful curative surgical intervention and post operative outcomes. |