| CTRI Number |
CTRI/2024/03/063482 [Registered on: 04/03/2024] Trial Registered Prospectively |
| Last Modified On: |
29/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Functional Outcomes And Quality Of Life Of Operated Cases Of Carcinoma Tongue |
|
Scientific Title of Study
|
Functional Outcomes And Quality Of Life After Partial Glossectomy Done For Carcinoma Tongue: A Prospective Observational 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 |
Gautam Anand |
| Designation |
DrNB Resident |
| Affiliation |
Max Institute of Cancer Care |
| Address |
Room no 2614, Department Of Surgical Oncology Max Institute of Cancer Care
Vaishali
Ghaziabad
UTTAR PRADESH
201012
India |
| Phone |
9891182635 |
| Fax |
|
| Email |
gautam16alok@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pawan Gupta |
| Designation |
Director |
| Affiliation |
Max Institute of Cancer Care |
| Address |
Room No 2614, Department of Surgical Oncology, Max Institute Cancer Care
Vaishali
Ghaziabad
UTTAR PRADESH
201012
India |
| Phone |
9891182635 |
| Fax |
|
| Email |
drpawan.oncosurgeon@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gautam Anand |
| Designation |
DrNB Resident |
| Affiliation |
Max Institute of Cancer Care |
| Address |
Room no 2614, Department of Surgical Oncology Max Institute of Cancer Care
Vaishali
Ghaziabad
UTTAR PRADESH
201012
India |
| Phone |
9891182635 |
| Fax |
|
| Email |
gautam16alok@gmail.com |
|
|
Source of Monetary or Material Support
|
| Max Institute of Cancer Care, Vaishali |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
NA |
| Type of Sponsor |
Other [] |
|
|
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 Gautam Anand |
Max Institute of Cancer Care |
Room No 2614, Department of Surgical Oncology, Max Institute of Cancer Care, Vaishali, ghaziabad
Ghaziabad
UTTAR PRADESH |
9891182635
gautam16alok@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, Max Superspeciality Hospital, Vaishali |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C029||Malignant neoplasm of tongue, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
all pT1-T3 squamous cell carcinoma of the lateral aspect of tongue
All the patients who are planned for partial glossectomy and ipsilateral selective neck dissection.
|
|
| ExclusionCriteria |
| Details |
1.Surgery for relapse or head and neck second tumor
2.Involvement of median tongue line
3.Laryngeal, esophageal or neurological disorders that alter swallowing or phonation
4.Previous head and neck radiation therapy or neoadjuvant chemotherapy
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Quality of life as per EORTC QLQ-F17 and H & N 35 index |
6-12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
i. Functional outcomes as per SHI for speech intelligibility and speech articulation.
ii.Assessment of dysphagia as per EAT 10 score.
iii.Tongue motility assessment.
|
6-12months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
15/03/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
The
proposed study will be conducted at Max Superspeciality Hospital, Vaishali, Ghaziabad.
Objective of this study is to evaluate the long term functional outcomes and
quality of life after partial glossectomy done for carcinoma tongue. It is a
prospective study in which patients with carcinoma of the lateral aspect of
tongue requiring surgery not greater than hemi glossectomy will be included.
Intraoperative assessment will be done and the patient will undergo surgery.
The histopathology report of the patient will be collected. The patient with pT1-T3
lesion who underwent partial glossectomy will be selected for our study. The
patient will undergo speech therapy and swallowing therapy in the post
operative period. The patient requiring radiation therapy will undergo
radiation therapy as per the standard protocol of treatment. The patient will
be assessed 6 months after the surgery for the quality of life and functional
outcomes of the surgery with appropriate questionnaire and clinical examination.
Appropriate statistical analysis will be carried out at the end of study period.
|