| CTRI Number |
CTRI/2019/08/020977 [Registered on: 29/08/2019] Trial Registered Prospectively |
| Last Modified On: |
28/08/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study to translate self reported shoulder dysfunction after surgery in Head Neck cancer patients |
|
Scientific Title of Study
|
A Study to translate and validate self reported shoulder dysfunction scales into Hindi and Marathi in patients of Head and Neck cancers |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Version 2.1 dated 31.05.2019 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gouri Pantvaidya |
| Designation |
surgical Oncologist |
| Affiliation |
Tata Memorial Hospital |
| Address |
12th Floor, Room No. 1230, HBB Block Dr E Borges Road Parel Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9833971155 |
| Fax |
02224146392 |
| Email |
docgouri@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gouri Pantvaidya |
| Designation |
surgical Oncologist |
| Affiliation |
Tata Memorial Hospital |
| Address |
12th Floor, Room No. 1230, HBB Block Dr E Borges Road Parel Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9833971155 |
| Fax |
02224146392 |
| Email |
docgouri@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gouri Pantvaidya |
| Designation |
surgical Oncologist |
| Affiliation |
Tata Memorial Hospital |
| Address |
12th Floor, Room No. 1230, HBB Block Dr E Borges Road Parel Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9833971155 |
| Fax |
02224146392 |
| Email |
docgouri@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Memorial Hospital
Dr E borges Road Prel Mumbai 400012 |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
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 Gouri Pantvaidya |
Tata Memorial Hospital |
2nd Floor, Room No. 201, HBB Block Tata Memorial Hospital Parel, Mumbai
Mumbai
MAHARASHTRA |
9833971155
02224146392
docgouri@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee-i |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G89-G99||Other disorders of the nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NA |
NA |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of head neck cancer who have undergone some form of neck dissection
2. Loco-regionally controlled
3. Age 18-75 years
4. Literate patients – patients who have studied high school and can read, write and understand either Hindi or Marathi.
5. ECOG 0, 1, 2 performance status |
|
| ExclusionCriteria |
| Details |
1. Age < 18 years or >75 years
2. Illiterate patients
3. ECOG status >2
4. Patients undergoing only level VI neck dissection |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To translate shoulder dysfunction specific questionnaires namely Constant shoulder scale and Neck Dissection Impairment Index into Hindi and Marathi |
At the start of the study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To generate psychometric data regarding the questionnaires’ reliability and validity when used in the Indian population
2. To compare the ease of administration between the two questionnaires i.e. Constant Shoulder Scale and neck dissection Impairment Index. |
6months |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
09/09/2019 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Neck dissection plays an integral part in the surgical management of head and neck cancers. Although neck dissection techniques were described as early as the eighteenth century, a systematic approach to it was described by George Washington Crile in 1906.1 The technique of neck dissection has undergone major transformations over the years, from Radical neck dissection to a Selective neck dissection.2 Neck dissection is a time tested procedure, however it is still associated with significant complications. Injury to the spinal accessory nerve results in the Painful Shoulder Syndrome or the 11th Nerve Syndrome. 3 The incidence of painful shoulder syndrome varies between the various types of neck dissection. It is highest in radical neck dissection (79%) and modified radical neck dissection (65%). 4 A lower incidence of Shoulder dysfunction syndrome has been seen in selective neck dissection. 5 Shoulder dysfunction in Selective neck dissection is primarily due to handling of the spinal accessory and thermal injury due to electrocautery, some authors therefore avoid dissection of Level IIb nodes in clinically N0 neck.5 Various scales such as self-report Flexilevel scale of shoulderfunction, constant shoulder score etc., are used to assess shoulder dysfunction in the post-operative period. 6, 7 Electromyography(EMG) is an objective way to evaluate shoulder dysfunction, and it has been shown to be a sensitive and painless method.8 However EMG may not be available at all times and therefore there needs to be an alternative way to detect shoulder dysfunction. NDII and Constant Morley’s scales are widely used to subjectively assess degree of shoulder dysfunction. Constant’s score was devised by Christopher Constant for standardisation of shoulder function assessment, it was revised and modified in 2008. NDII was devised as a health-related quality-of-life (QOL) instrument for patients following neck dissection and to identify the factors that affect QOL following neck dissection in 2002 by Rodney Taylor, it is approved by the American association of Shoulder and elbow surgeons. In this study, we aim to translate the constant shoulder scale and NDII and validate these scales. Early confirmation of shoulder dysfunction would aid to initiate early physical therapy for the patients which would reduce the associated morbidity. |