| CTRI Number |
CTRI/2024/06/069291 [Registered on: 20/06/2024] Trial Registered Prospectively |
| Last Modified On: |
15/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of swallowing exercises and nutritional intervention in head and neck cancer patients |
|
Scientific Title of Study
|
A randomized clinical trial to assess the effectiveness of post operative swallowing exercises and nutritional intervention in patients undergoing Head and Neck Cancer treatment at a tertiary care center |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrDoppalapudi Radhika |
| Designation |
PhD Scholar |
| Affiliation |
Saveetha Dental College, SIMATS |
| Address |
Department of Oral Medicine and Radiology, Saveetha Dental College, SIMATS, Chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
9441749522 |
| Fax |
|
| Email |
162315025.sdc@saveetha.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrArvind |
| Designation |
Professor and Head |
| Affiliation |
Saveetha Dental College, SIMATS |
| Address |
Department of Oral Medicine and Radiology and special care dentistry, Saveetha Dental College, Saveetha Institute of Medical and technical Sciences, Chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
9444303303 |
| Fax |
|
| Email |
arvindm@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
DrDoppalapudi Radhika |
| Designation |
PhD Scholar |
| Affiliation |
Saveetha Dental College, SIMATS |
| Address |
Department of Oral Medicine and Radiology, Saveetha Dental College, SIMATS, Chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
9441749522 |
| Fax |
|
| Email |
162315025.sdc@saveetha.com |
|
|
Source of Monetary or Material Support
|
| HCG Curie City Cancer Centre,
44-1-1/3, Padavalarevu,Gunadala, Vijayawada, Andhra Pradesh,India. PIN: 520004 |
|
|
Primary Sponsor
|
| Name |
Doppalapudi Radhika |
| Address |
Saveetha Dental College and Hospital, Saveetha Institute of Medical and Technical Sciences, Poonamallee high road, Vellapanchavadi, Chennai, Tamilnadu, India. PIN: 600077 |
| Type of Sponsor |
Other [self sponsor] |
|
|
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 Doppalapudi Radhika |
HCG Curie City Cancer Centre |
Ground floor,
Department of Radiology
Krishna
ANDHRA PRADESH |
9441749522
162315025.sdc@saveetha.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| HCG Curie City Cancer Centre |
Approved |
| SIMATS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C148||Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nutritional guidance |
Nutritional guidance by Nutritionist
Body mass index is recorded after 6months and 12 months |
| Intervention |
Swallowing exercises
|
Perform swallowing exercises as advised by the Physician
The improvement in mouth opening is recorded before and after performing swallowing exercises for a period of 6months and 12 months
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
head and neck cancer patients treated at a tertiary care center |
|
| ExclusionCriteria |
| Details |
patients who have undergone glossectomy as a part of the treatment for head and neck cancer
patients who are not willing to participate in the study |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in mouth opening
Body mass Index |
6 months
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of life assessment using EORCTC Head & Neck questionnaire |
6 months & 12 months |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
29/07/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
PhD THESIS with the title of A Randomized clinical trial to assess the effectiveness of swallowing exercises and nutritional intervention in patients undergoing head and neck cancer treatment at a tertiary care center Swallowing exercises are to be performed by the head and neck cancer patients as demonstrated and the improvement in mouth opening are noted. Nutritional health education is provided by the nutritionist and height, weight, body mass index before and after the treatment is noted. The EORCTC head and neck cancer questionnaire will be distributed to these patients and the responses on quality of life of these patients will be recorded. |