| CTRI Number |
CTRI/2024/05/067205 [Registered on: 10/05/2024] Trial Registered Prospectively |
| Last Modified On: |
09/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Radiation Therapy |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Assessing the function of swallowing structures in delivering higher dose per fractions RT in locally advanced head and neck cancer. |
|
Scientific Title of Study
|
A study to assess the Radiation dose to Dysphagia/Aspiration at Risk Structures(DARS) and its impact on quality of life in patients receiving hypo-fractionated RT in locally advanced Head and Neck Squamous cell Carcinoma (LA-HNSCC) |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bilita Kumari Parhi |
| Designation |
Post Graduation |
| Affiliation |
yenepoya medical college |
| Address |
CAMPUS ID 32290
DEPARTMENT RADIATION ONCOLOGY
YENEPOYA MEDICAL COLLEGE
UNIVERSITY ROAD DERALKATE MANGALURU
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8895892952 |
| Fax |
|
| Email |
bilita07@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dinesh Makuny |
| Designation |
Professor and Head Of Department |
| Affiliation |
Yenepoya medical college |
| Address |
DEPARTMENT RADIATION ONCOLOGY
YENEPOYA MEDICAL COLLEGE
UNIVERSITY ROAD
DERALKATE MANGALURU
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8891717361 |
| Fax |
|
| Email |
dineshm@yenepoya.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dinesh Makuny |
| Designation |
Professor and Head Of Department |
| Affiliation |
Yenepoya medical college |
| Address |
DEPARTMENT RADIATION ONCOLOGY
YENEPOYA MEDICAL COLLEGE
UNIVERSITY ROAD
DERALKATE MANGALURU
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8891717361 |
| Fax |
|
| Email |
dineshm@yenepoya.edu.in |
|
|
Source of Monetary or Material Support
|
| Yenepoya Medical College Hospital,
University road,
Deralakatte,
Mangaluru,
India.
Pin-575018 |
|
|
Primary Sponsor
|
| Name |
Dr Bilita Kumari Parhi |
| Address |
Yenepoya Medical College Hospital,
University road,
Deralakatte,
Mangaluru,
India.
Pin-575018 |
| Type of Sponsor |
Other [Self] |
|
|
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 Bilita Kumari Parhi |
Yenepoya Medical College Hospital |
Department of Radiation Oncology,
University road,
Deralakatte,
Mangaluru,
India.
Pin-575018
Dakshina Kannada
KARNATAKA |
8895692952
bilita07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yenepoya Ethics Committee-1 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C01||Malignant neoplasm of base of tongue, (2) ICD-10 Condition: C050||Malignant neoplasm of hard palate, (3) ICD-10 Condition: C139||Malignant neoplasm of hypopharynx,unspecified, (4) ICD-10 Condition: C329||Malignant neoplasm of larynx, unspecified, (5) ICD-10 Condition: C109||Malignant neoplasm of oropharynx,unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
hypofractionated RT |
Hypofractionated external RT of 55Gy in 20 fractions for a total duration of 4weeks (5 days in a week).
Each day 2.75Gy will be delivered . |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1.Participants above 18 years of age diagnosed with head and neck cancer.
2.ECOG(Eastern Cooperative Oncology Group)status 0 or 1 will be taken.
3.Adult patients admitted with locally advanced biopsy-confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, larynx (stage II–IVA).
|
|
| ExclusionCriteria |
| Details |
1.Patients with tumors involving the thyroid, nasal cavity, nasopharynx and paranasal sinus are
not eligible as confirmed by CECT /MRI / PET- CT findings and biopsy findings.
2.Patients with distant metastasis.
3.Patients who have received radiotherapy previously
4.Relapse/recurrence
5.Pregnant women.
6.Tracheostomized patient.
7.Body weight less than 30 kgs.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sparing of dysphagia aspiration associated risk structure,improved swallowing during and post treatment. |
assessment shall be done on day of admission,3months,6months,1yr post completion of RT. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hypofractionated schedule for treatment of head and neck cancer. |
18 months |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
20/05/2024 |
| 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="0"
Months="11"
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
|
DARS structures (dysphagia and aspiration at risk) are the muscles which are directly
involved in the act of swallowing,they are the pharyngeal
constrictors(superior,middle,inferior)along with base of tongue muscle(cricopharyngeal)and
esophageal inlet muscles. DuringRT(radiation therapy) to head and neck cancer patients ,these
structures receive some amount of the dose throughout the treatment and hence the patient has
symptoms of swallowing difficulty along with speech problems during and after treatment.
Hence this study is going to elucidate the effectiveness of Hypo fractionated RT with respect to
DARS sparing effect on swallowing apparatus, dysphagia and quality of life of patients with
head and neck cancer. This study is going to be performed on 38patients with head and neck
Squamous cell carcinoma between the year 2024 – 2026 and will be conducted at Yenepoya
medical college and hospital with follow up for all patients during(weekly) and post treatment at
3months,6months and 12months respectively. |