| CTRI Number |
CTRI/2024/07/071736 [Registered on: 31/07/2024] Trial Registered Prospectively |
| Last Modified On: |
31/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Radiation Therapy |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Acute reactions and dosimetry associated with old and new adjuvant radiation in carcinoma breast |
|
Scientific Title of Study
|
Acute toxicities and dosimetry associated with conventional and hypo fractionated adjuvant radiation in carcinoma breast. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
YENEPOYA UNIVERSITY MEDICAL COLLEGE HOSPITAL |
| Designation |
MD Resident Radiation Oncology |
| Affiliation |
DEEMED TO BE UNIVERSITY NABH ACCREDITATED |
| Address |
UNIVERSITY ROAD DERALAKATTE ULLAL MANGALORE KARNATAKA 575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8548845528 |
| Fax |
|
| Email |
sharikrishnanair@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suryanarayana Kunikullaya |
| Designation |
Professor |
| Affiliation |
Yenepoya University Medical College Hospital |
| Address |
ZULEKKHA YENEPOYA INSTITUTE OF ONCOLOGY
UNIVERSITY ROAD DERALAKATTE ULLAL MANGALOREKARNATAKA 575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9427357641 |
| Fax |
|
| Email |
skunikullaya@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suryanarayana Kunikullaya |
| Designation |
Professor |
| Affiliation |
Yenepoya University Medical College Hospital |
| Address |
ZULEKKHA YENEPOYA INSTITUTE OF ONCOLOGY
UNIVERSITY ROAD DERALAKATTE ULLAL MANGALORE KARNATAKA 575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9427357641 |
| Fax |
|
| Email |
skunikullaya@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Yenepoya Medical College Hospital Yenepoya Deemed To Be University
University road Deralakatte Ullal Karnataka 575018
|
|
|
Primary Sponsor
|
| Name |
Dr.Harikrishna Suresh |
| Address |
Yenepoya medical college, University Road, Deralakatte, Ullal, KArnataka 575018 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Yenepoya University Medical College Hospital |
University Road, Deralakatte, Ullal, Karnataka 575018 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Harikrishna Suresh |
Yenepoya Medical College Hospital |
University Road Deralakatte Mangaluru
ROOM NO 4 ZULEKHA YENEPOYA INSTITUTE OF ONCOLOGY RADIATION ONCO OPD
RADIATION ONCOLOGY DEPARTMENT LB
Dakshina Kannada
KARNATAKA |
8548845528
sharikrishnanair@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: C509||Malignant neoplasm of breast of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ACUTE EFFECTS OF ADJUVANT RADIOTHERAPY IN CONVENTIONAL AND HYPO-FRACTIONATED REGIMENS IN CARCINOMA BREAST |
COMPARING THE RADIATION EFFECCTS IN BOTH THE REGIMENS.
ONE IS CONVENTIONAL 50 gY IN 25 FRACTIONS AND OTHER ONE IS HYPOFRACTIONATED 40 Gy IN 15 FRACTIONS
|
| Comparator Agent |
RADIATION THERAPY
50 Gy in 25 fractions |
50 Gy in 25 fractrions,
Radiation is given as an adjuvant modality of treatmentin ca breas the conventional radiation dose is 50 Gy which is given in 25 fractions and the new regimen START protocol the dose is 40 Gy in 25 fractiosns so comparing the acute reactions in both the regimens |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are above the age of 18 years diagnosed with early stage or locally advanced carcinoma breast, has undergone mastectomy or breast conservative surgery who will be required to undergo adjuvant radiotherapy. |
|
| ExclusionCriteria |
| Details |
PATIENTS WITH METASTATIC DISEASE
PATIENTS WITH RELAPSE
MENTALLY CHALLENGED PATIENTS |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the acute reactions IN both conventional and hypo fractionated regimens.
|
BEFORE THE STARTING OF THE TREATMENT 0 WEEK
DURING THE TREATMENT 4 TH WEEK
POST TREATMENT 2 MONTH 6 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the quality of life |
At the end of the treatment
At 3 MONTHS AND 6 MONTHS AFTER COMPLETION OF THE TREATMENT |
|
|
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)
|
12/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
12/08/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The study aims to evaluate the acute reactions and dosimetry in conventional fractionationated radiotherapy compared to hypofractionated radiotherapy in breast cancer patients. It also aims to assess the doses to the organs at risk. The research question or hypothesis is that hypo - fraction radiotherapy is comparable to convntional fractionation radiotherapy in terms of acute adverse effects and dosimetric parameters.Aditionally hypo-fractionated radiotherapyis expected to improve patient compliance. |