| CTRI Number |
CTRI/2024/11/076905 [Registered on: 18/11/2024] Trial Registered Prospectively |
| Last Modified On: |
15/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study on Patient-Reported Outcomes for Acute Toxicity in Breast Cancer Patients Undergoing Radiation Therapy and Its Impact on Quality of Life |
|
Scientific Title of Study
|
A Prospective Study On Patient Reported Outcomes For Acute Toxicity In Breast Cancer Patients Receiving Radiation Therapy And Its Impact On Quality Of Life |
| 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 Lucky Kumawat |
| Designation |
DNB Junior Resident Radiation Oncology |
| Affiliation |
|
| Address |
Max Super Specialty Hospital
W-3, Sector-1, Vaishali, Ghaziabad- 201012. U.P.
Ghaziabad UTTAR PRADESH 201012 India |
| Phone |
8200761884 |
| Fax |
|
| Email |
luckykumawat44@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Rashi Agrawal |
| Designation |
Associate Director Radiation Oncology |
| Affiliation |
|
| Address |
Max Super Specialty Hospital
W-3, Sector-1, Vaishali, Ghaziabad- 201012. U.P.
Ghaziabad UTTAR PRADESH 201012 India |
| Phone |
9891483550 |
| Fax |
|
| Email |
drrashi.ag@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Rashi Agrawal |
| Designation |
Associate Director Radiation Oncology |
| Affiliation |
|
| Address |
Max Super Specialty Hospital
W-3, Sector-1, Vaishali, Ghaziabad- 201012. U.P.
Ghaziabad UTTAR PRADESH 201012 India |
| Phone |
9891483550 |
| Fax |
|
| Email |
drrashi.ag@gmail.com |
|
|
Source of Monetary or Material Support
|
| Max Super Specialty Hospital
W-3, Sector-1, Vaishali, Ghaziabad- 201012. U.P. |
|
|
Primary Sponsor
|
| Name |
Dr Lucky Kumawat |
| Address |
Max Super Specialty Hospital
W-3, Sector-1, Vaishali, Ghaziabad- 201012. U.P. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Lucky Kumawat |
Max Super Specialty Hospital W-3, Sector-1, Vaishali, Ghaziabad- 201012. U.P. |
Department of Radiation Oncology , Tower 1 lower basement
Ghaziabad UTTAR PRADESH |
8200761884
luckykumawat44@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C50-C50||Malignant neoplasms of breast, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
Age 18 years
Female patients
Biopsy proven invasive breast cancer
Post operative breast cancer patients having standard indication of radiation therapy
Non metastatic |
|
| ExclusionCriteria |
| Details |
Recurrence of disease in ipsilateral or contralateral side
Patients who have previously received radiation therapy to chest |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Base don the findings there might be recommendations for adjusting radiation therapy parameters to improve the balance between treatment efficacy and quality of life preservation |
At start of the treatment , at the completion of treatment, 3 months after completion of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The results will be reviewed via EORTC QLQ-C30, BR23 questionnaire at start of the treatment , at the completion of treatment, 3 months after completion of treatment |
At start of the treatment , at the completion of treatment, 3 months after completion of 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)
|
26/11/2024 |
| 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) |
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
|
Breast cancer is the most commonly diagnosed malignancy
and the leading cause of death among women worldwide. Breast cancer alone is responsible for 30% (1) of newly diagnosed cancer cases in women and
there is a probability that one in eight women
will develop breast cancer in her lifetime, while 14% of cancer-related
deaths are attributed to it. More
than 100,000 patients are estimated to be diagnosed with breast cancer every year in India which depicts
the disease burden. Breast cancer has been
rising steadily over the last decade or so, and is now the most common
cancer in women in India, way ahead of cervical cancer (which was the leading
cancer previously). Breast cancer treatment
is highly effective, especially when the disease is identified in early stage.
Treatment of breast
cancer often consists
of a combination of surgery, radiation therapy and systemic
therapy (hormonal therapy, chemotherapy and/or
targeted biological therapy). This multi-modality treatment of breast cancer is also associated with certain acute and
late adverse events affecting the quality of life of the patient.Hence, I am conducting present
study to determine the Patient Reported
Outcomes of acute
toxicities and its overall affect
on quality of life in this group of patients. |