| CTRI Number |
CTRI/2023/08/056411 [Registered on: 11/08/2023] Trial Registered Prospectively |
| Last Modified On: |
10/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To Study The Predictors of Lymphedema in Ipsilateral Arm in Patients treated with Modified Radical Mastectomy for Breast Cancer
|
|
Scientific Title of Study
|
To Study The Predictors of Lymphedema in Ipsilateral Arm in Patients treated with Modified Radical Mastectomy for Breast Cancer
-A Prospective observational study
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MOHD OZAIR KHAN |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
AIIMS RISHIKESH |
| Address |
Department of General Surgery, AIIMS Rishikesh, Virbhadra Marg, Rishikesh , India
Dehradun
UTTARANCHAL
249203
India |
| Phone |
7017662384 |
| Fax |
|
| Email |
ozairkhan321@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Farhanul Huda |
| Designation |
Additional Professor |
| Affiliation |
AIIMS RISHIKESH |
| Address |
DEPARTMENT OF GENERAL SURGERY, AIIMS RISHIKESH, VIRBHADRA MARG, RISHIKESH, INDIA
UTTARANCHAL
249203
India |
| Phone |
9997533211 |
| Fax |
|
| Email |
farhanul1973huda@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
MOHD OZAIR KHAN |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
AIIMS RISHIKESH |
| Address |
DEPARTMENT OF GENERAL SURGERY, AIIMS RISHIKESH, VIRBHADRA MARG, RISHIKESH, INDIA
UTTARANCHAL
249203
India |
| Phone |
7017662384 |
| Fax |
|
| Email |
ozairkhan321@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of general surgery, AIIMS rishikesh , for infrastructural support |
|
|
Primary Sponsor
|
| Name |
AIIMS RISHIKESH |
| Address |
DEPARTMENT OF GENERAL SURGERY, AIIMS RISHIKESH, VIRBHADRA MARG, RISHIKESH, INDIA |
| Type of Sponsor |
Government medical college |
|
|
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 MOHD OZAIR KHAN |
AIIMS RISHIKESH |
Department of General Surgery, In patient department ward 353 and 354 And OPD, second floor, AIIMS Rishikesh, VIRBHADRA MARG, RISHIKESH 249203
Dehradun
UTTARANCHAL |
07017662384
ozairkhan321@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS RISHIKESH |
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 |
| Comparator Agent |
NIL |
NIL |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Female |
| Details |
1.All Female Patients >18 years of age with Biopsy proven Infiltrating Ductal Carcinoma (Adenocarcinoma) Breast
cancer who underwent Modified Radical Mastectomy
2.Giving Informed consent for being included in the study
|
|
| ExclusionCriteria |
| Details |
Preexisting Lymphedema of the Ipsilateral arm.
Axillary Vein thrombosis
Metastatic Breast cancer
Bilateral breast cancer
Recurrent breast cancer
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the Patient factors & Tumour factors as Predictors of Arm Lymphedema in breast cancer patients undergoing Modified Radical Mastectomy
|
To study the Patient factors & Tumour factors as Predictors of Arm Lymphedema in breast cancer patients undergoing Modified Radical Mastectomy
Lymphedema/arm size will be recorded at baseline 1 month, 3 months and 6 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To find the Prevalence of Arm Lymphedema in patients who have undergone Modified Radical Mastectomy.
|
at end of study, 18 months |
Compare prevalence of Arm Lymphedema in patients who have undergone Modified Radical Mastectomy among different stages of Breast cancer.
|
at end of study, 18 months |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
18/08/2023 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
•Sample
size: All Breast cancer patients presenting to OPD during the study duration.
•Sample
size calculation was done By Fleiss formula with continuity correction and
minimum sample size was calculated to be 150
•Study
Duration : 18 months
•Study
Design : Prospective Observational study
•Data
Collection Methods : A structured proforma will be made and demographic and
clinical data will be collected at pre defined intervals: 0, 1 and 6 months
•Definition
of lymphedema :Post-surgical Arm lymphedema represents the increase of the arm
volume over 10% which occurs in the first 3 months after
surgical treatment. |