| CTRI Number |
CTRI/2025/11/097104 [Registered on: 07/11/2025] Trial Registered Prospectively |
| Last Modified On: |
24/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of respiratory and functional performance in breast cancer patients receiving chemotherapy |
|
Scientific Title of Study
|
Assessment of respiratory muscle strength and functional capacity in breast cancer patients on chemotherapy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MSRMC/EC/PG-64/07-2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Yajna J Amin |
| Designation |
Post graduate student |
| Affiliation |
M S Ramaiah college of physiotherapy |
| Address |
M S Ramaiah college of Physiotherapy, Ramaiah university of applied sciences , MSR nagar , Bangalore 560054
M S Ramaiah college of Physiotherapy, Ramaiah university of applied sciences , MSR nagar , Bangalore 560054
Bangalore
KARNATAKA
-560054
India |
| Phone |
8310412081 |
| Fax |
|
| Email |
yajnajamin@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Yajna J Amin |
| Designation |
Post graduate student |
| Affiliation |
M S Ramaiah college of physiotherapy |
| Address |
M S Ramaiah college of Physiotherapy, Ramaiah university of applied sciences , MSR nagar , Bangalore 560054
M S Ramaiah college of Physiotherapy, Ramaiah university of applied sciences , MSR nagar , Bangalore 560054
Bangalore
KARNATAKA
-560054
India |
| Phone |
8310412081 |
| Fax |
|
| Email |
yajnajamin@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Yajna J Amin |
| Designation |
Post graduate student |
| Affiliation |
M S Ramaiah college of physiotherapy |
| Address |
M S Ramaiah college of Physiotherapy, Ramaiah university of applied sciences , MSR nagar , Bangalore 560054
M S Ramaiah college of Physiotherapy, Ramaiah university of applied sciences , MSR nagar , Bangalore 560054
Bangalore
KARNATAKA
-560054
India |
| Phone |
8310412081 |
| Fax |
|
| Email |
yajnajamin@gmail.com |
|
|
Source of Monetary or Material Support
|
| M S Ramaiah College of Physiotherapy , Bangalore - 560054 |
|
|
Primary Sponsor
|
| Name |
Yajna J Amin |
| Address |
M S Ramaiah Medical college, Triveni ladies hostel room no 516, M S R Nagar , Bangalore |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Chaitali Kadam PT |
Ramaiah Medical College and Hospital |
M S Ramaiah college of Physiotherapy, Ramaiah university of applied sciences , MSR nagar , Bangalore 560054
Bangalore
KARNATAKA |
9768430163
chaitalikadam1210@gmail.com |
| Dr Veena Kiran Nambiar PT |
M S Ramaiah Memorial Hospital, Bangalore |
M S Ramaiah Hospital, MSR Nagar, Bangalore - 560054
Bangalore
KARNATAKA |
9880575407
veenakn.rcp@msruas.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| M S Ramaiah Medical College and Hospital |
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, (2) ICD-10 Condition: C50-C50||Malignant neoplasms of breast, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
• Females diagnosed with Breast Cancer stages one,two,three
• Patients on chemotherapy.
|
|
| ExclusionCriteria |
| Details |
neurological conditions
musculoskeletal conditions |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Respiratory Muscle strength : Maximal inspiratory pressure (MIP)
Functional capacity : Six-minute walk distance
|
baseline
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 6 minute walk test |
baseline |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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)
|
14/11/2025 |
| 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
|
After obtaining ethical clearance from the Ramaiah Medical College Ethics Committee. 54 individuals diagnosed with Breast cancer disease by a surgical oncology consultant will be recruited based on inclusion and exclusion criteria. The individuals will be explained the need of the study, and participation information and consent will be obtained. Respiratory muscle strength and functional capacity will be assessed by Maximal inspiratory pressure (MIP) and Six-minute Walk distance (6MWD), respectively. |