| CTRI Number |
CTRI/2022/02/040699 [Registered on: 28/02/2022] Trial Registered Prospectively |
| Last Modified On: |
25/02/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Exploratory study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Finding the Minimal change in value of Six Minute Walk Distance in patients with Breast Cancer. |
|
Scientific Title of Study
|
Estimating the minimal clinically important
difference of the
six minutes walk distance in patients with breast cancer |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ravindra Reddy C |
| Designation |
Post graduate student- physiotherapy |
| Affiliation |
Kasturba medical college |
| Address |
Department of Physiotherapy, KMC hospital, Jyoti circle Mangalore
Dakshina Kannada
Dakshina Kannada
KARNATAKA
575003
India |
| Phone |
|
| Fax |
|
| Email |
raviramu30@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Stephen Rajan Samuel |
| Designation |
Asst. Professor-Senior Scale |
| Affiliation |
Kasturba medical college |
| Address |
Department of Kasturba Medical College, Mangalore
Dakshina Kannada
Dakshina Kannada
KARNATAKA
575003
India |
| Phone |
|
| Fax |
|
| Email |
stephen.samuel@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Ravindra Reddy C |
| Designation |
Post graduate student |
| Affiliation |
Kasturba medical college |
| Address |
Department of Physiotherapy, KMC hospital, Jyoti circle Mangalore
Dakshina Kannada
Dakshina Kannada
KARNATAKA
575003
India |
| Phone |
|
| Fax |
|
| Email |
raviramu30@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Manipal University |
| Address |
Light house ,Hill road Mangalore 575001 |
| Type of Sponsor |
Private 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 |
| ravindra reddy |
Kasturba Medical College |
6th floor, oncology ward
Dakshina Kannada
KARNATAKA |
9566726536
raviramu30@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Kasturba Medical College, Mangalor |
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
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Female |
| Details |
1. Patients with Breast Cancer stage II–III scheduled for curative intent chemotherapy treatment.
2. ECOG (Eastern Cooperative Oncology Group) performance status <2
3. Age 18years of age
|
|
| ExclusionCriteria |
| Details |
1. Any musculoskeletal problems (e.g. knee pain, ankle pain)
2. Comorbidities limiting the 6MWT field testing (eg: cardiac arrhythmias, acute myocardial infarction, angina pectoris, patients with LVEF < 40 %)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) To estimate the minimally clinical important difference (MCID) of six minute walk distance (6MWD) in patients with Breast Cancer using Anchor and Distribution based methods.
2) To evaluate the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) at baseline (pretreatment) and after 16 weeks and to correlate physical domain of the questionnaire with Six minute walk distance (6MWD).
|
Baseline and 16 weeks.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
01/03/2022 |
| 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="1"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study protocol will be submitted to the Scientific and Institutional Ethics Committee, KMC Mangalore and upon approval, patients diagnosed with Breast Cancer and scheduled for Chemotherapy would be screened for inclusion and exclusion criteria. Patients fulfilling the inclusion criteria would be explained about the study and the willing participants would be asked to sign a written consent. Demographic data of the participants will be collected and written by the investigator. Participants would undergo 6MWT at baseline (pretreatment) and after 16 weeks. The quality of life over the past week will be assessed by the EORTC QLQ-C30 at baseline and after 16 weeks and will be graded by the Likert scale. Based on the anchor (Using the physical domain changes in questionnaire) and distribution (standard error, effect size of 6MWD based methods, statistically using (Boot strap) the MCID of 6MWD in patients with Breast Cancer will be calculated. |