| CTRI Number |
CTRI/2020/05/025121 [Registered on: 12/05/2020] Trial Registered Prospectively |
| Last Modified On: |
10/05/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Measuring the changes in blood flow using Doppler Ultrasonography in patients undergoing chemotherapy |
|
Scientific Title of Study
|
Analysis of blood flow changes using Doppler Ultrasonography in patients receiving chemotherapy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Divya R |
| Designation |
Post Graduate |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Faculty of Physiotherapy
SRIHER (DU)
No. 1, Sri Ramachandra Nagar
Porur
Chennai
TAMIL NADU
600116
India |
| Phone |
9600169985 |
| Fax |
|
| Email |
divya17rajamuthu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
T Senthil Kumar |
| Designation |
Associate Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Faculty of Physiotherapy
SRIHER (DU)
No. 1, Sri Ramachandra Nagar
Porur
Chennai
TAMIL NADU
600116
India |
| Phone |
9444368189 |
| Fax |
|
| Email |
physiotsk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
T Senthil Kumar |
| Designation |
Associate Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Faculty of Physiotherapy
SRIHER (DU)
No. 1, Sri Ramachandra Nagar
Porur
Chennai
TAMIL NADU
600116
India |
| Phone |
9444368189 |
| Fax |
|
| Email |
physiotsk@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai |
|
|
Primary Sponsor
|
| Name |
Divya R |
| Address |
Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai |
| Type of Sponsor |
Other [Self funded project] |
|
|
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 |
| Divya R |
Faculty of Physiotherapy |
Sri Ramachandra Institute of Higher Education and Research, No.1, Ramachandra nagar, Porur, Chennai-600116
Chennai
TAMIL NADU |
9600169985
divya17rajamuthu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D098||Carcinoma in situ of other specified sites, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients receiving single day and three day chemotherapy/cycle
2. Palliative and adjuvant chemotherapy
3. Population undergoing first and second cycle of chemotherapy |
|
| ExclusionCriteria |
| Details |
1. Patients with neuromuscular disorders
2. Patients with hand deformities, h/o fractures and implants
3. Patients with long term history of diabetes |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Doppler Ultrasonography |
Baseline - 1st day of first cycle chemotherapy
Post - 1st day of second cycle of chemotherapy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hand grip strength |
Baseline - 1st day of first cycle of chemotherapy
Post - 1st day of second cycle of chemotherapy |
|
|
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)
|
15/05/2020 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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)?
|
|
Brief Summary
|
It is an observational study, which will be conducted at Physical Rehabilitation Centre, Faculty of Physiotherapy, Sri Ramachandra Institue of Higher Education and Research. This study involves in the analysis of blood flow changes by means of Doppler Ultrasonography in patients undergoing 1st and 2nd cycle of chemotherapy, and also their handgrip strength will be assessed before and after chemotherapy. Patients receiving both palliative and adjuvant chemotherapy within the age limit of 35years and 55years are included. Patients with neuromuscular and orthopaedic conditions are excluded. Their baseline measurements of blood flow parameters and handgrip strength will be measured before and after chemotherapy. The collected data will be further evaluated and analyzed. |