| CTRI Number |
CTRI/2026/01/101145 [Registered on: 14/01/2026] Trial Registered Prospectively |
| Last Modified On: |
06/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Education Program to Prevent Falls in Cancer Patients with chemotherapy related nerve problems and their caregivers. |
|
Scientific Title of Study
|
Development and Validation of an Educational material on Fall Risk for Patients with Chemotherapy-Induced Peripheral Neuropathy and Their Caregivers. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chandhiraleka |
| Designation |
Post graduate |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research. |
| Address |
No.1,Ramachandra Nagar, Porur, Chennai - 600 116, Tamil Nadu,India.
Chennai
TAMIL NADU
600116
India |
| Phone |
9841983170 |
| Fax |
|
| Email |
chandiralekha83@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
K Ramalakshmi |
| Designation |
Lecturer |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
No.1,Ramachandra Nagar, Porur, Chennai - 600 116, Tamil Nadu,India.
Chennai
TAMIL NADU
600116
India |
| Phone |
7708680087 |
| Fax |
|
| Email |
ramalakshmi22@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
K Ramalakshmi |
| Designation |
Lecturer |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
No.1,Ramachandra Nagar, Porur, Chennai - 600 116, Tamil Nadu,India.
Chennai
TAMIL NADU
600116
India |
| Phone |
7708680087 |
| Fax |
|
| Email |
ramalakshmi22@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
S Chandhiraleka |
| Address |
No. 1, Ramachandra Nagar, Porur, Chennai - 600 116, Tamil Nadu, India. |
| Type of Sponsor |
Other [self sponcer] |
|
|
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 Chandhiraleka S |
Sri Ramchandra Hospital |
No.1,Ramachandra Nagar, Porur, Chennai - 600 116, Tamil Nadu,India.
Chennai
TAMIL NADU |
9841983170
chandiralekha83@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee For Students Project |
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 |
| Intervention |
Nil |
Nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
64.00 Year(s) |
| Gender |
Both |
| Details |
Both gender, aged above 18 -64 years
Gynaecological and gastrointestinal cancer
|
|
| ExclusionCriteria |
| Details |
1. Patients who are already diagnosed with Peripheral Neuropathy.
2. Patients who are unable to do functional activity will be excluded.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Im not using any outcomes for my study as it is a development educational material validation with experts opinion. |
nil |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
20/01/2026 |
| 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 Yet Recruiting |
| 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
|
MethodologyProcedure To Be Followed: Step 1: to develop an educational material Step 2:To validate with experts opinion (2-3) Step 3:To do correction based on experts opinion Step 4: validation of the Education material Step 5:. To identify and recruit 20-30 cancer subjects undergoing chemotherapy with symptoms of chemotherapy induced peripheral neuropathy with risk of fall Step 2: Ensure the subjects meet inclusion criteria (both gender, aged above 18-64 years). Step 5: To validate (with experts) · The study mainly focuses on development of an educational material. · The educational material will be validated with experts opinion and changes will be made based on the opinions received during the process of the study. · The educational material will be given to patient only to analyze whether they are able to understand or not understand the content of the material. · Any queries about the educational material content will be duly addressed with expert validation.
|