| CTRI Number |
CTRI/2025/12/099480 [Registered on: 19/12/2025] Trial Registered Prospectively |
| Last Modified On: |
18/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
How Nerve Damage Affects Daily Life and Physical Abilities in Women with Non Metastatic Breast Cancer. |
|
Scientific Title of Study
|
Characteristics of peripheral neuropathy and its impact on quality of life, physical function in non-metastasis breast cancer patients. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Surya S |
| Designation |
Undergraduate Student |
| Affiliation |
Sri Ramachandra Institute Of Higher Education Research |
| Address |
35,Abith Nagar, Choolaimedu, Chennai
Faculty of Physiotherapy, Room NO 1.2, Floor 1, Sri Ramachandra Institute of Higher Education and Research[Deemed to be university],Porur, Chennai, Tamil Nadu , 600116, India
Chennai
TAMIL NADU
600094
India |
| Phone |
9710188044 |
| Fax |
|
| Email |
t0121098@sriher.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Surya S |
| Designation |
Undergraduate Student |
| Affiliation |
Sri Ramachandra Institute Of Higher Education Research |
| Address |
35,Abith Nagar, Choolaimedu, Chennai
Faculty of Physiotherapy, Room NO 1.2, Floor 1, Sri Ramachandra Institute of Higher Education and Research[Deemed to be university],Porur, Chennai, Tamil Nadu , 600116, India
Chennai
TAMIL NADU
600094
India |
| Phone |
9710188044 |
| Fax |
|
| Email |
t0121098@sriher.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Surya S |
| Designation |
Undergraduate Student |
| Affiliation |
Sri Ramachandra Institute Of Higher Education Research |
| Address |
35,Abith Nagar, Choolaimedu, Chennai
Faculty of Physiotherapy, Room NO 1.2, Floor 1, Sri Ramachandra Institute of Higher Education and Research[Deemed to be university],Porur, Chennai, Tamil Nadu , 600116, India
Chennai
TAMIL NADU
600094
India |
| Phone |
9710188044 |
| Fax |
|
| Email |
t0121098@sriher.edu.in |
|
|
Source of Monetary or Material Support
|
| Faculty of Physiotherapy, Sri Ramachandra Institute of Higher Education and Research[Deemed to be university],Porur, Chennai, Tamil Nadu , 600116, India |
|
|
Primary Sponsor
|
| Name |
Sri Ramachandra Institute Of Higher Education Research |
| Address |
Sri Ramachandra Nagar, Porur, Chennai, Tamilnadu, 600116 |
| Type of Sponsor |
Research institution |
|
|
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 |
| Surya |
Sri Ramachandra institute of higher education and research . |
Faculty of Physiotherapy, Room NO 1.2, Floor 1, Sri Ramachandra Institute of Higher Education and Research[Deemed to be university],Porur
Chennai
TAMIL NADU |
9710188044
t0121098@sriher.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee for Students Project, Faculty of Physiotherapy, Sri Ramachandra Institute of Higher Education and Research[Deemed to be university],Porur, Chennai, Tamil Nadu , 600116, India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G620||Drug-induced polyneuropathy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Male and female patients diagnosed with non-metastatic breast cancer.
Patients undergoing chemotherapy and/or radiotherapy more than 3cycles. |
|
| ExclusionCriteria |
| Details |
Use of assistive devices or walking aids, indicating reduced mobility.
Muscle power less than grade 2 (not able to move limb against gravity).
Pre-existing peripheral neuropathy from causes other than chemotherapy (e.g., diabetes, toxicity, infection).
Advanced musculoskeletal disorders such as severe osteoarthritis, rheumatoid arthritis, chronic low back pain, or fibromyalgia with marked functional limitation.
Severe cognitive or psychiatric impairment that may interfere with reliable reporting or test completion.
Other neurological disorders affecting gait or sensory function (e.g., stroke, Parkinson’s, multiple sclerosis). |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Severity of chemotherapy-induced peripheral neuropathy symptoms assessed using a validated clinical scale (EORTC QLQ-CIPN20) in non-metastatic breast cancer patients after at least three cycles of chemotherapy. |
Baseline, After 3 Cycles of Chemotherapy. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Peripheral neuropathy severity assessed using Revised Total Neuropathy Score (RTNS),Physical function assessed using Timed Up & Go (TUG) test, Vibration Perception threshold assessed using Biothesiometer. |
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)
|
29/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
29/12/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
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
|
This cross sectional observational study aims to evaluate the characteristics of chemotherapy induced peripheral neuropathy and its impact on quality of life and physical function in non metastatic breast cancer patients who have completed more than three cycles of chemotherapy (adriamycin, docetaxel, cyclophosphamide or combinations) regardless of surgery or radiotherapy status. Neuropathy symptoms will be assessed using the EORTC QLQ-CIPN20 questionnaire and the Revised Total Neuropathy Score (RTNS). Vibration perception threshold assessed using a biothesiometer. Physical function and fall risk will be measured by the Timed Up Go (TUG) test.These will be evaluated a single time when the participant joins the study. Data on chemotherapy details, surgery, and radiotherapy status will be documented. All assessments will be performed at baseline during study enrolment. Ethical approval has been obtained, and informed consent will be taken from all participants. |