| CTRI Number |
CTRI/2025/07/091429 [Registered on: 22/07/2025] Trial Registered Prospectively |
| Last Modified On: |
22/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of duloxetine in prevention of chemotherapy induced peripheral neuropathy |
|
Scientific Title of Study
|
Role of duloxetine in the prevention of chemotherapy induced peripheral neuropathy in patients recieving paclitaxel |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Navjot Kaur |
| Designation |
Medical oncology resident |
| Affiliation |
Stanley medical College and hospital |
| Address |
Stanley medical College and hospital
Chennai
Chennai
TAMIL NADU
600001
India |
| Phone |
08360803851 |
| Fax |
|
| Email |
drugadd2009@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr PN Sathiyamoorthy |
| Designation |
Associate Professor |
| Affiliation |
Stanley medical College and hospital |
| Address |
Stanley medical College and hospital
Chennai
Chennai
TAMIL NADU
600001
India |
| Phone |
9444221535 |
| Fax |
|
| Email |
Sathiyamoorthypn@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr PN Sathiyamoorthy |
| Designation |
Associate Professor |
| Affiliation |
Stanley medical College and hospital |
| Address |
Stanley medical College and hospital
Chennai
Chennai
TAMIL NADU
600001
India |
| Phone |
9444221535 |
| Fax |
|
| Email |
Sathiyamoorthypn@gmail.com |
|
|
Source of Monetary or Material Support
|
| Stanley medical College and hospital Chennai
Medical oncology department |
|
|
Primary Sponsor
|
| Name |
Stanley medical College and hospital |
| Address |
Stanley medical College and hospital chennai |
| Type of Sponsor |
Government 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 |
| Dr Navjot Kaur |
STANLEY MEDICAL COLLEGE AND HOSPITAL |
Department of Medical Oncology
Stanley Medical College and Hospital
Old Jail road washermanpet
Chennai
TAMIL NADU |
8360803851
drugadd2009@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Stanley 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: C569||Malignant neoplasm of unspecifiedovary, (3) ICD-10 Condition: C349||Malignant neoplasm of unspecifiedpart of bronchus or lung, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Paclitaxel containing regimen |
Comparator arm will recieve paclitaxel containing regimen only |
| Intervention |
Tablet duloxetine |
It is single arm study and I will give tablet duloxetine 30 mg of for first week then 60 mg of for 3 months to patients who are receiving paclitaxel from first cycle |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
All patients recieving paclitaxel with any Cancer diagnosis with any stage will and able to comply with all study requirements with signed and written consent |
|
| ExclusionCriteria |
| Details |
Concurrent disease that may lead to peripheral neuropathy like diabetes mellitus
rheumatologic disease
vitamin B12 deficiency
any allergy to duloxetine
patients receiving ccb alfa blocker with psychiatric disorders
any bleeding manifestations and pregnant and lactating women |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the effect of duloxetine in the prevention of chemotherapy induced peripheral neuropathy in patients receiving paclitaxel |
12 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare dose modification of paclitaxel due to peripheral neuropathy in each arm |
3 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
05/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
05/08/2025 |
| 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 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
|
To study the effect of duloxetine in the prevention of chemotherapy induced peripheral neuropathy in patients receiving paclitaxel To compare dose modification of paclitaxel due to peripheral neuropathy in each arm 20% dose reduction for grade I and II discontinue drug for grade III and IV |