| CTRI Number |
CTRI/2026/04/108345 [Registered on: 13/04/2026] Trial Registered Prospectively |
| Last Modified On: |
03/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study to See if Duloxetine Can Reduce Nerve Problems Caused by Paclitaxel Chemotherapy |
|
Scientific Title of Study
|
Prophylactic Duloxetine For Prevention of Paclitaxel Induced Peripheral Neuropathy A Randomized Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Arjuhn R |
| Designation |
DrNB Medical Oncology |
| Affiliation |
Kovai Medical Center and Hospital |
| Address |
Department of Medical oncology,
Medical oncology OPD,
99, Avanashi Road, Kovai Medical Center and Hospital, Coimbatore
Coimbatore
TAMIL NADU
641014
India |
| Phone |
9677782210 |
| Fax |
|
| Email |
mmcarju@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ram Abhinav |
| Designation |
Consultant, Medical Oncology |
| Affiliation |
Kovai Medical Center and Hospital |
| Address |
Department of Medical oncology,
Medical oncology OPD,
99, Avanashi Road, Kovai Medical Center and Hospital, Coimbatore
Coimbatore
TAMIL NADU
641014
India |
| Phone |
9769109868 |
| Fax |
|
| Email |
drramabhinav@kmchhospitals.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ram Abhinav |
| Designation |
Consultant, Medical Oncology |
| Affiliation |
Kovai Medical Center and Hospital |
| Address |
Department of Medical oncology,
Medical oncology OPD,
99, Avanashi Road, Kovai Medical Center and Hospital, Coimbatore
Coimbatore
TAMIL NADU
641014
India |
| Phone |
9769109868 |
| Fax |
|
| Email |
drramabhinav@kmchhospitals.com |
|
|
Source of Monetary or Material Support
|
| 99, Avanashi Road, Kovai Medical Center and Hospital, Coimbatore-641014 |
|
|
Primary Sponsor
|
| Name |
Dr Arjuhn R |
| Address |
99, Avanashi Road, Kovai Medical Center and Hospital, Coimbatore 641014 |
| Type of Sponsor |
Other [ Investigator Initiated Trial] |
|
|
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 Arjuhn R |
Kovai Medical Center and Hospital |
Department of Medical Oncology, Kovai Medical
Center Hospital, Coimbatore
Coimbatore
TAMIL NADU |
9677782210
mmcarju@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KMCH Institutional Ethical Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C50-C50||Malignant neoplasms of breast, (2) ICD-10 Condition: C561||Malignant neoplasm of right ovary, (3) ICD-10 Condition: C562||Malignant neoplasm of left ovary, (4) ICD-10 Condition: C348||Malignant neoplasm of overlappingsites of bronchus and lung, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Duloxetine |
Duloxetine 30 mg once
daily, starting on the first day of their first paclitaxel cycle. Duloxetine will
be continued throughout the paclitaxel chemotherapy regimen and for 4
weeks after the last dose of paclitaxel |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Adult patients (age more than or equal to 18 years) with histologically confirmed solid
tumor (breast, ovarian, lung) scheduled to receive paclitaxel based chemotherapy.
2. Eastern Cooperative Oncology Group performance status of 0 to 2.
3. Adequate bone marrow, hepatic, and renal function |
|
| ExclusionCriteria |
| Details |
1. Pre-existing peripheral neuropathy of any etiology (NCI-CTCAE Grade more than or equal to 2)
2. History of significant psychiatric illness (bipolar disorder, active major depressive disorder).
3. Uncontrolled narrow-angle glaucoma.
4. Severe hepatic impairment (as defined by the investigator).
5. Current use of medications with significant serotonergic effects
(SSRIs, SNRIs, tramadol) within 30 days of randomization.
6. Pregnancy or breastfeeding. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in patient-reported neuropathic symptoms from
baseline to the end of treatment between the intervention and control groups using EORTC QLQ CIPN20 questionnaire |
13 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Incidence NCI-CTCAE version
5.0 of Grade more than or equal to 2 between the two groups |
13 months |
To compare proportion of patients requiring paclitaxel dose reduction,
delay, or discontinuation due to neurotoxicity |
13 months |
Incidence and severity of adverse events related to duloxetine
with paclitaxel chemotherapy. |
13 months |
|
|
Target Sample Size
|
Total Sample Size="116"
Sample Size from India="116"
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)
|
30/04/2026 |
| 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="1"
Months="1"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [mmcarju@gmail.com].
- For how long will this data be available start date provided 27-01-2026 and end date provided 27-03-2030?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study is a randomized, open label, parallel group, single centre trial comparing the efficacy and safety of prophylactic duloxetine 30 mg once daily versus standard care alone for the prevention of paclitaxel-induced peripheral neuropathy. The study will be conducted over a period of 13 months at a tertiary care oncology centre in India. A total of 116 patients with solid tumors receiving paclitaxel-based chemotherapy will be enrolled and randomized in a 1:1 ratio. The primary outcome measure will be the change in patient-reported neuropathy symptoms as assessed by the EORTC QLQ-CIPN20 score from baseline to four weeks after completion of paclitaxel therapy. Secondary outcome measures will include the incidence of clinician-graded peripheral neuropathy (NCI-CTCAE version 5.0), the proportion of patients requiring paclitaxel dose modification due to neurotoxicity, and the safety and tolerability of duloxetine during chemotherapy |