A Study to See if Duloxetine Can Reduce Nerve Problems Caused by Paclitaxel Chemotherapy

Prophylactic Duloxetine For Prevention of Paclitaxel Induced Peripheral Neuropathy A Randomized Trial - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/04/108345

Enrollment

116

Registered

2026-04-13

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C50-C50- Malignant neoplasms of breast Health Condition 2: C561- Malignant neoplasm of right ovary Health Condition 3: C562- Malignant neoplasm of left ovary Health Condition 4: C348- Malignant neoplasm of overlappingsites of bronchus and lung

Interventions

Intervention1: 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

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Change in patient-reported neuropathic symptoms from baseline to the end of treatment between the intervention and control groups using EORTC QLQ CIPN20 questionnaireTimepoint: 13 months	—

Secondary

Measure	Time frame
Incidence NCI-CTCAE version 5.0 of Grade more than or equal to 2 between the two groupsTimepoint: 13 months;To compare proportion of patients requiring paclitaxel dose reduction, delay, or discontinuation due to neurotoxicityTimepoint: 13 months;Incidence and severity of adverse events related to duloxetine with paclitaxel chemotherapy.Timepoint: 13 months	—

Countries

India

Contacts

Public ContactDr Ram Abhinav

Kovai Medical Center and Hospital

drramabhinav@kmchhospitals.com9769109868

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026