Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
Conditions
Interventions
Intervention1: Duloxetine: Duloxetine 30 mg, oral administration, once daily for 7 days following the paclitaxel infusion in a patient with breast cancer
Control Intervention1: Placebo: Matched placeb
Sponsors
Indian Council of Medical Resaerch
Eligibility
Inclusion criteria
Inclusion criteria: 1. Commencing paclitaxel at a planned dose of 175 mg/m2 as single-agent chemotherapy 2. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 3. Study treatment is both planned and able to start within 14 days of randomization 4. Willing and able to comply with all study requirements, including treatment (taking duloxetine orally), timing and/or nature of required assessments
Exclusion criteria
Exclusion criteria: 1. The patients with pre-existing chronic pain or peripheral neuropathy 2. History of hypersensitivity to paclitaxel 3. Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of acute pain syndrome after paclitaxel administrationTimepoint: At the end of Cycle 1 of paclitaxel (day 14 or end of week 2) | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of patients who develop peripheral neuropathy across the two arms. Timepoint: At baseline, 3rd, 5th, 7th, & 9th week. | — |
Countries
India
Contacts
Public ContactAtul Batra
All India Institute of Medical Science, New Delhi
Outcome results
None listed