breast cancer. Malignant neoplasm of breast
Conditions
Interventions
Intervention 1: intervention group: duloxetine capsule (Duloxicap produced by Tadbir Kala-e Jam pharmaceutical company) taken orally 30 mg daily starting with first dose of Paclitaxel till 2 weeks aft
Treatment - Drugs
Placebo
intervention group: duloxetine capsule (Duloxicap produced by Tadbir Kala-e Jam pharmaceutical company) taken orally 30 mg daily starting with first dose of Paclitaxel till 2 weeks after last course o
control group: placebo of duloxetine PO daily starting with first dose of Paclitaxel till 2 weeks after last course of Paclitaxe
Sponsors
Breast Cancer Research Center of Jahad Daneshgahi
Tadbir Kalay-e Jam Pharmaceutical Company
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: inclusion criteria: -patient receiving paclitaxel -it is the first dose of paclitaxel -prior or ongoing treatment with other neurotoxic chemotherapic agents is not allowed -participants with out any documented medical history of nerve compression, leptomeningeal carcinomatosis, severe depression, suicidal idea, bipolar disease, alcohol abuse, glaucoma, diabetes, thyroid abnormality, markedly abnormal renal or liver function tests - not taking any medicine interfere in serotonin level -not taking any analgesic medicine routinely in two weeks before entering the trial exclusion criteria: -sever complications with duloxetine
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neuropathy. Timepoint: before satrting intervention and 6-12-24 weeks after that. Method of measurement: NCI-CTCAE and FACT-TAXAN questionnaire. | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life. Timepoint: before starting intervention and in 6-12-24 weeks after that. Method of measurement: FACT-TAXAN questionnaire. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr Azin Ahmari
Shahid Beheshty University of Medical Sciences
Outcome results
None listed