Status:
COMPLETED
"Prevention of Paclitaxel-Induced Peripheral Neuropathy in Breast Cancer Patients"
Lead Sponsor:
Ain Shams University
Conditions:
Breast Cancer Female
Peripheral Neuropathy
Eligibility:
FEMALE
18-80 years
Phase:
PHASE2
PHASE3
Brief Summary
The aim of this study is to evaluate the effect of pentoxifylline 400 mg twice daily administration on the prevention of paclitaxel-Induced peripheral neuropathy in breast cancer patients.
Detailed Description
Paclitaxel induced peripheral neuropathy (PIPN) starts early during therapy and may worsen even after cessation and affect mainly sensory neurons. The symptoms of neuropathy include pain, tingling, co...
Eligibility Criteria
Inclusion
- Adult patients (18-80 years old).
- Female patients.
- Pathologically proved breast cancer.
- Breast cancer patients who will receive adjuvant and neoadjuvant weekly paclitaxel for 12 weeks.
- Eastern Cooperative Oncology Group (ECOG) performance ≤ 2
- Adequate bone marrow function.
- Adequate liver and kidney function.
Exclusion
- Patients with preexisting clinical neuropathy.
- Patients with diabetes mellitus.
- Metastatic breast cancer.
- Patients receiving medications that ameliorate neuropathy like; antidepressants, anticonvulsants, opioids, adjuvant or topical analgesics.
- Patients treated with medications that increase the risk of neuropathy.
- Hypersensitivity to pentoxifylline or xanthine derivatives.
- Patients with recent (within 1 month) surgery, myocardial infarction (MI), intracranial or retinal bleeding or active peptic ulcer.
- Patients at high risk for bleeding or taking medications that increase risk of bleeding.
Key Trial Info
Start Date :
October 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 28 2023
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT05189535
Start Date
October 3 2021
End Date
September 28 2023
Last Update
January 23 2024
Active Locations (1)
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1
Ain Shams University hospitals
Cairo, Abbasia, Egypt, 11566