"Evaluation of the Effect of Pentoxifylline on the Prevention of Paclitaxel-Induced Peripheral Neuropathy in Breast Cancer Patients"

s2192648

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.

2021-10-03

2023-09-18

2023-09-28

Completed

Early phase I

66

Inclusion Criteria: * 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 Criteria: * 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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A prospective, randomized, placebo controlled', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'single blinded', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 66, 'type': 'ACTUAL'}}

2024-01-23