"Prevention of Paclitaxel-Induced Peripheral Neuropathy in Breast Cancer Patients"

• Status: Recruiting
• Trial end date: 2022-08-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ain Shams University
• Treatments: Paclitaxel; Pentoxifylline

Criteria

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.