Chemotherapy-induced Peripheral Neuropathy
Conditions
Brief summary
Chemotherapy-induced peripheral neuropathy (CIPN) is a common and debilitating side effect of neurotoxic cancer treatment. Estimated to occur in up to 80% of paclitaxel-treated patients with breast cancer, neuropathy symptoms can interfere with function, increasing the risk of falls and reducing quality of life. To date, there are no approved medications for the prevention and/or treatment of CIPN. The objective of the present study is to investigate the beneficial effects of pentoxifylline (PTX) against CIPN in breast cancer patients.
Interventions
DRUGPentoxifylline
Pentoxifylline 400mg twice daily plus paclitaxel based regimens for 12weeks.
Sponsors
Beni-Suef University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Adult patients\> 18 years old. * Female patients Breast cancer patients who received paclitaxel-based regimen for 12 weeks. * Eastern Cooperative Oncology Group (ECOG) performance ≤ 2-Adequate bone marrow function. * Adequate liver and kidney function.
Exclusion criteria
* Children less than 18 years old. * Evidence of physical diseases or major surgery. * Patientswith a history of chronic diseases including; renal, hepatic, gastrointestinal, respiratory, hematological, and metabolic or other diseases. * 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 retinal bleeding or active peptic ulcer. * Patients at high risk for bleeding or taking medications that increase risk of bleeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Functional Assessment of Cancer Therapy/Gynecologic Oncology Group Neurotoxicity(FACT-GOG-NTX) subscale | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Common Terminology Criteria for Adverse Events Version 5 (CTCAE v5) | 12 weeks |
Countries
Egypt
Outcome results
None listed