Pentoxifylline Role Against Chemotherapy-induced Neuropathy

Not Applicable

Completed

• Conditions: Chemotherapy-induced Peripheral Neuropathy
• Interventions: Drug: Pentoxifylline

• Registration Number: NCT06562998
• Lead Sponsor: Beni-Suef University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-01
• Primary Completion: 2024-04-01
• Status Verified: 2024-08
• Study Completion: 2024-08-01
• Study First Submitted: 2024-08-18
• Study First Submitted QC: 2024-08-18
• Last Update Submitted: 2024-08-18
• Study First Posted: 2024-08-20
• Last Update Posted: 2024-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 72

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PTX group	Pentoxifylline	paclitaxel based regimens plus Pentoxifylline 400mg twice daily for 12weeks.
Control group	Pentoxifylline	include those assigned for Taxol-based chemotherapy without intervention for 12 weeks

Primary Outcome Measures

Name	Time	Method
The Functional Assessment of Cancer Therapy/Gynecologic Oncology Group Neurotoxicity(FACT-GOG-NTX) subscale	12 weeks

Secondary Outcome Measures

Name	Time	Method
Common Terminology Criteria for Adverse Events Version 5 (CTCAE v5)	12 weeks

Trial Locations

Locations (1)

University Hospital; 🇪🇬 Banī Suwayf, Beni-Suef, Egypt