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Completed

NCT Number: NCT06562998

Pentoxifylline Role Against Chemotherapy-induced Neuropathy

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.

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Key information

Conditions

Chemotherapy-induced Peripheral Neuropathy

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital

Banī Suwayf, Beni Suweif Governorate, 13556, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pentoxifylline

Drug

Pentoxifylline 400mg twice daily plus paclitaxel based regimens for 12weeks.

Primary outcomes

  1. The Functional Assessment of Cancer Therapy/Gynecologic Oncology Group Neurotoxicity(FACT-GOG-NTX) subscale

    Time frame: 12 weeks

Secondary outcomes

  1. Common Terminology Criteria for Adverse Events Version 5 (CTCAE v5)

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Registry information

Official study title

Pentoxifylline Prophylactic Role Against Paclitaxel Chemotherapy-induced Neuropathy

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 20, 2024
Registry last updated
Aug 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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