Pentoxifylline Role Against Chemotherapy-induced Neuropathy

August 18, 2024 updated by: Hasnaa Osama, Beni-Suef University

Pentoxifylline Prophylactic Role Against Paclitaxel 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Beni-Suef
      • Banī Suwayf, Beni-Suef, Egypt, 13556
        • University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: PTX group
paclitaxel based regimens plus Pentoxifylline 400mg twice daily for 12weeks.
Drug: Pentoxifylline
Pentoxifylline 400mg twice daily plus paclitaxel based regimens for 12weeks.
Placebo Comparator: Control group
include those assigned for Taxol-based chemotherapy without intervention for 12 weeks
Drug: Pentoxifylline
Pentoxifylline 400mg twice daily plus paclitaxel based regimens for 12weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The Functional Assessment of Cancer Therapy/Gynecologic Oncology Group Neurotoxicity(FACT-GOG-NTX) subscale
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Common Terminology Criteria for Adverse Events Version 5 (CTCAE v5)
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beni-Suef University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2022

Primary Completion (Actual)

April 1, 2024

Study Completion (Actual)

August 1, 2024

Study Registration Dates

First Submitted

August 18, 2024

First Submitted That Met QC Criteria

August 18, 2024

First Posted (Actual)

August 20, 2024

Study Record Updates

Last Update Posted (Actual)

August 20, 2024

Last Update Submitted That Met QC Criteria

August 18, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMBSUREC/07072024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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