Pentoxifylline Role Against Chemotherapy-induced Neuropathy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2024-08-01

Brief Summary

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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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Detailed Description

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Conditions

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Chemotherapy-induced Peripheral Neuropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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PTX group

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

Group Type ACTIVE_COMPARATOR

Pentoxifylline

Intervention Type DRUG

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

Control group

include those assigned for Taxol-based chemotherapy without intervention for 12 weeks

Group Type PLACEBO_COMPARATOR

Pentoxifylline

Intervention Type DRUG

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

Interventions

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Pentoxifylline

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No