Pentoxifylline Role Against Chemotherapy-induced Neuropathy

NCT06562998 | Completed

• 1 other identifier: FMBSUREC/07072024
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Chemotherapy-induced Peripheral Neuropathy

Outcome Measures

Primary Outcomes (1)

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

  12 weeks

Secondary Outcomes (1)

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

  12 weeks

Study Arms (2)

PTX group

ACTIVE COMPARATOR

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

Drug: Pentoxifylline

Control group

PLACEBO COMPARATOR

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

Drug: Pentoxifylline

Interventions

Pentoxifylline DRUG

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

Control group; PTX group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

University Hospital

Banī Suwayf, Beni Suweif Governorate, 13556, Egypt

Location

Related Publications (1)

• Kidwani MA, Osama H, Hassan A, Abdelrahim MEA. Prophylactic role of pentoxifylline against paclitaxel-induced neuropathy among patients with breast cancer: a randomized-controlled trial. Anticancer Drugs. 2025 Feb 1;36(2):126-134. doi: 10.1097/CAD.0000000000001666. Epub 2024 Oct 16.

  PMID: 39423312 DERIVED

MeSH Terms

Interventions

Pentoxifylline

Intervention Hierarchy (Ancestors)

Theobromine; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of clinical pharmacy

Study Record Dates

• First Submitted: August 18, 2024
• First Posted: August 20, 2024
• Study Start: July 1, 2022
• Primary Completion: April 1, 2024
• Study Completion: August 1, 2024
• Last Updated: August 20, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)