Effect of Pentoxifylline on Preventing Chemotherapy-induced Toxicities in Patients With Breast Cancer

This clinical trial is a randomized clinical trial that aims to assess the usefulness of adding pentoxifylline to the neoadjuvant chemotherapy treatment protocol of doxorubicin/cyclophosphamide fllowed by taxane for breast cancer patients to decrease the incidence of developing toxicities, and enhance the quality of patient life using the EQ-5D-3L questionnaire. The participant will administer Pentoxifylline oral tablets three times per day along with the treatment protocol, starting from the first doxorubicin/cyclophosphamide cycle till the end of the chemotherapy cycles. The researchers will compare the incidence and grade of mucosities, neuropathy, and other chemotherapy-related toxicities in the presence or absence of oral pentoxifylline.

Study Overview

• Status: Completed
• Conditions: Neoadjuvant Therapy; Breast Cancer Female; Breast Cancer Patients; Taxane-induced Peripheral Neuropathy; Doxorubicin
• Intervention / Treatment: Drug: Pentoxifylline 400mg plus chemotherapy; Drug: Chemotherapy

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Mansoura, Egypt
    • Oncology Center of Mansoura University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Adult female patients >18 years old with histologic confirmation of invasive breast cancer
2. Planned to administer neoadjuvant chemotherapy protocol comprised of doxorubicin/ cyclophosphamide followed by paclitaxel (AC/T)
3. Adequate hepatic, renal, and bone marrow functions

Exclusion Criteria:

1. Patients on a treatment regimen of phosphodiesterase inhibitors
2. Patients who are taking antiplatelet or anticoagulant treatment
3. Patients who are allergic to phosphodiesterase inhibitors
4. History of recent hemorrhagic events
5. Active peptic ulcer
6. patients who have mouth or teeth problem.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control group; The patient will take standard neoadjuvant chemotherapy, including doxorubicin/cyclophosphamide, followed by a taxane regimen as per the medical committee.	Drug: Chemotherapy; The patient will take chemotherapy cycle comprised intravenous Doxorubicin 60 mg/m²/cycle with intravenous Cyclophosphamide 600 mg/m²/cycle for four cycles, followed by weekly paclitaxel, dose-dense paclitaxel or docetaxel..
Active Comparator: Pentoxifylline group; The patient will take 400 mg tablets of Pentoxifylline, 3 tablets per day, starting from the first day of the first cycle of doxorubicin/cyclophosphamide till finishing the cycles of neoadjuvant chemotherapy comprised intravenous Doxorubicin 60 mg/m²/cycle with intravenous Cyclophosphamide 600 mg/m²/cycle for four cycles, followed by weekly paclitaxel, dose-dense paclitaxel or docetaxel.	Drug: Pentoxifylline 400mg plus chemotherapy; The patient will take 400 mg tablets of Pentoxifylline, 3 tablets per day, starting from the first day of the first cycle of doxorubicin/cyclophosphamide till finishing the cycles of neoadjuvant chemotherapy comprised intravenous Doxorubicin 60 mg/m²/cycle with intravenous cyclophosphamide 600 mg/m²/cycle for four cycles, followed by weekly paclitaxel, dose-dense paclitaxel or docetaxel.; Other Names: Intravenous doxorubicin; Intravenous cyclophosphamide; Intravenous taxane; oral pentoxifylline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of grade 2 or more peripheral neuropathy in the two groups using Common Terminology Criteria Adverse Event grading	The number of patients reported grade 2 or more peripheral neuropathy in the two groups.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the incidence of gastrointestinal side effects including: abdominal discomfort, bloating, diarrhea, constipation will be assessed in the two groups using Common Terminology Criteria Adverse Event grading		6 months
The incidence of grade 2 or more oral mucositis in the two groups using Common Terminology Criteria Adverse Event grading	The number of patients who reported grade 2 or more oral mucositis adverse effects during the treatment period	6 months
The incidence of grade 2 or more anemia in the two groups using Common Terminology Criteria Adverse Event grading		6 months
The incidence of grade 2 or more febrile neutropenia in the two groups using Common Terminology Criteria Adverse Event grading		6 months

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): December 25, 2023
• Primary Completion (Actual): December 1, 2024
• Study Completion (Actual): December 1, 2024

Study Registration Dates

• First Submitted: December 16, 2023
• First Submitted That Met QC Criteria: December 16, 2023
• First Posted (Actual): January 2, 2024

Study Record Updates

• Last Update Posted (Actual): July 28, 2025
• Last Update Submitted That Met QC Criteria: July 24, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: neoadjuvant chemotherapy, pentoxiphyllin, doxorubicin, cyclophosphamide, mucositis, quality of life
• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms by Site; Neoplasms; Neuromuscular Diseases; Skin Diseases; Breast Diseases; Breast Neoplasms; Peripheral Nervous System Diseases; Antibiotics, Antineoplastic; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antirheumatic Agents; Platelet Aggregation Inhibitors; Topoisomerase Inhibitors; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Topoisomerase II Inhibitors; Antioxidants; Protective Agents; Free Radical Scavengers; Vasodilator Agents; Phosphodiesterase Inhibitors; Radiation-Protective Agents; Cyclophosphamide; Doxorubicin; Pentoxifylline
• Other Study ID Numbers: 2023-147-2

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