Assessing the Clinical Utility of Adding Pentoxifylline to Neoadjuvant Chemotherapy Protocols in Breast Cancer Patients"

Mansoura University70 enrolled

Overview

Breast cancer, a leading cause of cancer-related mortality in women worldwide, has spurred the investigation of novel therapeutic approaches. Pentoxifylline (PTX), a synthetic methylxanthine derivative, has shown promise in preclinical studies when combined with conventional anticancer drugs. This study aims to assess PTX's impact when added to neoadjuvant chemotherapy protocols in breast cancer patients, with the goal of improving treatment outcomes and reducing associated toxicities.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Breast Cancer Female

Interventions

Pentoxifylline Oral TabletDRUG

Pentoxifylline 400 mg extended-release oral tablets will be administered orally three times per day through the chemotherapy cycles.

PlaceboDRUG

Placebo tablets will be administered orally three times per day through the time of the chemotherapy cycles.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult female patients \>18 years old with histologic confirmation of invasive breast cancer * Planned to administer neoadjuvant chemotherapy protocol comprised of doxorubicin/ cyclophosphamide followed by paclitaxel (AC/T) * Adequate hepatic, renal, and bone marrow functions Exclusion Criteria: * Patients on treatment regimen of phosphodiesterase inhibitors * Patients who are taking antiplatelet or anticoagulant treatment * Patients who are allergic to phosphodiesterase inhibitors * History of recent hemorrhagic events * Active peptic ulcer

Locations (1)

Oncology center of Mansoura University

Al Mansurah, Egypt

Outcomes

Primary Outcomes

Relative reduction in tumor size after neoadjuvant chemotherapy treatment

Radiological relative reduction of tumor size (expressed as the largest diameter in millimeters) after completion of neoadjuvant chemotherapy cycles.

Time frame: 6 months

Secondary Outcomes

The number of patients achieving a pathological complete response

The number of patients achieving a pathological complete response after the completion of neoadjuvant chemotherapy cycles

Time frame: 6 months

The relative change of left ventricular ejection fraction (LVEF)

The alterations in left ventricular ejection fraction (LVEF) assessed through echocardiography after four cycles of doxorubicin/cyclophosphamide compared to its baseline level

Time frame: 3 months

The incidence of grade 2 or more of neurotoxicity according to common terminology criteria for adverse event (NCI-CTCAE) version 5

Assessing the grade of neurotoxicity according to common terminology criteria for adverse event (NCI-CTCAE) version 5

Time frame: 2 months

The relative change of liver function tests

The change in liver function tests Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), bilirubin level after neoadjuvant chemotherapy compared to their levels at baseline.

Time frame: 6 months

The change in Serum Creatinine concentration

The change in Serum Creatinine concentration after neoadjuvant chemotherapy compared to baseline level.

Time frame: 6 months

Data from ClinicalTrials.gov

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