Clinical Study to Evaluate The Cardioprotective Effect of Pentoxifylline Against Doxorubicin Induced Cardiotoxicity in Breast Cancer Patients

NCT07137793 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: TP/RE/5/25M-006
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate the cardioprotective effect of pentoxifylline against doxorubicin-induced cardiotoxicity in breast cancer patients. The main questions it aims to answer are:

1. 1.What is the change in ejection fraction (primary outcome) in breast cancer patients receiving pentoxifylline compared to those who do not?
2. 2.What are the changes in serum levels of N-terminal pro-B-type natriuretic peptide (NT-pro-BNP), and TNF-α (secondary outcomes) in breast cancer patients receiving pentoxifylline compared to those who do not? Researcher will compare breast cancer patients receiving standard chemotherapy alone (Group one: Positive control group; n=23) to breast cancer patients receiving standard chemotherapy plus pentoxifylline (Group two: pentoxifylline group; n=23) to see if pentoxifylline mitigates the cardiac side effects associated with doxorubicin treatment.

Conditions

Doxorubicin Induced Cardiotoxicity; Breast Cancer

Keywords

pentoxyfillne; breast cancer; cardioprotective; Doxorubicin Induced Cardiotoxicity

Outcome Measures

Primary Outcomes (1)

• change in ejection fraction

  3 MONTHS

Secondary Outcomes (1)

• changes in serum levels of the measured biological markers

  3 MONTHS

Study Arms (2)

Positive control group receiving standard chemotherapy for breast cancer .

NO INTERVENTION

Pentoxifylline 400mg plus chemotherapy

ACTIVE COMPARATOR

Drug: Pentoxifylline 400mg plus chemotherapy

Interventions

Pentoxifylline 400mg plus chemotherapy DRUG

patient will receive standard chemotherapy for breast cancer plus pentoxifylline 400 mg orally 3 times per day with meals.

Pentoxifylline 400mg plus chemotherapy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: Females with breast cancer
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age ≥18 years old.
• Chemo-naïve patients with biopsy confirmed diagnosis of breast cancer and with stage I-III breast cancer according to the American Joint Committee on Cancer (TNM staging system of breast cancer).
• Patients intended to receive at least 4 cycles of doxorubicin or more.
• Patients with performance status \<2 according to Eastern Cooperative Oncology Group (ECOG) score.
• Echocardiographic LVEF ≥55%.
• Adequate baseline hematologic values (absolute neutrophilic count ≥ 1.5 ×109/L, platelet count ≥ 90 × 109/L and hemoglobin level ≥ 10 g/dl).
• Patients with adequate liver function and adequate renal function.
• Signed informed consent to participate in the study.

You may not qualify if:

• Age \<18 years old and \>65 years old.
• Women with history of breast cancer.
• Formerly treated with DOX.
• Patients with a known hypersensitivity to any of the used drugs.
• Treatment with blood thinners for 6 months prior to the screening.
• Treatment with NSAIDS like ketorolac,ibuprofen.
• Patients taking any other cardioprotective medications.
• Pregnancy and breast feeding.
• Alcohol abuse.
• Creatine Clearance \< 50 mL/min.
• History of heart failure or LVEF \<50%.
• Presence of any cardiac-related conditions such as angina pectoris, valvular disease, uncontrolled systemic hypertension, coronary heart disease, and cardiac surgery within the last 3 months.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Damnhour Oncology Center

Damanhūr, Egypt

RECRUITING

Related Publications (3)

• Matboli M, Habib EK, Hussein Mohamed R, Mahran NA, Seleem HS, Nosseir N, Hasanin AH. Pentoxifylline alleviated cardiac injury via modulating the cardiac expression of lncRNA-00654-miR-133a-SOX5 mRNA in the rat model of ischemia-reperfusion. Biomed Pharmacother. 2020 Apr;124:109842. doi: 10.1016/j.biopha.2020.109842. Epub 2020 Jan 20.

  PMID: 31972363 BACKGROUND

• Dezube BJ, Sherman ML, Fridovich-Keil JL, Allen-Ryan J, Pardee AB. Down-regulation of tumor necrosis factor expression by pentoxifylline in cancer patients: a pilot study. Cancer Immunol Immunother. 1993;36(1):57-60. doi: 10.1007/BF01789132.

  PMID: 7678547 BACKGROUND

• Fernandes JL, de Oliveira RTD, Mamoni RL, Coelho OR, Nicolau JC, Blotta MHSL, Serrano CV Jr. Pentoxifylline reduces pro-inflammatory and increases anti-inflammatory activity in patients with coronary artery disease--a randomized placebo-controlled study. Atherosclerosis. 2008 Jan;196(1):434-442. doi: 10.1016/j.atherosclerosis.2006.11.032. Epub 2006 Dec 28.

  PMID: 17196208 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Pentoxifylline; Drug Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Sahar kamal Hegazy professor

  Tanta University

  STUDY CHAIR

• Eman Ibrahim Elberri Lecturer

  Tanta University

  STUDY DIRECTOR

Central Study Contacts

sondos mahmoud elfeky, bachelor degree in pharmacy

CONTACT

01148031701; sonddoselfiqy@gmail.com

Sahar kamal Hegazy professor

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: bachelor

Study Record Dates

• First Submitted: August 15, 2025
• First Posted: August 22, 2025
• Study Start: May 25, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 22, 2025

Record last verified: 2025-08

Locations

EG (1)