NCT07137793 Clinical Study to Evaluate The Cardioprotective Effect of Pentoxifylline Against Doxorubicin Induced Cardiotoxicity in Breast Cancer Patients
| NCT ID | NCT07137793 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Tanta University |
| Condition | Doxorubicin Induced Cardiotoxicity |
| Study Type | INTERVENTIONAL |
| Enrollment | 46 participants |
| Start Date | 2025-05-25 |
| Primary Completion | 2026-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 46 participants in total. It began in 2025-05-25 with a primary completion date of 2026-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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. What is the change in ejection fraction (primary outcome) in breast cancer patients receiving pentoxifylline compared to those who do not? 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. Participants will: Be randomized to receive either a chemotherapeutic regimen alone or with pentoxifylline.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Contact & Investigator
Sahar kamal Hegazy professor
STUDY CHAIR
Tanta University
Frequently Asked Questions
Who can join the NCT07137793 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 60 Years, studying Doxorubicin Induced Cardiotoxicity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07137793 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07137793 currently recruiting?
Yes, NCT07137793 is actively recruiting participants. Contact the research team at sonddoselfiqy@gmail.com for enrollment information.
Where is the NCT07137793 trial being conducted?
This trial is being conducted at Damanhūr, Egypt.
Who is sponsoring the NCT07137793 clinical trial?
NCT07137793 is sponsored by Tanta University. The principal investigator is Sahar kamal Hegazy professor at Tanta University. The trial plans to enroll 46 participants.