Doxorubicin Induced CardiotoxicityPhase 2PTX / BCNCT07137793
Clinical Study to Evaluate The Cardioprotective Effect of Pentoxifylline Against Doxorubicin Induced Cardiotoxicity in Breast Cancer Patients
A Phase 2 study testing Pentoxifylline 400mg plus chemotherapy in people with Doxorubicin Induced Cardiotoxicity and Breast Cancer, run by Tanta University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Doxorubicin Induced Cardiotoxicity, Breast Cancer
- What is being tested?
- Pentoxifylline 400mg plus chemotherapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2025to 23 Sep 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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:
- What is the change in ejection fraction (primary outcome) in breast cancer patients receiving pentoxifylline compared to those who do not?
- 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.
Read more
Participants will:
Be randomized to receive either a chemotherapeutic regimen alone or with pentoxifylline.
- Conditions
- Doxorubicin Induced Cardiotoxicity, Breast Cancer
- Being tested
- Pentoxifylline 400mg plus chemotherapy
- Keywords
- pentoxyfillne, breast cancer, cardioprotective, Doxorubicin Induced Cardiotoxicity
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pentoxifylline 400mg plus chemotherapyDrug
patient will receive standard chemotherapy for breast cancer plus pentoxifylline 400 mg orally 3 times per day with meals.
| Study group | Role | What they receive |
|---|---|---|
| Positive control group receiving standard chemotherapy for breast cancer . | No intervention | Not described |
| Pentoxifylline 400mg plus chemotherapy | Active comparator | Not described Receives: Drug: Pentoxifylline 400mg plus chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in ejection fraction
Measured: 3 MONTHS
Secondary outcomes (1)
changes in serum levels of the measured biological markers
Measured: 3 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start1 Sep 2025
- Primary completion15 Mar 2026
- Study completion23 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Doxorubicin Induced CardiotoxicityStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sondos Mahmoud Elfeky, Tanta University
- Investigators
- Dalia Refaat Mohamed Elafify Dr, Study chair, Tanta UniversityEman Ibrahim Elberri Lecturer, Study director, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07137793
- Sponsor's protocol ID
- TP/RE/5/25M-006
- Acronym
- PTX / BC
- Status last verified
- Sep 2026
- First submitted
- 15 Aug 2025
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 31972363Dezube 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.
PubMed 7678547Fernandes 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.
PubMed 17196208
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate The Cardioprotective Effect of Pentoxifylline Against Doxorubicin Induced Cardiotoxicity in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT07137793
- Acronym / sponsor ID
- PTX / BC / TP/RE/5/25M-006
- Conditions
- Doxorubicin Induced Cardiotoxicity, Breast Cancer
- Keywords
- pentoxyfillne, breast cancer, cardioprotective, Doxorubicin Induced Cardiotoxicity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 15 Mar 2026 (actual)
- Study completion
- 23 Sep 2026 (actual)
- First posted
- 22 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- What is the change in ejection fraction (primary outcome) in breast cancer patients receiving pentoxifylline compared to those who do not?
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positive control group receiving standard chemotherapy for breast cancer . | No intervention | – |
| Pentoxifylline 400mg plus chemotherapy | Active comparator | Drug: Pentoxifylline 400mg plus chemotherapy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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%.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pentoxifylline 400mg plus chemotherapypatient will receive standard chemotherapy for breast cancer plus pentoxifylline 400 mg orally 3 times per day with meals. | Drug | Pentoxifylline 400mg plus chemotherapy |
Primary outcome
change in ejection fraction
Time frame: 3 MONTHS
1 secondary outcome
changes in serum levels of the measured biological markers
Time frame: 3 MONTHS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Background: PubMed 31972363Matboli 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.
- Background: PubMed 7678547Dezube 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.
- Background: PubMed 17196208Fernandes 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dalia Refaat Mohamed Elafify Dr study chair
Tanta University
Eman Ibrahim Elberri Lecturer study director
Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pentoxifylline 400mg plus chemotherapy in people with Doxorubicin Induced Cardiotoxicity and Breast Cancer, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in ejection fraction (time frame: 3 MONTHS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07137793, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.