Breast Cancer FemalePhase 2NCT06186700
Effect of Pentoxifylline on Preventing Chemotherapy-induced Toxicities in Patients With Breast Cancer
A Phase 2 study testing Pentoxifylline 400mg plus chemotherapy and Chemotherapy in people with Breast Cancer Female and Breast Cancer Patients, run by Mansoura University at 1 site in Egypt.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Cancer Female, Breast Cancer Patients, Neoadjuvant Therapy
- What is being tested?
- Pentoxifylline 400mg plus chemotherapy and Chemotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Dec 2023to 1 Dec 2024
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients on a 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
- patients who have mouth or teeth problem.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Breast Cancer Female, Breast Cancer Patients, Neoadjuvant Therapy, Doxorubicin, Taxane-induced Peripheral Neuropathy
- Being tested
- Pentoxifylline 400mg plus chemotherapy, Chemotherapy
- Keywords
- neoadjuvant chemotherapy, pentoxiphyllin, doxorubicin, cyclophosphamide, mucositis, quality of life
- Medical subject headings
- Mucositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pentoxifylline 400mg plus chemotherapyDrug
Also called Intravenous doxorubicin, Intravenous cyclophosphamide, Intravenous taxane, oral pentoxifylline
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.
ChemotherapyDrug
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..
| Study group | Role | What they receive |
|---|---|---|
| Pentoxifylline group | Active comparator | 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. Receives: Drug: Pentoxifylline 400mg plus chemotherapy |
| Control group | Other | The patient will take standard neoadjuvant chemotherapy, including doxorubicin/cyclophosphamide, followed by a taxane regimen as per the medical committee. Receives: Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (4)
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
Measured: 6 months
The incidence of grade 2 or more anemia in the two groups using Common Terminology Criteria Adverse Event grading
Measured: 6 months
The incidence of grade 2 or more febrile neutropenia in the two groups using Common Terminology Criteria Adverse Event grading
Measured: 6 months
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2024
- Study start25 Dec 2023
- Primary completion1 Dec 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Hamdy, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06186700
- Sponsor's protocol ID
- 2023-147-2
- Status last verified
- Feb 2025
- First submitted
- 16 Dec 2023
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dewidar SA, Mansour NO, Hamdy O, Eltantawy A, Soliman MM, Shams MEE. Assessing the efficacy and safety of pentoxifylline in preventing chemotherapy-induced peripheral neuropathy and mucositis in breast cancer patients. Front Pharmacol. 2025 Oct 14;16:1678161. doi: 10.3389/fphar.2025.1678161. eCollection 2025.
PubMed 41164763
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pentoxifylline on Preventing Chemotherapy-induced Toxicities in Patients With Breast Cancer
- ClinicalTrials.gov ID
- NCT06186700
- Acronym / sponsor ID
- 2023-147-2
- Conditions
- Breast Cancer Female, Breast Cancer Patients, Neoadjuvant Therapy, Doxorubicin, Taxane-induced Peripheral Neuropathy
- Keywords
- neoadjuvant chemotherapy, pentoxiphyllin, doxorubicin, cyclophosphamide, mucositis, quality of life
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 25 Dec 2023 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 2 Jan 2024 (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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pentoxifylline group | Active comparator | Drug: Pentoxifylline 400mg plus chemotherapyThe 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. |
| Control group | Other | Drug: ChemotherapyThe patient will take standard neoadjuvant chemotherapy, including doxorubicin/cyclophosphamide, followed by a taxane regimen as per the medical committee. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- Patients on a 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
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 chemotherapyAlso: Intravenous doxorubicin, Intravenous cyclophosphamide, Intravenous taxane, oral pentoxifyllineThe 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 group |
| ChemotherapyThe 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.. | Drug | Control group |
Primary outcome
The incidence of grade 2 or more peripheral neuropathy in the two groups using Common Terminology Criteria Adverse Event grading
Time frame: 6 months
The number of patients reported grade 2 or more peripheral neuropathy in the two groups.
4 secondary outcomes
The incidence of grade 2 or more oral mucositis in the two groups using Common Terminology Criteria Adverse Event grading
Time frame: 6 months
The incidence of grade 2 or more anemia in the two groups using Common Terminology Criteria Adverse Event grading
Time frame: 6 months
The incidence of grade 2 or more febrile neutropenia in the two groups using Common Terminology Criteria Adverse Event grading
Time frame: 6 months
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
Time frame: 6 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 28 Jul 2025.
- Derived from this study: PubMed 41164763Dewidar SA, Mansour NO, Hamdy O, Eltantawy A, Soliman MM, Shams MEE. Assessing the efficacy and safety of pentoxifylline in preventing chemotherapy-induced peripheral neuropathy and mucositis in breast cancer patients. Front Pharmacol. 2025 Oct 14;16:1678161. doi: 10.3389/fphar.2025.1678161. eCollection 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Chemotherapy in people with Breast Cancer Female and Breast Cancer Patients, run by Mansoura 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 3 inclusion and 6 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 28 Jul 2025. 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?
The incidence of grade 2 or more peripheral neuropathy in the two groups using Common Terminology Criteria Adverse Event grading (time frame: 6 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 NCT06186700, which also lists 1 linked publication.
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 28 Jul 2025.