Trials / Completed
CompletedNCT06186700
Effect of Pentoxifylline on Preventing Chemotherapy-induced Toxicities in Patients With Breast Cancer
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (actual)
- Sponsor
- Mansoura University · Academic / Other
- Sex
- Female
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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 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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Pentoxifylline 400mg plus chemotherapy | 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. |
| DRUG | Chemotherapy | 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.. |
Timeline
- Start date
- 2023-12-25
- Primary completion
- 2024-12-01
- Completion
- 2024-12-01
- First posted
- 2024-01-02
- Last updated
- 2025-07-28
Locations
1 site across 1 country: Egypt
Source: ClinicalTrials.gov record NCT06186700. Inclusion in this directory is not an endorsement.