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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
100
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.
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..
Oncology Center of Mansoura University
Al Mansurah, Egypt
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.
Time frame: 6 months
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
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.