Breast Cancer Female, Breast Cancer Patients, Doxorubicin, Neoadjuvant Therapy, Taxane-induced Peripheral Neuropathy
Conditions
Keywords
neoadjuvant chemotherapy, pentoxiphyllin, doxorubicin, cyclophosphamide, mucositis, quality of life
Brief 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.
Interventions
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.
DRUGChemotherapy
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..
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Adult female patients \>18 years old with histologic confirmation of invasive breast cancer 2. Planned to administer neoadjuvant chemotherapy protocol comprised of doxorubicin/ cyclophosphamide followed by paclitaxel (AC/T) 3. Adequate hepatic, renal, and bone marrow functions
Exclusion criteria
1. Patients on a treatment regimen of phosphodiesterase inhibitors 2. Patients who are taking antiplatelet or anticoagulant treatment 3. Patients who are allergic to phosphodiesterase inhibitors 4. History of recent hemorrhagic events 5. Active peptic ulcer 6. patients who have mouth or teeth problem.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of grade 2 or more peripheral neuropathy in the two groups using Common Terminology Criteria Adverse Event grading | 6 months | The number of patients reported grade 2 or more peripheral neuropathy in the two groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of grade 2 or more oral mucositis in the two groups using Common Terminology Criteria Adverse Event grading | 6 months | The number of patients who reported grade 2 or more oral mucositis adverse effects during the treatment period |
| The incidence of grade 2 or more anemia in the two groups using Common Terminology Criteria Adverse Event grading | 6 months | — |
| The incidence of grade 2 or more febrile neutropenia in the two groups using Common Terminology Criteria Adverse Event grading | 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 | 6 months | — |
Countries
Egypt
Outcome results
None listed