Effect of Pentoxifylline on Preventing Chemotherapy-induced Toxicities in Patients With Breast Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-25

Study Completion Date

2024-12-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Cancer Female Breast Cancer Patients Neoadjuvant Therapy Doxorubicin Taxane-induced Peripheral Neuropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Pentoxifylline group

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.

Group Type ACTIVE_COMPARATOR

Pentoxifylline 400mg plus chemotherapy

Intervention Type DRUG

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.

Control group

The patient will take standard neoadjuvant chemotherapy, including doxorubicin/cyclophosphamide, followed by a taxane regimen as per the medical committee.

Group Type OTHER

Chemotherapy

Intervention Type DRUG

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..

Interventions

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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.

Intervention Type 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..

Intervention Type DRUG

Other Intervention Names

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Intravenous doxorubicin Intravenous cyclophosphamide Intravenous taxane oral pentoxifylline

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No