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

Phase 2

Completed

• Conditions: Breast Cancer Female; Breast Cancer Patients; Neoadjuvant Therapy; Doxorubicin; Taxane-induced Peripheral Neuropathy
• Interventions: Drug: Pentoxifylline 400mg plus chemotherapy; Drug: Chemotherapy

• Registration Number: NCT06186700
• Lead Sponsor: Mansoura University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-16
• Study First Submitted QC: 2023-12-16
• Study Start: 2023-12-25
• Study First Posted: 2024-01-02
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-13
• Last Update Posted: 2025-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pentoxifylline group	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 or dose-dense paclitaxel.
Control group	Chemotherapy	The patient will take standard neoadjuvant chemotherapy, including doxorubicin/cyclophosphamide, followed by a taxane regimen as per the medical committee.

Primary Outcome Measures

Name	Time	Method
The incidence of neuropathy in the two groups using Common Terminology Criteria Adverse Event grading	6 months	The number of patients reported oral neuropathy in the two groups.

Secondary Outcome Measures

Name	Time	Method
The incidence of oral mucositis in the two groups using Common Terminology Criteria Adverse Event grading	6 months	The number of patients who reported oral mucositis adverse effects during the treatment period
The incidence of anemia in the two groups using Common Terminology Criteria Adverse Event grading	6 months
The incidence of 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

Trial Locations

Locations (1)

Oncology Center of Mansoura University; 🇪🇬 Mansoura, Egypt