Assessing the Clinical Utility of Adding Pentoxifylline to Neoadjuvant Chemotherapy Protocols in Breast Cancer Patients"

NCT ID: NCT06176339

Last Updated: 2024-03-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-15
• Study Completion Date: 2024-09-30

Brief Summary

Breast cancer, a leading cause of cancer-related mortality in women worldwide, has spurred the investigation of novel therapeutic approaches. Pentoxifylline (PTX), a synthetic methylxanthine derivative, has shown promise in preclinical studies when combined with conventional anticancer drugs. This study aims to assess PTX's impact when added to neoadjuvant chemotherapy protocols in breast cancer patients, with the goal of improving treatment outcomes and reducing associated toxicities.

Conditions

Breast Cancer Female

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Pentoxyphyllin group

Patients will undergo a treatment plan determined by the multidisciplinary team. This involves four cycles of intravenous (IV) doxorubicin at a dose of 60 mg/m2 along with IV cyclophosphamide at 600 mg/m2 per cycle. Following this, taxane will be administered. Additionally, patients are prescribed 400 mg pentoxifylline tablets to be taken three times daily.

Group Type: ACTIVE_COMPARATOR

Pentoxifylline Oral Tablet

Intervention Type: DRUG

Pentoxifylline 400 mg extended-release oral tablets will be administered orally three times per day through the chemotherapy cycles.

Control group

Patients will undergo a treatment plan determined by the multidisciplinary team. This involves four cycles of intravenous (IV) doxorubicin at a dose of 60 mg/m2 along with IV cyclophosphamide at 600 mg/m2 per cycle. Following this, taxane will be administered. Additionally, patients will take placebo tablets three times daily.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo tablets will be administered orally three times per day through the time of the chemotherapy cycles.

Interventions

Pentoxifylline Oral Tablet

Pentoxifylline 400 mg extended-release oral tablets will be administered orally three times per day through the chemotherapy cycles.

Intervention Type: DRUG

Placebo

Placebo tablets will be administered orally three times per day through the time of the chemotherapy cycles.

Intervention Type: DRUG

Other Intervention Names

Intravenous doxorubicin; Intravenous cyclophosphamide; Intravenous taxane; Intravenous doxorubicin; Intravenous cyclophosphamide; Intravenous taxane

Eligibility Criteria

Inclusion Criteria

• Adult female patients >18 years old with histologic confirmation of invasive breast cancer
• Planned to administer neoadjuvant chemotherapy protocol comprised of doxorubicin/ cyclophosphamide followed by paclitaxel (AC/T)
• Adequate hepatic, renal, and bone marrow functions

Exclusion Criteria

• Patients on treatment regimen of phosphodiesterase inhibitors
• Patients who are taking antiplatelet or anticoagulant treatment
• Patients who are allergic to phosphodiesterase inhibitors
• History of recent hemorrhagic events
• Active peptic ulcer

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Omar Hamdy

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Omar Hamdy Abdelaleem, PhD

Role: PRINCIPAL_INVESTIGATOR

Oncology Center, Faculty of medicine, Mansoura University

Locations

Oncology center of Mansoura University

Al Mansurah, , Egypt

Countries

Egypt

Other Identifiers

2023-147-1

Identifier Type: -

Identifier Source: org_study_id