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

Breast Cancer Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06176339
• Other study ID #: 2023-147-1
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: December 15, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: March 2024
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: September 30, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer Female
• Breast Neoplasms

Intervention

Drug:
• Pentoxifylline Oral Tablet
Pentoxifylline 400 mg extended-release oral tablets will be administered orally three times per day through the chemotherapy cycles.
• Placebo
Placebo tablets will be administered orally three times per day through the time of the chemotherapy cycles.

Locations

Country	Name	City	State
Egypt	Oncology center of Mansoura University	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relative reduction in tumor size after neoadjuvant chemotherapy treatment	Radiological relative reduction of tumor size (expressed as the largest diameter in millimeters) after completion of neoadjuvant chemotherapy cycles.	6 months
Secondary	The number of patients achieving a pathological complete response	The number of patients achieving a pathological complete response after the completion of neoadjuvant chemotherapy cycles	6 months
Secondary	The relative change of left ventricular ejection fraction (LVEF)	The alterations in left ventricular ejection fraction (LVEF) assessed through echocardiography after four cycles of doxorubicin/cyclophosphamide compared to its baseline level	3 months
Secondary	The incidence of grade 2 or more of neurotoxicity according to common terminology criteria for adverse event (NCI-CTCAE) version 5	Assessing the grade of neurotoxicity according to common terminology criteria for adverse event (NCI-CTCAE) version 5	2 months
Secondary	The relative change of liver function tests	The change in liver function tests Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), bilirubin level after neoadjuvant chemotherapy compared to their levels at baseline.	6 months
Secondary	The change in Serum Creatinine concentration	The change in Serum Creatinine concentration after neoadjuvant chemotherapy compared to baseline level.	6 months