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

NCT06176339 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2024-03-15

No results posted yet for this study

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

Interventions

DRUG

Pentoxifylline Oral Tablet

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Principal Investigators

  • Omar Hamdy Abdelaleem, PhD · Oncology Center, Faculty of medicine, Mansoura University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-15
Primary Completion
2024-08-30
Completion
2024-09-30
FDA Drug
Yes

Countries

  • Egypt

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06176339 on ClinicalTrials.gov