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

NCT06186700 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-07-28

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

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.

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..

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-12-25
Primary Completion
2024-12-01
Completion
2024-12-01

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 NCT06186700 on ClinicalTrials.gov