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NCT Number: NCT06186700

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

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.

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Key information

Conditions

Breast Cancer Female Breast Cancer Patients Digestive System Diseases Doxorubicin Gastroenteritis Gastrointestinal Diseases Mouth Diseases Mucositis Neoadjuvant Therapy Stomatognathic Diseases Taxane-induced Peripheral Neuropathy

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Oncology Center of Mansoura University

Al Mansurah, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 a 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
  • patients who have mouth or teeth problem.

Treatment and study plan

Pentoxifylline 400mg plus chemotherapy

Drug

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.

Other names: Intravenous doxorubicin, Intravenous cyclophosphamide, Intravenous taxane, oral pentoxifylline

Chemotherapy

Drug

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..

Primary outcomes

  1. The incidence of grade 2 or more peripheral neuropathy in the two groups using Common Terminology Criteria Adverse Event grading

    Time frame: 6 months

    The number of patients reported grade 2 or more peripheral neuropathy in the two groups.

Secondary outcomes

  1. The incidence of grade 2 or more oral mucositis in the two groups using Common Terminology Criteria Adverse Event grading

    Time frame: 6 months

    The number of patients who reported grade 2 or more oral mucositis adverse effects during the treatment period

  2. The incidence of grade 2 or more anemia in the two groups using Common Terminology Criteria Adverse Event grading

    Time frame: 6 months

  3. The incidence of grade 2 or more febrile neutropenia in the two groups using Common Terminology Criteria Adverse Event grading

    Time frame: 6 months

  4. 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

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 2, 2024
Registry last updated
Jul 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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