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

NCT06186700 | Completed Phase 2

• 1 other identifier: 2023-147-2
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

neoadjuvant chemotherapy, pentoxiphyllin, doxorubicin, cyclophosphamide, mucositis, quality of life

Outcome Measures

Primary Outcomes (1)

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

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

  6 months

Secondary Outcomes (4)

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

  6 months

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

  6 months

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

  6 months

• 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

  6 months

Study Arms (2)

Pentoxifylline group

ACTIVE COMPARATOR

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: Pentoxifylline 400mg plus chemotherapy

Control group

OTHER

The patient will take standard neoadjuvant chemotherapy, including doxorubicin/cyclophosphamide, followed by a taxane regimen as per the medical committee.

Drug: Chemotherapy

Interventions

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.

Also known as: Intravenous doxorubicin, Intravenous cyclophosphamide, Intravenous taxane, oral pentoxifylline

Pentoxifylline group

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..

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Oncology Center of Mansoura University

Al Mansurah, Egypt

Location

Related Publications (1)

• Dewidar SA, Mansour NO, Hamdy O, Eltantawy A, Soliman MM, Shams MEE. Assessing the efficacy and safety of pentoxifylline in preventing chemotherapy-induced peripheral neuropathy and mucositis in breast cancer patients. Front Pharmacol. 2025 Oct 14;16:1678161. doi: 10.3389/fphar.2025.1678161. eCollection 2025.

  PMID: 41164763 DERIVED

MeSH Terms

Conditions

Mucositis

Interventions

Pentoxifylline; Drug Therapy

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Theobromine; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 16, 2023
• First Posted: January 2, 2024
• Study Start: December 25, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: July 28, 2025

Record last verified: 2025-02

Locations

EG (1)