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

• Status: Active, not recruiting
• Trial end date: 2024-04-05
• Target enrollment: 0
• Participant gender: Female

Summary

This clinical trial is a randomized controlled trial that aims to assess the usefulness of adding pentoxifylline to the neoadjuvant chemotherapy treatment protocol of doxorubicin/cyclophosphamide for breast cancer patients to decrease the incidence of developing oral mucositis, downgrade the mucositis symptoms, alleviate the associated pain using the visual analogue scale, 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 fourth cycle. The researchers will compare the mucositis incidence and grade in the presence or absence of oral pentoxifylline.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mansoura University
• Treatments: Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Pentoxifylline

Criteria

Inclusion Criteria:

1. Adult female patients >18 years old with histologic confirmation of invasive breast cancer

2. Planned to administer neoadjuvant chemotherapy protocol comprised of doxorubicin/ cyclophosphamide followed by paclitaxel (AC/T)

3. Adequate hepatic, renal, and bone marrow functions

Exclusion Criteria:

1. Patients on a treatment regimen of phosphodiesterase inhibitors

2. Patients who are taking antiplatelet or anticoagulant treatment

3. Patients who are allergic to phosphodiesterase inhibitors

4. History of recent hemorrhagic events

5. Active peptic ulcer

6. patients who have mouth or teeth problem.