Clinical trial

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

Name

2023-147-2

Description

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.

Trial arms

Trial start

2023-12-25

Estimated PCD

2024-04-05

Trial end

2024-04-05

Status

Active (not recruiting)

Phase

Early phase I

Treatment

Pentoxifylline

Pentoxiphylline tablets three times per day for the treatment period of neoadjuvant chemotherapy cycles of doxorubicin/ cyclophosphamide

Arms:

Pentoxifylline group

Other names:

Intravenous doxorubicin, Intravenous cyclophosphamide

Placebo

Placebo tablets three times per day for the treatment period of neoadjuvant chemotherapy cycles of doxorubicin/ cyclophosphamide

Arms:

Control group

Other names:

Intravenous doxorubicin, Intravenous cyclophosphamide

Size

Primary endpoint

The incidence of mucositis in the two groups using WHO grading of oral mucositis

3 months

Eligibility 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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 80, 'type': 'ESTIMATED'}}

Updated at

2024-03-15

1 organization

1 product

1 drug

1 indication

Organization

Product

Indication

Drug