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

Breast Cancer Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06186700
• Other study ID #: 2023-147-2
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: December 25, 2023
• Est. completion date: April 5, 2024

Study information

• Verified date: March 2024
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: April 5, 2024
• Est. primary completion date: April 5, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer Female
• Breast Neoplasms
• Mucositis

Intervention

Drug:
• Pentoxifylline
Pentoxiphylline tablets three times per day for the treatment period of neoadjuvant chemotherapy cycles of doxorubicin/ cyclophosphamide
• Placebo
Placebo tablets three times per day for the treatment period of neoadjuvant chemotherapy cycles of doxorubicin/ cyclophosphamide

Locations

Country	Name	City	State
Egypt	Oncology Center of Mansoura University	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of mucositis in the two groups using WHO grading of oral mucositis	The number of patients reported oral mucositis in the two groups.	3 months
Secondary	Severity of doxorubicin/cyclophosphamide induced mucositis using the VAS visual analogue scale.	The level of pain will be assessed using the visual analogue scale after each cycle.The score starts with 0, indicating the lowest level of pain and ends with 10, indicating the highest level of pain	3 months
Secondary	Assessment of the patient's QoL life using an EQ-5D-3L questionnaire	Measures quality of life related to signs and symptoms of chemotherapy-induced oral mucositis	3 months
Secondary	The Functional Oral Intake Scale (FOIS) to assess the patient's ability to swallow food and liquids	Measures the ability of the patient to swallow food and liquids	3 months
Secondary	The incidence of adverse effects	The number of patients who reported adverse effects during the treatment period will be reported	3 months