The Efficacy of Using Pentoxifylline in Patients Undergoing Breast Cancer Surgery

Mansoura University

Status and phase: Completed; Phase 2

Conditions: Breast Cancer Surgery; Post-Surgical Complication

Treatments: Drug: paracetamol +ketorolac; Drug: Pentoxifylline

Study type: Interventional

Funder types: Other

Identifiers

NCT06087237

2023-147

Details and patient eligibility

About

The goal of this clinical trial is to assess the efficacy of pentoxifylline in reducing postsurgical complications for breast cancer patients undergoing breast cancer surgery. It aims to evaluate the efficacy of pentoxifylline on postoperative pain and wound healing.

Full description

The goal of this clinical trial is to assess the efficacy of pentoxifylline in reducing postsurgical complications for breast cancer patients undergoing mastectomy.

It aims to evaluate the efficacy of adjuvant pentoxifylline in reducing postoperative pain and improving wound healing in breast cancer patients undergoing mastectomy surgery.

Participants will take standard of care treatment with oral pentoxifylline 400 mg 2 hours before surgery, then oral pentoxifylline 400 mg three times per day for 4 weeks, while the control group will only take standard of care. The researchers will compare the difference in pain score and time for wound healing relative to the control group.

Enrollment: 92 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adult female patients aged 18 to 65 years
2. Patients completed neoadjuvant chemotherapy cycles and scheduled for breast cancer surgery.

Exclusion criteria

1. Patients on 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. History of psychological problems
7. History of chronic pain management
8. Pregnancy or breastfeeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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92 participants in 2 patient groups

Pentoxifylline group

Experimental group

Description:

Two 400 mg extended-release pentoxifylline oral tablets are administered 2 hours before surgery, then one tablet three times per day after surgery, and continue for four weeks after the surgery. Standard of care for pain management, including paracetamol 1g IV every 8 hours and Ketorolac 30 mg IV every 12 hours.

Treatment:

Drug: Pentoxifylline

Control group

Active Comparator group

Description:

Patients recieved the standard of care without pentoxifylline.

Treatment:

Drug: paracetamol +ketorolac