The Efficacy of Using Pentoxifylline in Patients Undergoing Breast Cancer Surgery

Mansoura University92 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Post-Surgical Complication Breast Cancer Surgery

Interventions

PentoxifyllineDRUG

Two 400 mg extended-release pentoxifylline oral tablets are administered 2 hours before surgery, then one tablet three times per day after surgery, and continued 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.

paracetamol +ketorolacDRUG

Patients receive the usual treatment only: paracetamol 1g IV every 8 hours and Ketorolac 30 mg IV every 12 hours

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Oncology center of Mansoura University

Al Mansurah, Egypt

Outcomes

Primary Outcomes

Postoperative level of pain

Postoperative level of pain immediately after the surgery and every 6 hours until 24 hours after surgery using the Numeric Rating Score (NRS) ranging from 0 (indicating no pain) to 10 (expressing the pain as bad as it could possibly be).

Time frame: 24 hours after surgery

Secondary Outcomes

Numbers of patients need rescue analgesia

The number of patients need rescue analgesia within 24 hours after surgery

Time frame: 24 hours after surgery

Time for wound healing

The time for removal of surgical sutures

Time frame: Within 4 weeks of follow-up after the surgery

The incidence of post-surgical complications

The incidence of seroma, hematoma, surgical site infection, and skin flap necrosis

Time frame: Within 4 weeks of follow-up after the surgery

Data from ClinicalTrials.gov

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