The Efficacy of Using Pentoxifylline in Patients Undergoing Breast Cancer Surgery

June 21, 2025 updated by: Omar Hamdy, Mansoura University

The Efficacy of Pentoxifylline in Reducing Post-surgical Complications in Patients Undergoing Breast Cancer Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

92

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Mansoura, Egypt
        • Oncology Center of Mansoura University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pentoxifylline group
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.
Drug: Pentoxifylline

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.

Other Names:
  • Trental tablets 400mg
Active Comparator: Control group
Patients recieved the standard of care without pentoxifylline.
Drug: paracetamol +ketorolac

Patients receive the usual treatment only:

paracetamol 1g IV every 8 hours and Ketorolac 30 mg IV every 12 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative level of pain
Time Frame: 24 hours after surgery
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).
24 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numbers of patients need rescue analgesia
Time Frame: 24 hours after surgery
The number of patients need rescue analgesia within 24 hours after surgery
24 hours after surgery
Time for wound healing
Time Frame: Within 4 weeks of follow-up after the surgery
The time for removal of surgical sutures
Within 4 weeks of follow-up after the surgery
The incidence of post-surgical complications
Time Frame: Within 4 weeks of follow-up after the surgery
The incidence of seroma, hematoma, surgical site infection, and skin flap necrosis
Within 4 weeks of follow-up after the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Investigators

  • Study Director: Noha O. Mansour, PhD, Clinical Pharmacy and Pharmacy Practice Department, Faculty of Pharmacy, Mansoura University
  • Principal Investigator: Omar H. Abdelaleem, PhD, Faculty pf medicine, Mansoura University
  • Study Chair: Samar A. Dewidar, MSc, Clinical Pharmacy and Pharmacy Practice Department, Faculty of Pharmacy, Mansoura University
  • Study Director: Moetaza M. Soliman, PhD, Clinical Pharmacy and Pharmacy Practice Department, Faculty of Pharmacy, Mansoura University
  • Study Director: Mohamed A. Shams, PhD, Clinical Pharmacy and Pharmacy Practice Department, Faculty of Pharmacy, Mansoura University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 30, 2023

Primary Completion (Actual)

June 30, 2024

Study Completion (Actual)

June 30, 2024

Study Registration Dates

First Submitted

October 11, 2023

First Submitted That Met QC Criteria

October 16, 2023

First Posted (Actual)

October 17, 2023

Study Record Updates

Last Update Posted (Actual)

June 26, 2025

Last Update Submitted That Met QC Criteria

June 21, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-147

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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