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NCT Number: NCT06087237

The Efficacy of Using Pentoxifylline 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.

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Key information

Conditions

Post-Surgical Complication Breast Cancer Surgery Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Oncology center of Mansoura University

Al Mansurah, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patients on treatment regimen of phosphodiesterase inhibitors
  • Patients who are taking antiplatelet or anticoagulant treatment
  • Patients who are allergic to phosphodiesterase inhibitors
  • History of recent hemorrhagic events
  • Active peptic ulcer
  • History of psychological problems
  • History of chronic pain management
  • Pregnancy or breastfeeding

Treatment and study plan

Pentoxifylline

Drug

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

paracetamol +ketorolac

Drug

Patients receive the usual treatment only:

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

Primary outcomes

  1. 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).

Secondary outcomes

  1. Numbers of patients need rescue analgesia

    Time frame: 24 hours after surgery

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

  2. Time for wound healing

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

    The time for removal of surgical sutures

  3. 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

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 17, 2023
Registry last updated
Jun 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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