The Efficacy of Using Pentoxifylline in Patients Undergoing Breast Cancer Surgery

NCT06087237 | Completed Phase 2 DMC

• 1 other identifier: 2023-147
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post-Surgical Complication; Breast Cancer Surgery

Keywords

pain; wound healing; post-surgery; breast cancer

Outcome Measures

Primary Outcomes (1)

• 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).

  24 hours after surgery

Secondary Outcomes (3)

• Numbers of patients need rescue analgesia

  24 hours after surgery

• Time for wound healing

  Within 4 weeks of follow-up after the surgery

• The incidence of post-surgical complications

  Within 4 weeks of follow-up after the surgery

Study Arms (2)

Pentoxifylline group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

Patients recieved the standard of care without pentoxifylline.

Drug: paracetamol +ketorolac

Interventions

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.

Also known as: Trental tablets 400mg

Pentoxifylline group

paracetamol +ketorolac DRUG

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

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Oncology center of Mansoura University

Al Mansurah, Egypt

Location

Related Publications (1)

• Dewidar SA, Mansour NO, Hamdy O, Elebedy DA, Soliman MM, Shams MEE. Efficacy of using pentoxifylline in patients undergoing breast cancer surgery. Front Pharmacol. 2025 Jul 16;16:1560805. doi: 10.3389/fphar.2025.1560805. eCollection 2025.

  PMID: 40741002 DERIVED

MeSH Terms

Conditions

Pain; Breast Neoplasms

Interventions

Pentoxifylline

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Theobromine; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Samar A. Dewidar, MSc

  clinical pharmacy and pharmacy practice department, Faculty of pharmacy, Mansoura University

  STUDY CHAIR

• Noha O. Mansour, PhD

  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 DIRECTOR

• Omar H. Abdelaleem, PhD

  Faculty pf medicine, Mansoura University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: October 11, 2023
• First Posted: October 17, 2023
• Study Start: October 30, 2023
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: June 26, 2025

Record last verified: 2025-06

Locations

EG (1)