The Efficacy of Using Pentoxifylline in Patients Undergoing Breast Cancer Surgery

NCT ID: NCT06087237

Last Updated: 2025-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-30

Study Completion Date

2024-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Post-Surgical Complication Breast Cancer Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Pentoxifylline

Intervention Type 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.

Control group

Patients recieved the standard of care without pentoxifylline.

Group Type ACTIVE_COMPARATOR

paracetamol +ketorolac

Intervention Type DRUG

Patients receive the usual treatment only:

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

Interventions

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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.

Intervention Type DRUG

paracetamol +ketorolac

Patients receive the usual treatment only:

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

Intervention Type DRUG

Other Intervention Names

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Trental tablets 400mg

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Omar Hamdy

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Samar A. Dewidar, MSc

Role: STUDY_CHAIR

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

Noha O. Mansour, PhD

Role: STUDY_DIRECTOR

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

Moetaza M. Soliman, PhD

Role: STUDY_DIRECTOR

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

Mohamed A. Shams, PhD

Role: STUDY_DIRECTOR

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

Omar H. Abdelaleem, PhD

Role: PRINCIPAL_INVESTIGATOR

Faculty pf medicine, Mansoura University

Locations

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Oncology center of Mansoura University

Al Mansurah, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type DERIVED
PMID: 40741002 (View on PubMed)

Other Identifiers

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2023-147

Identifier Type: -

Identifier Source: org_study_id

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