The Efficacy of Using Pentoxifylline in Patients Undergoing Breast Cancer Surgery

Phase 2

Recruiting

• Conditions: Post-Surgical Complication; Breast Cancer Surgery
• Interventions: Drug: Placebo; Drug: Pentoxifylline

• Registration Number: NCT06087237
• Lead Sponsor: Mansoura University

Brief Summary

The goal of this clinical trial is to assess the efficacy of pentoxifylline in reducing post surgical complications for breast cancer patients undergoing breast cancer surgery. It aims to evaluate the efficacy of pentoxifylline on postoperative pain and wound healing.

Participants will take oral pentoxifylline then post surgical oral pentoxifylline three times per day for 2 weeks. The researchers will compare the difference in pain score and wound healing relative to the control group.

Detailed Description

The goal of this clinical trial is to assess the efficacy of pentoxifylline in reducing post surgical 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 oral oral pentoxifylline 400 mg three times per day 400 mg three times for the day before surgery then oral pentoxifylline 400 mg three times per day for 2 weeks while the control group will take placebo tablet one day before surgey and placebo tablets three times per day for 2 weeks after surgery. the researchers will compare the difference in pain score and time for wound healing relatively to the control group.

Study Timeline

• Study First Submitted: 2023-10-11
• Study First Submitted QC: 2023-10-16
• Study First Posted: 2023-10-17
• Study Start: 2023-10-30
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-03
• Last Update Posted: 2023-12-08
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Placebo	oral placebo tablets three times per day starting the day before the surgery till 2 weeks after surgery
Pentoxifylline group	Pentoxifylline	oral Pentoxifylline 400 mg three times per day starting the day before the surgery till 2 weeks after surgery

Primary Outcome Measures

Name	Time	Method
Postoperative level of pain	24 hours after surgery	Postoperative level of pain immediately after the surgery and every 6 hours until 24 hours after surgery using the Visual Analogue Score (VAS) ranging from 0 (indicating no pain) to 10 (expressing the pain as bad as it could possibly be).

Secondary Outcome Measures

Name	Time	Method
Numbers of patients need rescue analgesia	24 hours after surgery	The number of patients need rescue analgesia within 24 hours after surgery
Time (hours) to first request analgesia	within 24 hours after surgery	The first time after surgery at which the patient needs analgesia.
Time for wound healing	Within 2-3 weeks of follow-up after the surgery	The time for removal of surgical sutures
The incidence of post-surgical complications	Within 2-3 weeks of follow-up after the surgery	The incidence of seroma, hematoma, surgical site infection, and skin flap necrosis

Trial Locations

Locations (1)

Oncology center of Mansoura University; 🇪🇬 Mansoura, Egypt