The Efficacy of Using Pentoxifylline in Patients Undergoing Breast Cancer Surgery

Breast Cancer Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06087237
• Other study ID #: 2023-147
• Status: Recruiting
• Phase: Phase 2
• Start date: October 30, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: December 2023
• Source: Mansoura University
• Contact: Samar A. Dewidar, MSc
• Phone: +201558333468
• Email: s.dewidar[@]mans.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer Surgery
• Breast Neoplasms

Intervention

Drug:
• Pentoxifylline
400 mg pentoxifylline oral tablets three times per day starting from the day before surgery till two weeks after the surgery.
• Placebo
placebo tablets three times per day starting from the day before surgery till two weeks after the surgery.

Locations

Country	Name	City	State
Egypt	Oncology center of Mansoura University	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative level of pain	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).	24 hours after surgery
Secondary	Numbers of patients need rescue analgesia	The number of patients need rescue analgesia within 24 hours after surgery	24 hours after surgery
Secondary	Time (hours) to first request analgesia	The first time after surgery at which the patient needs analgesia.	within 24 hours after surgery
Secondary	Time for wound healing	The time for removal of surgical sutures	Within 2-3 weeks of follow-up after the surgery
Secondary	The incidence of post-surgical complications	The incidence of seroma, hematoma, surgical site infection, and skin flap necrosis	Within 2-3 weeks of follow-up after the surgery