Clinical trial NCT06087237: The Efficacy of Using Pentoxifylline in Patients Undergoing Breast Cancer Surgery
Official title: The Efficacy of Pentoxifylline in Reducing Post-surgical Complications in Patients Undergoing Breast Cancer Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Post-Surgical Complication
Breast Cancer Surgery
Keywords: pain
wound healing
post-surgery
breast cancer
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2023-10-17
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative level of pain
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: Numbers of patients need rescue analgesia
timeFrame: 24 hours after surgery
measure: Time (hours) to first request analgesia
timeFrame: within 24 hours after surgery
measure: Time for wound healing
timeFrame: Within 2-3 weeks of follow-up after the surgery
measure: The incidence of post-surgical complications
timeFrame: Within 2-3 weeks of follow-up after the surgery
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Oncology center of Mansoura University
Study officials:
affiliation: clinical pharmacy and pharmacy practice department, Faculty of pharmacy, Mansoura University
name: Samar A. Dewidar, MSc
role: STUDY_CHAIR
affiliation: Clinical pharmacy and pharmacy practice department, Faculty of pharmacy, Mansoura University
name: Noha O. Mansour, PhD
role: STUDY_DIRECTOR
affiliation: Clinical pharmacy and pharmacy practice department, Faculty of pharmacy, Mansoura University
name: Moetaza M. Soliman, PhD
role: STUDY_DIRECTOR
affiliation: Clinical pharmacy and pharmacy practice department, Faculty of pharmacy, Mansoura University
name: Mohamed A. Shams, PhD
role: STUDY_DIRECTOR
affiliation: Faculty pf medicine, Mansoura University
name: Omar H. Abdelaleem, PhD
role: PRINCIPAL_INVESTIGATOR
References: