Intratumoral Bromelain + Acetylcysteine in Relapsed and Unresectable Pseudomyxoma Peritonei

• Status: Recruiting
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This trial pursues studying a compassionate treatment option for patients with inoperable pseudomyxoma peritonei through percutaneous administration of bromelain + N-acetylcysteine (NAC) in order to decrease tumoral volume. Secondary endpoints are the decrease of ascites, compressive symptoms and pain through the dilution of mucins, which would better intestinal blockage.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Maimónides Biomedical Research Institute of Córdoba
• Treatments: Acetylcysteine; N-monoacetylcystine

Criteria

Inclusion Criteria:

• Pseudomyxoma peritonei diagnosis through imaging tests and/or histological studies

• Pseudomyxoma peritonei relapse in abdominal area in patients who comply inoperability criteria, which are:

At least two HIPEC operations or major abdominal surgery (PSS > 3). Patients with acute morbidities (ASA score IV)

• ECOG 0-2

• Age ≥ 18

• Signs informed consent

Exclusion Criteria:

• Candidates to other potentially healing treatments

• Allergy to bromelains (pineapple), N-Acetylcysteine or possible cross-reactive allergy (eggs, sulphate. latex, carrots, celery, wheat...)

• Non-manageable coagulation alterations

• No possibility of intraabdominal drainage catheter

• Acute respiratory pathology (asthma, COPD), acute hepatic, cardiopathic or kidney pathology

• Allergy to any substance that might cause crossed reactivity to bromelain

• Unwillingness to participate in this clinical trial