Intratumoral Bromelain + Acetylcysteine in Relapsed and Unresectable Pseudomyxoma Peritonei

Maimónides Biomedical Research Institute of Córdoba

Status and phase

Active, not recruiting

Phase 1

Conditions

Pseudomyxoma Peritonei

Treatments

Drug: N-Acetylcysteine

Drug: Bromelin

Study type

Interventional

Funder types

Other

Identifiers

NCT04982146

BROAC-PMP

Details and patient eligibility

About

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.

Enrollment

10 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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