NCT04982146

Intratumoral Bromelain + Acetylcysteine in Relapsed and Unresectable Pseudomyxoma Peritonei

Intratumoral Bromelain + N-acetylcysteine in Relapsed and Unresectable Pseudomyxoma Peritonei. Phase I Single-arm Trial

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Maimónides Biomedical Research Institute of Córdoba · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pseudomyxoma Peritonei

Interventions

Type	Name	Description
DRUG	Bromelin	0.5mg per mL of total tumor volume calculated, administered percutaneously
DRUG	N-Acetylcysteine	20mg per mL of total tumor volume calculated, administered percutaneously

Timeline

• Start date: 2021-09-13
• Primary completion: 2022-05-16
• Completion: 2023-05-16
• First posted: 2021-07-29
• Last updated: 2022-06-02

Locations

1 site across 1 country: Spain