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Intratumoral Bromelain + Acetylcysteine in Relapsed and Unresectable Pseudomyxoma Peritonei

NCT04982146 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2022-06-02

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Maimónides Biomedical Research Institute of Córdoba

    lead OTHER

Principal Investigators

  • Lidia Rodríguez Ortiz, MD · Hospital Universitario Reina Sofía

  • Álvaro Arjona Sánchez, PhD · Hospital Universitario Reina Sofía

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-13
Primary Completion
2022-05-16
Completion
2023-05-16

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04982146 on ClinicalTrials.gov