Intratumoral Bromelain + Acetylcysteine in Relapsed and Unresectable Pseudomyxoma Peritonei

June 1, 2022 updated by: Maimónides Biomedical Research Institute of Córdoba

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Córdoba, Spain, 14004
        • Hospital Universitario Reina Sofia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bromelain + N-Acetylcysteine
Patients with pseudomyxoma peritonei that are not candidates to surgical resection
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumoral Mass Change
Time Frame: Day 3, Day 7 (if it applies),1 month and 12 months after treatment is finished.
Tumoral mass change calculated through CT Scan or Magnetic Resonance categorized regarding the biggest diameter per abdominal region
Day 3, Day 7 (if it applies),1 month and 12 months after treatment is finished.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptoms improvement
Time Frame: Basal visit, 1 month and 12 months after treatment.
Symptoms progression evaluated through QLQ-C30 questionnaire (life quality questionnaire)
Basal visit, 1 month and 12 months after treatment.
TTP (Time to tumor progression)
Time Frame: Period of 12 months after treatment.
Period of time free of tumor progression.
Period of 12 months after treatment.
Overall survival
Time Frame: Period of 12 months after treatment.
Time until death from any cause
Period of 12 months after treatment.
Tumoral DNA diminution in biological samples
Time Frame: Basal visit, all treatment visits and 12 months after treatment is finished.
Diminution of tumoral DNA amount found in mucin and blood samples
Basal visit, all treatment visits and 12 months after treatment is finished.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maimónides Biomedical Research Institute of Córdoba

Investigators

  • Principal Investigator: Lidia Rodríguez Ortiz, MD, Hospital Universitario Reina Sofia
  • Principal Investigator: Álvaro Arjona Sánchez, PhD, Hospital Universitario Reina Sofia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 13, 2021

Primary Completion (Actual)

May 16, 2022

Study Completion (Anticipated)

May 16, 2023

Study Registration Dates

First Submitted

July 6, 2021

First Submitted That Met QC Criteria

July 19, 2021

First Posted (Actual)

July 29, 2021

Study Record Updates

Last Update Posted (Actual)

June 2, 2022

Last Update Submitted That Met QC Criteria

June 1, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BROAC-PMP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Data will be shared after the study concludes and results are published

IPD Sharing Time Frame

After results publication

IPD Sharing Access Criteria

Upon request to study's principal investigator

IPD Sharing Supporting Information Type

  • Study Protocol
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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