Intratumoral Bromelain + Acetylcysteine in Relapsed and Unresectable Pseudomyxoma Peritonei

NCT04982146 | Unknown Phase 1

• 1 other identifier: BROAC-PMP
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

pseudomyxoma peritonei; n-acetylcysteine; acetylcysteine; NAC; bromelain

Outcome Measures

Primary Outcomes (1)

• Tumoral Mass Change

  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 Outcomes (4)

• Symptoms improvement

  Basal visit, 1 month and 12 months after treatment.

• TTP (Time to tumor progression)

  Period of 12 months after treatment.

• Overall survival

  Period of 12 months after treatment.

• Tumoral DNA diminution in biological samples

  Basal visit, all treatment visits and 12 months after treatment is finished.

Study Arms (1)

Bromelain + N-Acetylcysteine

EXPERIMENTAL

Patients with pseudomyxoma peritonei that are not candidates to surgical resection

Drug: Bromelin; Drug: N-Acetylcysteine

Interventions

Bromelin DRUG

0.5mg per mL of total tumor volume calculated, administered percutaneously

Bromelain + N-Acetylcysteine

N-Acetylcysteine DRUG

20mg per mL of total tumor volume calculated, administered percutaneously

Bromelain + N-Acetylcysteine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maimónides Biomedical Research Institute of Córdoba: lead

Study Sites (1)

Hospital Universitario Reina Sofía

Córdoba, 14004, Spain

Location

MeSH Terms

Conditions

Pseudomyxoma Peritonei

Interventions

Bromelains; Acetylcysteine

Condition Hierarchy (Ancestors)

Adenocarcinoma, Mucinous; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Cystic, Mucinous, and Serous

Intervention Hierarchy (Ancestors)

Cysteine Endopeptidases; Cysteine Proteases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Endopeptidases; Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Lidia Rodríguez Ortiz, MD

  Hospital Universitario Reina Sofía

  PRINCIPAL INVESTIGATOR

• Álvaro Arjona Sánchez, PhD

  Hospital Universitario Reina Sofía

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-arm experimental analytical study

Study Record Dates

• First Submitted: July 6, 2021
• First Posted: July 29, 2021
• Study Start: September 13, 2021
• Primary Completion: May 16, 2022
• Study Completion: May 16, 2023
• Last Updated: June 2, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: After results publication
• Access Criteria: Upon request to study's principal investigator

Locations

ES (1)