Intratumoral Bromelain + Acetylcysteine in Relapsed and Unresectable Pseudomyxoma Peritonei

• Sponsor: Maimónides Biomedical Research Institute of Córdoba (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04982146
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 20
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pseudomyxoma Peritonei	Drug: Bromelin; Drug: N-Acetylcysteine	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Single-arm experimental analytical studySingle-arm experimental analytical study
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Intratumoral Bromelain + N-acetylcysteine in Relapsed and Unresectable Pseudomyxoma Peritonei. Phase I Single-arm Trial
• Actual Study Start Date: Sep 13, 2021
• Actual Primary Completion Date: May 16, 2022
• Anticipated Study Completion Date: May 16, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Tumoral Mass Change [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

Secondary Outcome Measures

1. Symptoms improvement [Basal visit, 1 month and 12 months after treatment.]

   Symptoms progression evaluated through QLQ-C30 questionnaire (life quality questionnaire)

2. TTP (Time to tumor progression) [Period of 12 months after treatment.]

   Period of time free of tumor progression.

3. Overall survival [Period of 12 months after treatment.]

   Time until death from any cause

4. Tumoral DNA diminution in biological samples [Basal visit, all treatment visits and 12 months after treatment is finished.]

   Diminution of tumoral DNA amount found in mucin and blood samples

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Universitario Reina Sofía	Córdoba		Spain	14004

Sponsors and Collaborators

• Maimónides Biomedical Research Institute of Córdoba

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Maimónides Biomedical Research Institute of Córdoba
• ClinicalTrials.gov Identifier: NCT04982146
• Other Study ID Numbers: BROAC-PMP
• First Posted: Jul 29, 2021
• Last Update Posted: Jun 2, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Maimónides Biomedical Research Institute of Córdoba: pseudomyxoma peritonei; n-acetylcysteine; acetylcysteine; NAC; bromelain
• Additional relevant MeSH terms: Pseudomyxoma Peritonei; Acetylcysteine; N-monoacetylcystine

Study Results

No Results Posted as of Jun 2, 2022