Intratumoral Bromelain + Acetylcysteine in Relapsed and Unresectable Pseudomyxoma Peritonei

Pseudomyxoma Peritonei Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04982146
• Other study ID #: BROAC-PMP
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: September 13, 2021
• Est. completion date: May 16, 2023

Study information

• Verified date: June 2022
• Source: Maimónides Biomedical Research Institute of Córdoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: May 16, 2023
• Est. primary completion date: May 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pseudomyxoma Peritonei

Intervention

Drug:
• Bromelin
0.5mg per mL of total tumor volume calculated, administered percutaneously
• N-Acetylcysteine
20mg per mL of total tumor volume calculated, administered percutaneously

Locations

Country	Name	City	State
Spain	Hospital Universitario Reina Sofía	Córdoba

Sponsors (1)

Lead Sponsor	Collaborator
Maimónides Biomedical Research Institute of Córdoba

Country where clinical trial is conducted

Spain, 

Outcome

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