Intratumoral Bromelain + Acetylcysteine in Relapsed and Unresectable Pseudomyxoma Peritonei

Phase 1

• Conditions: Pseudomyxoma Peritonei
• Interventions: Drug: Bromelin; Drug: N-Acetylcysteine

• Registration Number: NCT04982146
• Lead Sponsor: Maimónides Biomedical Research Institute of Córdoba

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-06
• Study First Submitted QC: 2021-07-19
• Study First Posted: 2021-07-29
• Study Start: 2021-09-13
• Primary Completion: 2022-05-16
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-01
• Last Update Posted: 2022-06-02
• Study Completion: 2023-05-16

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bromelain + N-Acetylcysteine	N-Acetylcysteine	Patients with pseudomyxoma peritonei that are not candidates to surgical resection
Bromelain + N-Acetylcysteine	Bromelin	Patients with pseudomyxoma peritonei that are not candidates to surgical resection

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Symptoms improvement	Basal visit, 1 month and 12 months after treatment.	Symptoms progression evaluated through QLQ-C30 questionnaire (life quality questionnaire)
TTP (Time to tumor progression)	Period of 12 months after treatment.	Period of time free of tumor progression.
Overall survival	Period of 12 months after treatment.	Time until death from any cause
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

Trial Locations

Locations (1)

Hospital Universitario Reina Sofía; 🇪🇸 Córdoba, Spain