Intratumoral Bromelain + Acetylcysteine in Relapsed and Unresectable Pseudomyxoma Peritonei

Study Overview
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Brief Summary
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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.

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

Conditions
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Pseudomyxoma Peritonei

Intervention / Treatment
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* Drug: Bromelin
* Drug: N-Acetylcysteine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single-arm experimental analytical study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bromelain + N-Acetylcysteine<br>Patients with pseudomyxoma peritonei that are not candidates to surgical resection | Drug: Bromelin<br>* 0.5mg per mL of total tumor volume calculated, administered percutaneously<br>Drug: N-Acetylcysteine<br>* 20mg per mL of total tumor volume calculated, administered percutaneously<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pseudomyxoma peritonei, n-acetylcysteine, acetylcysteine, NAC, bromelain