UnknownPhase 1

Intratumoral Bromelain + Acetylcysteine in Relapsed and Unresectable Pseudomyxoma Peritonei

Spain10 participantsStarted 2021-09-13

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Tumoral Mass Change

Timeframe: Day 3, Day 7 (if it applies),1 month and 12 months after treatment is finished.

Trial details

NCT IDNCT04982146

SponsorMaimónides Biomedical Research Institute of Córdoba

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-05-16

View on ClinicalTrials.gov More Pseudomyxoma Peritonei trials