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 range18 Years

SexALL

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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

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

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