Clinical trial · Interventional
Intratumoral Bromelain + Acetylcysteine in Relapsed and Unresectable Pseudomyxoma Peritonei
Intratumoral Bromelain + N-acetylcysteine in Relapsed and Unresectable Pseudomyxoma Peritonei. Phase I Single-arm Trial
NCT04982146CI-TRIAL-00058880unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pseudomyxoma Peritonei | Pseudomyxoma Peritonei | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bromelin | Drug | — | UNRESOLVED |
| N-Acetylcysteine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Bromelain + N-Acetylcysteine
- description
- Patients with pseudomyxoma peritonei that are not candidates to surgical resection
- interventionNames
- Drug: Bromelin
- Drug: N-Acetylcysteine
Primary outcomes (1)
- measure
- Tumoral Mass Change
- timeFrame
- Day 3, Day 7 (if it applies),1 month and 12 months after treatment is finished.
- description
- Tumoral mass change calculated through CT Scan or Magnetic Resonance categorized regarding the biggest diameter per abdominal region
Secondary outcomes (4)
- measure
- Symptoms improvement
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.