A Phase 1 interventional study of Bromelin and N-Acetylcysteine in Pseudomyxoma Peritonei, sponsored by Maimónides Biomedical Research Institute of Córdoba. Status unknown at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-06-02.
Sponsored by Maimónides Biomedical Research Institute of Córdoba · Phase 1, Interventional, and Treatment
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.
35 studies on the registry are indexed under Pseudomyxoma Peritonei; 14 are open to participants now.
This study's planned enrollment of 10 is below the median of 38 across 25 interventional studies indexed under Pseudomyxoma Peritonei.
Browse Pseudomyxoma Peritonei studies →Maimónides Biomedical Research Institute of Córdoba is the lead sponsor of 78 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
At least two HIPEC operations or major abdominal surgery (PSS > 3). Patients with acute morbidities (ASA score IV)
Exclusion Criteria:
Patients with pseudomyxoma peritonei that are not candidates to surgical resection
Drug: Bromelin · Drug: N-Acetylcysteine
0.5mg per mL of total tumor volume calculated, administered percutaneously
20mg per mL of total tumor volume calculated, administered percutaneously
Tumoral Mass Change
Tumoral mass change calculated through CT Scan or Magnetic Resonance categorized regarding the biggest diameter per abdominal region
Time frame: Day 3, Day 7 (if it applies),1 month and 12 months after treatment is finished.
Symptoms improvement
Symptoms progression evaluated through QLQ-C30 questionnaire (life quality questionnaire)
Time frame: Basal visit, 1 month and 12 months after treatment.
TTP (Time to tumor progression)
Period of time free of tumor progression.
Time frame: Period of 12 months after treatment.
Overall survival
Time until death from any cause
Time frame: Period of 12 months after treatment.
Tumoral DNA diminution in biological samples
Diminution of tumoral DNA amount found in mucin and blood samples
Time frame: Basal visit, all treatment visits and 12 months after treatment is finished.
Plan to share: Yes — Data will be shared after the study concludes and results are published
Supporting information: Study protocol, Icf, Csr
No publications or documents are linked to this record.
This study is status unknown, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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Maimónides Biomedical Research Institute of Córdoba