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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bromelain + N-Acetylcysteine | Experimental | Patients with pseudomyxoma peritonei that are not candidates to surgical resection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bromelin | Drug | 0.5mg per mL of total tumor volume calculated, administered percutaneously |
|
| 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. |
| 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) |
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Inclusion Criteria:
At least two HIPEC operations or major abdominal surgery (PSS > 3). Patients with acute morbidities (ASA score IV)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lidia Rodríguez Ortiz, MD | Hospital General Universitario Reina Sofía de Murcia | Principal Investigator |
| Álvaro Arjona Sánchez, PhD | Hospital General Universitario Reina Sofía de Murcia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Reina Sofía | Córdoba | 14004 | Spain |
Data will be shared after the study concludes and results are published
After results publication
Upon request to study's principal investigator
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| ID | Term |
|---|---|
| D011553 | Pseudomyxoma Peritonei |
| ID | Term |
|---|---|
| D002288 | Adenocarcinoma, Mucinous |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
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| ID | Term |
|---|---|
| D001963 | Bromelains |
| D000111 | Acetylcysteine |
| ID | Term |
|---|---|
| D003546 | Cysteine Endopeptidases |
| D057056 | Cysteine Proteases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
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Single-arm experimental analytical study
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| N-Acetylcysteine | Drug | 20mg per mL of total tumor volume calculated, administered percutaneously |
|
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. |
| D009370 |
| Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018297 | Neoplasms, Cystic, Mucinous, and Serous |
| D004798 |
| Enzymes |
| D045762 | Enzymes and Coenzymes |
| D010450 | Endopeptidases |
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |