Pseudomyxoma Peritonei
Conditions
Keywords
pseudomyxoma peritonei, n-acetylcysteine, acetylcysteine, NAC, bromelain
Brief 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.
Interventions
DRUGBromelin
0.5mg per mL of total tumor volume calculated, administered percutaneously
DRUGN-Acetylcysteine
20mg per mL of total tumor volume calculated, administered percutaneously
Sponsors
Maimónides Biomedical Research Institute of Córdoba
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single-arm experimental analytical study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tumoral Mass Change | Day 3, Day 7 (if it applies),1 month and 12 months after treatment is finished. | Tumoral mass change calculated through CT Scan or Magnetic Resonance categorized regarding the biggest diameter per abdominal region |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Symptoms improvement | Basal visit, 1 month and 12 months after treatment. | Symptoms progression evaluated through QLQ-C30 questionnaire (life quality questionnaire) |
| TTP (Time to tumor progression) | Period of 12 months after treatment. | Period of time free of tumor progression. |
| Overall survival | Period of 12 months after treatment. | Time until death from any cause |
| Tumoral DNA diminution in biological samples | Basal visit, all treatment visits and 12 months after treatment is finished. | Diminution of tumoral DNA amount found in mucin and blood samples |
Countries
Spain
Outcome results
None listed