Intratumoral Bromelain + Acetylcysteine in Relapsed and Unresectable Pseudomyxoma Peritonei
Primary Purpose
Pseudomyxoma Peritonei
Status
Active
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
Bromelin
N-Acetylcysteine
Sponsored by
About this trial
This is an interventional treatment trial for Pseudomyxoma Peritonei focused on measuring pseudomyxoma peritonei, n-acetylcysteine, acetylcysteine, NAC, bromelain
Eligibility Criteria
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
Sites / Locations
- Hospital Universitario Reina Sofía
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Bromelain + N-Acetylcysteine
Arm Description
Patients with pseudomyxoma peritonei that are not candidates to surgical resection
Outcomes
Primary Outcome Measures
Tumoral Mass Change
Tumoral mass change calculated through CT Scan or Magnetic Resonance categorized regarding the biggest diameter per abdominal region
Secondary Outcome Measures
Symptoms improvement
Symptoms progression evaluated through QLQ-C30 questionnaire (life quality questionnaire)
TTP (Time to tumor progression)
Period of time free of tumor progression.
Overall survival
Time until death from any cause
Tumoral DNA diminution in biological samples
Diminution of tumoral DNA amount found in mucin and blood samples
Full Information
NCT ID
NCT04982146
First Posted
July 6, 2021
Last Updated
June 1, 2022
Sponsor
Maimónides Biomedical Research Institute of Córdoba
1. Study Identification
Unique Protocol Identification Number
NCT04982146
Brief Title
Intratumoral Bromelain + Acetylcysteine in Relapsed and Unresectable Pseudomyxoma Peritonei
Official Title
Intratumoral Bromelain + N-acetylcysteine in Relapsed and Unresectable Pseudomyxoma Peritonei. Phase I Single-arm Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 13, 2021 (Actual)
Primary Completion Date
May 16, 2022 (Actual)
Study Completion Date
May 16, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maimónides Biomedical Research Institute of Córdoba
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pseudomyxoma Peritonei
Keywords
pseudomyxoma peritonei, n-acetylcysteine, acetylcysteine, NAC, bromelain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Single-arm experimental analytical study
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bromelain + N-Acetylcysteine
Arm Type
Experimental
Arm Description
Patients with pseudomyxoma peritonei that are not candidates to surgical resection
Intervention Type
Drug
Intervention Name(s)
Bromelin
Intervention Description
0.5mg per mL of total tumor volume calculated, administered percutaneously
Intervention Type
Drug
Intervention Name(s)
N-Acetylcysteine
Intervention Description
20mg per mL of total tumor volume calculated, administered percutaneously
Primary Outcome Measure Information:
Title
Tumoral Mass Change
Description
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.
Secondary Outcome Measure Information:
Title
Symptoms improvement
Description
Symptoms progression evaluated through QLQ-C30 questionnaire (life quality questionnaire)
Time Frame
Basal visit, 1 month and 12 months after treatment.
Title
TTP (Time to tumor progression)
Description
Period of time free of tumor progression.
Time Frame
Period of 12 months after treatment.
Title
Overall survival
Description
Time until death from any cause
Time Frame
Period of 12 months after treatment.
Title
Tumoral DNA diminution in biological samples
Description
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lidia Rodríguez Ortiz, MD
Organizational Affiliation
Hospital Universitario Reina Sofía
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Álvaro Arjona Sánchez, PhD
Organizational Affiliation
Hospital Universitario Reina Sofía
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario Reina Sofía
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be shared after the study concludes and results are published
IPD Sharing Time Frame
After results publication
IPD Sharing Access Criteria
Upon request to study's principal investigator
Learn more about this trial
Intratumoral Bromelain + Acetylcysteine in Relapsed and Unresectable Pseudomyxoma Peritonei
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