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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

About this trial

This is an interventional treatment trial for Pseudomyxoma Peritonei focused on measuring pseudomyxoma peritonei, n-acetylcysteine, acetylcysteine, NAC, bromelain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Studies a U.S. FDA-regulated Device Product

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

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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