Pseudomyxoma PeritoneiPhase 1NCT04982146
Intratumoral Bromelain + Acetylcysteine in Relapsed and Unresectable Pseudomyxoma Peritonei
A Phase 1 study testing Bromelin and N-Acetylcysteine in people with Pseudomyxoma Peritonei, run by Maimónides Biomedical Research Institute of Córdoba at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pseudomyxoma Peritonei
- What is being tested?
- Bromelin and N-Acetylcysteine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSpain
- Study dates
- 13 Sep 2021to 16 May 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intratumoral Bromelain + N-acetylcysteine in Relapsed and Unresectable Pseudomyxoma Peritonei. Phase I Single-arm Trial
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.
- Conditions
- Pseudomyxoma Peritonei
- Being tested
- Bromelin, N-Acetylcysteine
- Keywords
- pseudomyxoma peritonei, n-acetylcysteine, acetylcysteine, NAC, bromelain
- Medical subject headings
- Pseudomyxoma Peritonei
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BromelinDrug
0.5mg per mL of total tumor volume calculated, administered percutaneously
N-AcetylcysteineDrug
20mg per mL of total tumor volume calculated, administered percutaneously
| Study group | Role | What they receive |
|---|---|---|
| Bromelain + N-Acetylcysteine | Experimental | Patients with pseudomyxoma peritonei that are not candidates to surgical resection Receives: Drug: Bromelin; Drug: N-Acetylcysteine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumoral Mass Change
Tumoral mass change calculated through CT Scan or Magnetic Resonance categorized regarding the biggest diameter per abdominal region
Measured: Day 3, Day 7 (if it applies),1 month and 12 months after treatment is finished.
Secondary outcomes (4)
Symptoms improvement
Symptoms progression evaluated through QLQ-C30 questionnaire (life quality questionnaire)
Measured: Basal visit, 1 month and 12 months after treatment.
TTP (Time to tumor progression)
Period of time free of tumor progression.
Measured: Period of 12 months after treatment.
Overall survival
Time until death from any cause
Measured: Period of 12 months after treatment.
Tumoral DNA diminution in biological samples
Diminution of tumoral DNA amount found in mucin and blood samples
Measured: Basal visit, all treatment visits and 12 months after treatment is finished.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2021
- Study start13 Sep 2021
- Primary completion16 May 2022
- Study completion16 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pseudomyxoma PeritoneiStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm experimental analytical study
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maimónides Biomedical Research Institute of Córdoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lidia Rodríguez Ortiz, MD, Principal investigator, Hospital General Universitario Reina Sofía de MurciaÁlvaro Arjona Sánchez, PhD, Principal investigator, Hospital General Universitario Reina Sofía de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04982146
- Sponsor's protocol ID
- BROAC-PMP
- Status last verified
- Jun 2022
- First submitted
- 6 Jul 2021
- Last updated
- 2 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared after the study concludes and results are published
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intratumoral Bromelain + N-acetylcysteine in Relapsed and Unresectable Pseudomyxoma Peritonei. Phase I Single-arm Trial
- ClinicalTrials.gov ID
- NCT04982146
- Acronym / sponsor ID
- BROAC-PMP
- Conditions
- Pseudomyxoma Peritonei
- Keywords
- pseudomyxoma peritonei, n-acetylcysteine, acetylcysteine, NAC, bromelain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Maimónides Biomedical Research Institute of CórdobaUniversity, hospital or other
- Study start
- 13 Sep 2021 (actual)
- Primary completion
- 16 May 2022 (actual)
- Study completion
- 16 May 2023 (estimated)
- First posted
- 29 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm experimental analytical study
| Arm | Type | Receives |
|---|---|---|
| Bromelain + N-Acetylcysteine | Experimental | Drug: Bromelin, Drug: N-AcetylcysteinePatients with pseudomyxoma peritonei that are not candidates to surgical resection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bromelin0.5mg per mL of total tumor volume calculated, administered percutaneously | Drug | Bromelain + N-Acetylcysteine |
| N-Acetylcysteine20mg per mL of total tumor volume calculated, administered percutaneously | Drug | Bromelain + N-Acetylcysteine |
Primary outcome
Tumoral Mass Change
Time frame: 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
4 secondary outcomes
Symptoms improvement
Time frame: Basal visit, 1 month and 12 months after treatment.
TTP (Time to tumor progression)
Time frame: Period of 12 months after treatment.
Overall survival
Time frame: Period of 12 months after treatment.
Tumoral DNA diminution in biological samples
Time frame: Basal visit, all treatment visits and 12 months after treatment is finished.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2022.
- Individual participant dataSharing planned: Yes. Data will be shared after the study concludes and results are published
Related trials for Pseudomyxoma Peritonei
RecruitingPhase 3
Phase 3 Study of Fibrinogen Concentrate (CSL511) in Subjects With Pseudomyxoma Peritonei Undergoing Cytoreductive Surgery
Acquired Fibrinogen Deficiency
Not yet recruitingPhase 2
Intestinal & Multivisceral Transplantation for Unresectable Mucinous Carcinoma Peritonei (TRANSCAPE)
Secondary Malignant Neoplasm of Retroperitoneum, Secondary Malignant Neoplasm of Peritoneum
RecruitingObservational study
Register With Patients in Which Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) Was Performed
Peritoneal Carcinomatosis, Pseudomyxoma Peritonei
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The Appendix Cancer PMP Research Foundation Natural History Study/Patient Registry
Appendix Cancer, Pseudomyxoma Peritonei
RecruitingPhase 2
Metformin in Pseudomyxoma Peritonei Secondary to Appendiceal Mucinous Neoplasms
Appendiceal Mucinous Neoplasm, Pseudomyxoma Peritonei
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lidia Rodríguez Ortiz, MD principal investigator
Hospital General Universitario Reina Sofía de Murcia
Álvaro Arjona Sánchez, PhD principal investigator
Hospital General Universitario Reina Sofía de Murcia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bromelin and N-Acetylcysteine in people with Pseudomyxoma Peritonei, run by Maimónides Biomedical Research Institute of Córdoba at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumoral Mass Change (time frame: Day 3, Day 7 (if it applies),1 month and 12 months after treatment is finished.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2022.