RecruitingPhase 2ACTRN12617001612303

Injection of Bromelain and Acetylcysteine in combination into recurrent mucinous tumour or pseudomyxoma peritonei: a phase I/II study

A phase I/II study to evaluate the safety and efficacy of injection of Bromelain and Acetylcysteine in combination into recurrent mucinous tumour or pseudomyxoma peritonei and aspiration of tumour

Sponsor

Professor David Morris

Enrollment

60 participants

Start Date

Feb 12, 2018

Study Type

Interventional

Conditions

recurrent pseudomyxoma peritonei low grade appendix tumour

Summary

The aim of this study is to evaluate the effect of Bromelain (Br) and Acetylcysteine (NAC) on mucinous tumour in patients that are unsuitable for repeat surgery. Who is it for? You may be eligible to join this study if you are aged between 18 and 80 years and have pseudomyxoma peritonei (PMP) or other mucinous tumour and you are not suitable for surgery. Study details All participants in this study will receive the treatment under investigation. This will involve injection of the combination drug treatment Bromelain and Acetylcysteine directly into the tumour via a drain. The drain will be aspirated 24 hours after the injection is administered. Repeat drug treatments will be considered. Efficacy will be assessed by volume aspirated and repeat radiological imaging. This study will assist with establishing the how well the drug works (efficacy) and its safety when injecting it into mucinous tumours in patients that are unsuitable for surgery.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 80 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests whether injecting a combination of two drugs — Bromelain (an enzyme from pineapple) and Acetylcysteine (a mucus-dissolving agent) — directly into mucinous (jelly-like) tumours in the abdomen can dissolve them in patients who are not candidates for surgery. This is for people with a rare condition called pseudomyxoma peritonei or other mucinous tumours. You may be eligible if: - You are aged 18 to 80 - You have pseudomyxoma peritonei or another mucinous tumour - You are not suitable for or do not want further surgery - Your tumour is soft to intermediate grade (not hard) - The tumour can be safely accessed through the skin by a radiologist You may NOT be eligible if: - You have a non-mucinous (hard) tumour recurrence - You are allergic to pineapples, papain, bromeliads, sulphur, or Acetylcysteine - You have a blood clotting disorder or are on blood thinners that cannot be paused - You have asthma - The tumour appears infected - You are unable to give informed consent or attend follow-up visits Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

This study involves 60 patients with mucinous peritoneal tumour, including pseudomyxoma peritonei (PMP), that are not suitable for cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS/HIPEC) or other potentially beneficial surgery. The combination drug treatment of Bromelain and Acetylcysteine will be injected directly into the tumour or peritoneal cavity via a drain and allowed to dwell for 24 hours. The tumour will then be drained and a repeat treatment will be considered. The injection will be performed under radiological guidance by an interventional radiologist though a percutaneously inserted drain. The drain will remain in situ for the treatment period. The aspiration/drainage and repeat drug treatments will be delivered via this drain. The dose of the drug is dependent on the calculated tumour dimensions and volume. The expectation is that the drug combination will dissolve the tumour, allowing it to be drained. Remaining mucinous tumour that is unable to be drained will be considered for repeat drug treatments.

Locations(2)

St George Hospital - Kogarah

NSW, Australia

Netherlands

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ACTRN12617001612303