None listed
Conditions
Brief 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.
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
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.
Sponsors
Professor David Morris
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Patients with PMP or mucinous tumour who are not candidates for CRS/HIPEC or other surgery, have soft to intermediate grade tumour and do not meet any exclusion criteria Patients will be considered for entry into this study if they: • Are 18 – 80 years old • Have a mucinous tumour or pseudomyxoma peritonei (target or free intraperitoneal) as identified on prior histology • Are considered at high risk for repeat surgery, or do not wish to explore repeat surgery and consent to the trial procedures • Have soft to intermediate grade tumour as identified on prior histology or operation • Are considered suitable for the trial based on multidisciplinary team meeting review Tumour should not be hard tumour or caking and have a clear cystic or mucinous appearance as identified on radiology. Having hard tumour in one region does not exclude treatment in another area, provided the appearance is mucinous. In the case of a target lesion, tumour located elsewhere will not exclude a patient from this study and these tumours may be treated if suitable. The tumour must be safely accessible percutaneously by an interventional radiologist to allow insertion of a catheter or drain
Exclusion criteria
Exclusion criteria Patients will be excluded from the study if they: • Have a non-mucinous tumour recurrence (hard tumour) • Have suspected fistulisation of the tumour into the gastrointestinal tract, invading or abutting major vessel or other area of concern • Have an allergy to pineapples, papain or bromeliads, sulphur or Acetylcysteine (skin tests will be performed in any patient where allergy or sensitivity is unknown) • Have a coagulation disorder of any kind or are on anticoagulant or anti-platelet therapy that can not be managed or withheld for the treatment period • Are asthmatic • Have infected tumour (pus on aspiration or indicated on blood test) • Have other serious comorbidities where inclusion in the trial will subject the patient to a higher risk of adverse events • Are unable to give fully informed and educated consent or are unable to comply with the standard follow up procedures of a clinical trial • Considered by the interventional radiologist to not be percutaneously accessible
Outcome results
None listed