None listed
Conditions
Brief summary
The purpose of this study is to test the safety and tolerability of the medication ‘enoxaparin’ for the prevention of blood clots in patients receiving anti-cancer treatment. Who is it for? You may be eligible for this study if you are an adult patient with lung or gastrointestinal cancer that is planned to commence anticancer therapy as an outpatient. Study details All consenting patients will have blood tests to assess their risk of developing a blood clot. Patients identified as ‘high risk’ will be randomised to their usual cancer treatment with or without enoxaparin for clot prevention. Patients identified as ‘low risk’ will be observed and then re-assessed one month after commencement of cancer therapy, and if fulfilling requirements for ‘high risk’, will be randomised and included in the study. Participants will be followed up at 1, 3, 6 and 12 months after randomisation, and yearly thereafter until the study is closed. Study aims It is hoped that this research will demonstrate that routine clot risk assessment and personalised preventative interventions can reduce the incidence of blood clots and improve patient outcomes.
Interventions
Standard of care anticancer treatment plus enoxaparin thromboprophylaxis 40mg self-administered subcutaneously once daily for minimum 3 months, or until completion of anticancer therapy, to maximum 6 months (adherence monitored by drug returns).
Sponsors
Peter MacCallum Cancer Centre
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient is 18 years of age or older 2. Patient has a confirmed histological diagnosis of any gastrointestinal or lung cancer 3. Patient is newly diagnosed treatment-naïve or is previously treated with newly relapsed or progressive disease 4. Patient is being considered for, but has not commenced anticancer therapy including chemotherapy and/or radiotherapy and/or immunotherapy and/or targeted therapies, within neoadjuvant, adjuvant, curative, or palliative treatment settings 5. Patient has expected life expectancy of at least six months, as estimated by their treating clinician 6. Patient has provided written confirmation of informed consent on participant information and consent form
Exclusion criteria
1. Patients who have already commenced anticancer therapy 2. Patients with a clinical indication for therapeutic anticoagulation (antiplatelet agents such as clopidogrel and aspirin are permitted) 3. Patients with a contraindication to anticoagulation and/or specifically low molecular weight heparin 4. Cancer diagnosis other than those specified in inclusion criteria
Outcome results
None listed