Cancer Clinical Trial
— ALICATOfficial title:
A Feasibility Study to Inform the Design of a Randomised Controlled Trial to Identify the Most Clinically and Cost Effective Length of Anticoagulation With Low Molecular Weight Heparin In the Treatment of Cancer Associated Thrombosis
Verified date | October 2018 |
Source | Cardiff University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a two year, multicentre, mixed methods feasibility study including a randomised controlled two-arm interventional trial, a nested qualitative study, focus groups and a United Kingdom (UK) wide survey exercise.
Status | Terminated |
Enrollment | 2 |
Est. completion date | February 2015 |
Est. primary completion date | February 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years and older |
Eligibility |
Inclusion Criteria: - Receiving LMWH for treatment of CAT for five months - Locally advanced or metastatic cancer - Able to self-administer LMWH, or have LMWH administered by a carer - Able to give informed consent - Age =16 years Exclusion Criteria: - Receiving drug other than LMWH for CAT - Contraindication to anticoagulation - Fitted with a prosthetic heart valve - Pregnant and/or lactating females |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Velindre NHS Trust (Velindre Cancer Centre) | Cardiff | |
United Kingdom | Aneurin Bevan Health Board (Royal Gwent Hospital) | Newport | |
United Kingdom | George Eliot Hospital NHS Trust (George Eliot Hospital) | Nuneaton | Warwickshire |
United Kingdom | South Warwickshire NHS Foundation Trust (Warwick Hospital) | Warwick | |
United Kingdom | Worcestershire Acute Hospitals NHS Trust (Worcester Royal Hospital) | Worcester | Worcestershire |
Lead Sponsor | Collaborator |
---|---|
Cardiff University | National Institute for Health Research, United Kingdom, Wales Cancer Trials Unit |
United Kingdom,
Noble SI, Nelson A, Fitzmaurice D, Bekkers MJ, Baillie J, Sivell S, Canham J, Smith JD, Casbard A, Cohen A, Cohen D, Evans J, Fletcher K, Johnson M, Maraveyas A, Prout H, Hood K. A feasibility study to inform the design of a randomised controlled trial to — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of eligible and recruited patients (target recruitment rate of 30% of eligible patients) over 12 months, and proportion of participants with recurrent VTEs during follow-up. | 24 months | ||
Secondary | Completion of trial protocol | 24 months | ||
Secondary | Quality of life | 24 months | ||
Secondary | Symptom assessment during the study | Toxicities, including bleeding events and VTEs, will be assessed during the 6 month trial treatment period. | 24 months | |
Secondary | Attitudes of clinicians and patients to extended treatment with LMWH | Attitudes of clinicians and patients to extended treatment with LMWH will be assessed through clinician focus groups and qualitative interviews with patients and carers. | 24 months |
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