A feasibility study to inform the design of a randomised controlled trial to identify the most clinically and cost effect length of anticoagulation with low molecular weight heparin in the treatment of Cancer Associated Thrombosis
ALICAT is a Phase II, mixed methods 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 (LMWH) In the
treatment of Cancer Associated Thrombosis (CAT). The trial has been developed on behalf of the Chief Investigator, Dr Simon Noble, Cardiff University. The trial is sponsored by Cardiff University and funded by NIHR HTA (project reference: 10/1/45//01).
The study has four components:
- A randomised controlled trial (RCT) comparing ongoing LMWH treatment for CAT vs. cessation of LMWH at six months treatment current licensed practice) in patients with locally advanced or metastatic cancer. Patients will be recruited in two stages. Stage 1 will be considered complete once 62 patients have been registered. If at least 15 out of these 62 participants accept randomisation, then we will continue recruitment in stage 2 of the trial, until 200 patients have been registered in total over a period of12 months. Participants will be randomised to the trial arm (continue treatmentwith LMWH for a further 6 months) or the control arm (stop treatment with LMWH). Participants will be assessed at baseline and at 3 and 6 months after the date of randomisation.
- A nested qualitative study to explore attitudes towards participating in the study; potential barriers and concerns to participation; factors influencing compliance with self-injecting (where appropriate). Interviews shall be held with patients who do not wish to continue with LMWH; trial participants in the intervention arm; trial participants in the control arm; darers of trial participants; Patients who withdraw from the study.
- Focus groups with clinicians from oncology, haematology and primary care will explore attitudes to recruiting to the study,to identify the challenges of progressing to a full RCT.
- A UK wide survey exercise to develop a classification and enumeration system for the CAT models and pathways of care.
The primary endpoints are:
- Number of eligible patients over 12 months
- Number of recruited patients over 12 months (target recruitment rate of 30% of eligible patients)
- Proportion of participants with recurrent VTEs during follow-up
The secondary endpoints are:
- Completion of trial protocol
- Quality of life
- Symptom assessment
- Attitudes of clinicians and patients
- Email address
- ISRCTN 37913976
- UK Clinical Trials Gateway
- EU Clinical Trials Register
- Trial number 2012-004117-14
- UK Clinical Research Network
- Study number 14156
- Start date
- Sept. 1, 2012
- End date
- Jan. 31, 2015
- Grant value
- General enquiries
- Dr Lisette Nixon
- Chief investigators
- Dr Simon Noble