Condition category
Circulatory System
Date applied
25/10/2012
Date assigned
31/10/2012
Last edited
23/10/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Simon Noble

ORCID ID

Contact details

Wales Cancer Trials Unit
School of Medicine
Cardiff University
Neuadd Meirionydd
Heath Park
Cardiff
CF14 4YS
United Kingdom
+44 (0)29 2068 7175
simon.noble@wales.nhs.uk

Additional identifiers

EudraCT number

2012-004117-14

ClinicalTrials.gov number

NCT01817257

Protocol/serial number

EudraCT No. 2012-004117-14

Study information

Scientific 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

Acronym

ALICAT

Study hypothesis

The purpose of this study is to address a specific gap in the evidence base for the management of cancer associated Venous Thromboembolism (VTE) in patients with ongoing malignant disease. To address this evidence gap, a sufficiently powered randomised controlled trial (RCT) is needed, to gain information relating to the sample group, which entails a vulnerable adult population, of uncertain number, prognosis, and with uncertainty around willingness to recruitment or likely attrition. Therefore, a trial is proposed specifically to look at the feasibility of progression to a phase 3 RCT, the primary outcome of which would be to determine the proportion of recurrent symptomatic VTE in cancer patients receiving an additional six months LMWH.

The overarching aims of this study are to:
1. To identify practicalities of conducting a full RCT with regard to recruitment, retention and outcome measurement
2.To explore the barriers to progressing to a full RCT

Ethics approval

Not provided at time of registration

Study design

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 UK wide survey exercise.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Cancer Associated Thrombosis

Intervention

Consenting patients will be randomised to one of two trial arms:
Arm A - Continue LMWH at treatment dose according to body weight for further six months.
Arm B - Discontinue LMWH once patient has received six months treatment following index VTE case.

Participants randomised to Arm A will have already received LMWH (Fragmin®), tinzaparin (Innohep®) or enoxaparin (Clexane®) at treatment dose for six months and should continue the same drug at the same dose for a further six months. No dose alterations are required unless clinically indicated.

Participants randomised to Arm B shall stop LMWH once a total of six months drug has been administered from the initial diagnosis of VTE.

Patients in both trial arms will be assessed at baseline, at week 12 of trial treatment and at week 26, i.e. the end of trial treatment. Patients in both trial arms will be given a diary booklet to record any other medications prescribed during the trial period. Quality of life questionnaires (EORTC QLQ-C30, EQ5D, and ESAS-r) will also be completed at these time points. Bleeding, VTE, and SAE events, and death and withdrawal, will be reportable up to 30 weeks after the date of randomisation.

Patients will not be followed up beyond the trial treatment period. However, if a participant is lost to follow up the WCTU will contact the participant's GP to obtain information on the participant's status. Participants will also have the option to consent to NHS IC Flagging for long term follow up of participant cause and date of death.

50-75 semi-structured interviews will be held with:

1. Patients who do not wish to continue with LMWH (non-consenters; 10-15)
2. Trial participants in the intervention arm (10-15);
3. Trial participants in the control arm (10-15);
4. Carers of trial participants (10-15);
5. Participants who withdraw from the study (10-15).

Focus groups with clinicians from oncology, haematology and primary care (two groups per setting; six groups in total) will explore:

1. Attitudes to recruiting to study to identify the challenges of progressing to a full RCT
2. Assessment of equipoise and acceptability of intervention
3. What evidence would be needed, if at all, to convince them to alter their practice in prescribing LMWH
4. Whether they would continue a patient on LMWH after six months
5. Views on the appropriate outcome measures for the RCT
6. Pathways they follow.

Data from the focus groups will be used to map/model the patient management pathways. A UK wide survey exercise will also be undertaken with relevant stakeholders from primary and secondary care. This will be in the form of a telephone/web survey and will allow a classification and enumeration of the models of care. This will also be triangulated with available documentary evidence on pathways of care.

The study will also identify key cost drivers to inform the design of a future definitive trial, which will include a cost utility study. Orders of magnitude of differences in costs and outcomes identified in the EQ-5D will help estimation of anticipated effect sizes for the full trial.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Number of eligible patients over 12 months
2. Number of recruited patients over 12 months (target recruitment rate of 30% of eligible patients)
3. Proportion of participants with recurrent VTEs during follow-up

Secondary outcome measures

1. Completion of trial protocol
2. Quality of life
3. Symptom assessment
4. Attitudes of clinicians and patients

Overall trial start date

01/03/2013

Overall trial end date

28/02/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Receiving low-molecular-weight heparin (LMWH) for treatment of Cancer Associated Thrombosis (CAT) for five months
2. Locally advanced or metastatic cancer
3. Able to self-administer LMWH, or have LMWH administered by a carer
4. Able to give informed consent
5. Age ≥18 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200 patients anonymously registered, 60 patients randomised

Participant exclusion criteria

1. Receiving drug other than LMWH for CAT
2. Contraindication to anticoagulation
2.1. Known allergies to LMWHs, heparin, sulfites or benzyl alcohol
2.2. Active major bleeding
2.3. History of heparin-induced thrombocytopenia
3. Confirmed recurrent VTE whilst receiving anticoagulation
4. Female patients who are pregnant

Recruitment start date

20/12/2013

Recruitment end date

01/07/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Cardiff University
Cardiff
CF14 4YS
United Kingdom

Sponsor information

Organisation

Cardiff University (UK)

Sponsor details

7th Floor
Research and Commercial Division
30-36 Newport Road
Cardiff
CF24 0DE
United Kingdom

Sponsor type

University/education

Website

http://www.cardiff.ac.uk

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK) ref: 10/145/01

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24726032
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26490434

Publication citations

  1. Protocol

    Smith JD, Baillie J, Baglin T, Griffiths GO, Casbard A, Cohen D, Fitzmaurice DA, Hood K, Rose P, Cohen AT, Johnson M, Maraveyas A, Bell J, Toone H, Nelson A, Noble SI, A feasibility study to inform the design of a randomized controlled trial to identify the most clinically and cost effective anticoagulation length with low molecular weight heparin in the treatment of cancer associated thrombosis (ALICAT): study protocol for a mixed-methods study., Trials, 2014, 15, 122, doi: 10.1186/1745-6215-15-122.

  2. Results

    Noble SI,2, 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 identify the most clinically effective and cost-effective length of Anticoagulation with Low-molecular-weight heparin In the treatment of Cancer-Associated Thrombosis (ALICAT), Health Technol Assess, 2015, 19, 83, 1-94, doi: 10.3310/hta19830.

Additional files

Editorial Notes