- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01817257
Anticoagulation Length in Cancer Associated Thrombosis (ALICAT)
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
Study Overview
Status
Intervention / Treatment
Detailed Description
Venous thromboembolism (VTE) is a term to describe blood clots in the legs known as a deep vein thrombus (DVT) or lung, known as a pulmonary embolus (PE). It is a common condition, which causes many symptoms including leg pain, swelling, chest pain and breathlessness. At its most serious, VTE may lead to sudden collapse and death.
Treating VTE costs the UK National Health Service (NHS) £640 million every year, including the long-term complications experienced by nearly a third of patients. VTE treatment usually consists of three to six months blood thinning medicine known as an anticoagulant. For most patients, a tablet called warfarin is used, which requires regular blood tests to ensure the blood is adequately and safely thinned.
We also know that VTE is particularly common in cancer. In the UK, over 250,000 people are diagnosed each year with cancer, of which nearly a fifth will develop VTE. Warfarin is a potentially risky treatment in cancer patients because it may increase the risk of bleeding. Also, VTE may come back in a fifth of patients who are treated with warfarin.
Research has shown that a medicine known as low molecular weight heparin (LMWH) is better than warfarin at treating VTE in cancer patients and decreases the chance of VTE coming back by half. LMWH is given as an injection once a day. Studies have shown that giving the drug as an injection is acceptable to patients, as some patients prefer this to the regular blood tests they need to have for warfarin monitoring. LMWH is also simpler to use since it does not cause problems for patients taking other medicines which is a common problem for patients taking warfarin.
Cancer patients get VTE because the cancer can make the blood sticky and this makes it more likely to clot. It is recommended that patients take LMWH for six months only. However, if someone still has a cancer after six months of treatment with LMWH, there is still a strong chance that the VTE could come back because the cancer causing the blood clots has not gone away. This means that these patients might benefit from taking LMWH for longer than six months. We do not know though whether this would improve the patients' quality of life, help prevent death, or be cost-effective to the NHS.
To help decide if continuing with LMWH would benefit patients, we need to compare the effects of continuing with LMWH for an extra six months with the effects of not continuing LMWH in a clinical trial. Because this has not been done before, the first thing we need to do is see if it would be possible to carry out a full clinical trial with these patients. In other words, will we be able to recruit enough patients, will LMWH be a good treatment for them and will it be a reasonable cost?
To help answer these questions, we propose what is called a feasibility trial. This feasibility trial will compare patients who continue to take LMWH for a further six months with patients who do not continue to take LMWH. Patients with cancer, and who have been taking LMWH for five months for VTE, will be recruited from oncology and haematology outpatients departments and from GP practices.
Patients who are approached to take part in the study will be asked if they would be willing to continue with LMWH for a further six months as part of a research study. If they say yes, then they will be chosen at random to either receive the LMWH for a further six months (intervention group), or to stop LMWH at six months, which is usual care (control group). We will follow up patients for six months from recruitment and ask them to complete questionnaires at three monthly intervals. These questionnaires will ask about their symptoms and quality of life.
We will interview patients who do not wish to consent to the study to explore their reasons why. We will also interview patients who do consent to the study, but who later withdraw from the study to explore their experiences and reasons for withdrawal. We will also explore the views of clinicians towards continuation of LMWH and how they feel about the trial. Focus groups will be held with two groups of clinicians from each care setting. By collecting this information, we will be able to explore whether continuing with LMWH is something that is acceptable to patients and their health care professionals and if there are any side effects with continuing LMWH.
The research team is made up of experienced researchers from all health care settings (GPs, hospital doctors and nurses and health care professionals working in charity organisations). They are supported by approved clinical trials units, which are experienced in running large studies in all areas. The team members also have links to many national and international professional, policy and patient groups, which will be essential to help report the findings of this study.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Cardiff, United Kingdom
- Velindre NHS Trust (Velindre Cancer Centre)
-
Newport, United Kingdom
- Aneurin Bevan Health Board (Royal Gwent Hospital)
-
Warwick, United Kingdom
- South Warwickshire NHS Foundation Trust (Warwick Hospital)
-
-
Warwickshire
-
Nuneaton, Warwickshire, United Kingdom
- George Eliot Hospital NHS Trust (George Eliot Hospital)
-
-
Worcestershire
-
Worcester, Worcestershire, United Kingdom
- Worcestershire Acute Hospitals NHS Trust (Worcester Royal Hospital)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: A: Continue treatment
Continue low molecular weight heparin (LMWH) at treatment dose according to body weight for further six months.
|
Participants randomised to Arm A will have already received LMWH (Fragmin®), tinzaparin (Innohep®) or enoxaparin (Clexane®) at treatment dose for six months off trial, and should continue the same drug at the same dose for a further six months on trial.
No dose alterations are required unless clinically indicated.
Other Names:
|
NO_INTERVENTION: B: Discontinue treatment
Discontinue low molecular weight heparin (LMWH) once patient has received six months treatment following index VTE case.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
Time Frame: 24 months
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of life
Time Frame: 24 months
|
24 months
|
|
Completion of trial protocol
Time Frame: 24 months
|
24 months
|
|
Symptom assessment during the study
Time Frame: 24 months
|
Toxicities, including bleeding events and VTEs, will be assessed during the 6 month trial treatment period.
|
24 months
|
Attitudes of clinicians and patients to extended treatment with LMWH
Time Frame: 24 months
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Simon Noble, Dr, Cardiff University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Embolism and Thrombosis
- Embolism
- Thrombosis
- Venous Thrombosis
- Thromboembolism
- Venous Thromboembolism
- Pulmonary Embolism
- Molecular Mechanisms of Pharmacological Action
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Anticoagulants
- Heparin
- Enoxaparin
- Heparin, Low-Molecular-Weight
- Tinzaparin
- Dalteparin
Other Study ID Numbers
- SPON1037-11
- to be assigned (OTHER: EGMS)
- 10/145/01 (OTHER_GRANT: NIHR HTA)
- 2012-004117-14 (EUDRACT_NUMBER)
- WCTU062 (OTHER: WCTU)
- ISRCTN37913976 (OTHER: ISRCTN)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cancer
-
University of Michigan Rogel Cancer CenterRecruitingCancer Liver | Cancer Brain | Cancer Head &Neck | Cancer PelvisUnited States
-
Cellworks Group Inc.RecruitingCancer | Relapsed Cancer | Refractory CancerUnited States
-
UNC Lineberger Comprehensive Cancer CenterHyundai Hope On WheelsRecruitingCancer | Pediatric Cancer | Survivorship | Cancer MetastaticUnited States
-
Vanderbilt-Ingram Cancer CenterNational Institutes of Health (NIH)Active, not recruitingAdvanced Cancer | Relapsed Cancer | Refractory CancerUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)CompletedStage III Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IV Gastric Cancer | Stage IVA Colorectal Cancer | Stage IVA Pancreatic Cancer | Stage IVB Colorectal Cancer | Stage IVB Pancreatic Cancer | Stage IIIA Gastric Cancer | Stage IIIB Gastric Cancer | Stage IIIC Gastric... and other conditionsUnited States
-
MiRXES Pte LtdRecruitingBreast Cancer | Gastric Cancer | Colorectal Cancer | Pancreatic Cancer | Esophageal Cancer | Ovarian Cancer | Prostate Cancer | Thoracic Cancer | Liver CancerSingapore
-
Sidney Kimmel Cancer Center at Thomas Jefferson...CompletedStage I Breast Cancer | Stage I Uterine Corpus Cancer | Stage II Uterine Corpus Cancer | Stage III Uterine Corpus Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage... and other conditionsUnited States
-
Massachusetts General HospitalNational Comprehensive Cancer NetworkCompletedGastric Cancer | Pancreatic Cancer | Esophageal Cancer | Rectal Cancer | Colon Cancer | Hepatobiliary CancerUnited States
-
University of California, San FranciscoBristol-Myers Squibb; PfizerTerminatedStage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Stage IIIC Rectal Cancer | Metastatic Colorectal Adenocarcinoma | Metastatic Colon Adenocarcinoma | Metastatic Rectal Adenocarcinoma | Stage IIIA Colon Cancer | Stage IIIB Colon Cancer | Stage IIIC Colon Cancer | Stage IV Colon Cancer | Stage IV Rectal... and other conditionsUnited States
-
Johns Hopkins UniversityNational Cancer Institute (NCI); National Institute on Minority Health and...Enrolling by invitationCancer | Advanced Cancer | End Stage Cancer | MalignancyUnited States
Clinical Trials on Low Molecular Weight Heparin (LMWH)
-
Quovadis AssociazioneUniversity of PadovaCompletedCOVID-19 | HypercoagulabilityItaly
-
Shen LeiCompleted
-
Aimin ZhaoRecruitingRecurrent Spontaneous AbortionChina
-
Ohio State UniversityOsato Research InstituteCompletedWound | Negative Pressure Therapy | Open Wound | Type II Obese Diabetic | Type II Non-Obese DiabeticUnited States
-
McMaster UniversityCanadian Institutes of Health Research (CIHR); Australian and New Zealand Intensive... and other collaboratorsCompletedCritical Illness | Deep Venous ThrombosisUnited States, Australia, Canada, Saudi Arabia, Brazil, United Kingdom
-
Hamilton Health Sciences CorporationCanadian Institutes of Health Research (CIHR); Canadian Critical Care Trials...CompletedCritically Ill | Deep Venous ThrombosisCanada, Australia
-
University of ParmaTerminatedPostoperative Complications | Thrombelastography | Coagulation, Blood | Compression Devices, Intermittent PneumaticItaly
-
Dr.Vandana BansalUnknownTo Investigate the Effects of Low Dose Aspirin and Low Molecular Weight Heparin in IVF Out ComeIndia
-
McMaster UniversityCompletedLung Neoplasms | Venous Thromboembolism | Pulmonary EmbolismCanada