Frailty is a condition of increased vulnerability to major changes in health as a result of seemingly small problems, such as an infection or new medication. It is common in older age, affecting around 10% of people aged over 65, and develops because as we get older our bodies change and can lose their inbuilt reserves, for example we lose muscle strength. People with frailty are at increased risk of falls, disability, loneliness, hospitalisation and care home admission. These problems can reduce quality of life and are costly for the NHS and social care.
We have received £2.7 million of funding from the National Institute for Health Research to develop and test a new type of care which aims to improve the quality of life for older people with frailty by giving them choice and control over decisions about their own health and wellbeing.
The new type of care, called personalised care planning, is designed to improve self-management skills and help older people with frailty to improve their wellbeing and thrive with the support of their community. This approach also aims to improve coordination of GP, voluntary sector and social care services and increase the social networks of older people with frailty.
The overall aim of this five year research programme is to find out whether personalised care planning improves quality of life for older people living with frailty, and is cost-effective. The team plan to identify which people should receive personalised care planning by studying how quality of life and use of health and social care services changes as frailty develops. They will also study the existing Age UK Personalised Integrated Care Service, designed to provide person-centred care planning for older people, to see how it might be improved, in preparation for a large trial to test effectiveness, involving 2,000 older people across Yorkshire & Humber and Greater Manchester.
LOTUS is an international follow up study for patients with breast cancer who have previously taken part in the BEATRICE trial. Our hope with LOTUS is to better study the long-term outcomes of ‘triple negative’ breast cancer patients (meaning patients whose cancers do not have receptors for the hormones oestrogen and progesterone or the protein Her2), particularly looking at cancer recurrence, survival and cardiovascular problems for these patients at the 10 years point after completing treatment on the BEATRICE breast cancer trial.
Only patients who previously took part in the BEATRICE trial can take part in LOTUS, and we have so far recruited 219 participants across 8 hospitals in the UK and another 11 hospitals in Europe, Asia, New Zealand and Canada. While taking part in the study participants come to a follow up clinic visit every year on the anniversary of when they joined the BEATRICE trial, and at the 10 year follow up visit participants have some additional cardiac assessments including their blood pressure and an Echocardiogram. The CTRU in Leeds is running the study and the study’s Chief Investigator Prof David Cameron is based at the University of Edinburgh, and the funding for the study has come from the pharmaceutical company Roche who funded the original BEATRICE trial.
Alitretinoin tablets and PUVA hand baths are both used by doctors in the treatment of hand eczema, but there is no clear evidence of which of these two treatments are the most effective. The ALPHA trial compares Alitretinoin and PUVA therapy in patients with severe hand eczema to find out which is the most effective in treating the condition.
The study directly compares the two treatments to examine:
Ondansetron has been widely used for over 25 years to prevent nausea and vomiting after surgery and during ongoing cancer treatment.
The TRITON study is investigating whether ondansetron can improve diarrhoea symptoms in Irritable Bowel Syndrome (IBS). It is an NIHR EME funded trial recruiting 400 patients which involves
This clinical trial has been designed to test whether a naturally-occurring omega-3 fatty acid called eicosapentaenoic acid (EPA for short) improves outcomes in patients who have a liver operation for removal of bowel (also known as colorectal) cancer that has spread to the liver.
A small trial in Leeds suggested that a high-purity, high-dose preparation of EPA might be beneficial but only a bigger trial can give us a definite answer as to whether taking EPA will work. The EPA capsules are being compared with dummy (placebo) capsules so that we can be sure that EPA is or isn’t better than no supplement at all.
Taking part involves starting trial capsules before the operation and then continuing them after surgery even if the bowel cancer comes back. There are trial visits every 6 months that can either be combined with outpatient clinic visits or by telephone, if the hospital is a long way away.
Trial tests include the check-up CT scans that would be performed by the hospital department anyway, but also questionnaires about quality of life and some patients will be asked for extra blood tests.
Frail older people who are hospitalised for acute injury or illness are at risk of sudden change in health status leading to hospital readmission or death following discharge home. This is chiefly due to loss of muscle mass and strength. Some patients are referred into intermediate care services which provides short-term rehabilitation. Many patients don’t feel ready to leave the IC service, indicating incomplete recovery. Exercise has positive physiological effects on muscle, brain, endocrine system and inflammation.
The HOPE (Home-based Older People’s Exercise) programme is a home-based exercise programme designed to improve strength, endurance and balance, delivered by physiotherapists after a patient has been discharged from normal rehabilitation services. The aims of the HERO trial are to establish the clinical and cost effectiveness of the HOPE programme compared to usual care. Outcomes are to establish if HOPE:
PRISM is looking at different methods of giving first-line immunotherapy treatment to patients with advanced renal cell cancer. The drugs being used are called ipilimumab and nivolumab and PRISM is investigating the optimum schedule in which they should be administered in order to give the best results for patients.
PRISM is researching two different schedules; one is the schedule used in standard practice and the other schedule is modified to give the drugs less frequently but over a longer time period. We are hoping that the modified schedule will reduce the impact of any side effects whilst maintaining effectiveness as a treatment for renal cell cancer.
PRISM is set to close to recruitment soon, having met its recruitment target ahead of schedule.
NET-02 is comparing two treatments which are currently commonly used for patients with poorly differentiated, extra-pulmonary neuroendocrine cancer: one is a combination of chemotherapy drugs (liposomal irinotecan, 5-fluorouracil and folinic acid), the other is a single chemotherapy drug called docetaxel. There is currently little evidence from clinical trials about which treatment is best for these patients.
The trial’s aim is to work out which of these two treatments works best so we can decide which one to study further in a bigger clinical trial, and develop better evidence for treating patients with this type of cancer.
PLATO is an integrated protocol, comprising 3 separate trials (ACT3, ACT4 and ACT5) which aims to optimise radiotherapy dose (in combination with chemotherapy) for low-, intermediate- and high-risk anal cancer.
ACT3 is a non-randomised phase II trial for patients with early, small tumours who have undergone surgery. The aim of this study is to determine whether a treatment strategy of surgery alone, i.e. no further treatment, for patients with margins >1mm, and highly selective low-dose radiotherapy with chemotherapy for patients with close margins ≤1mm, results in acceptably low rates of cancer recurrence.
ACT4 is a randomised phase II trial for patients with intermediate-risk disease. The aim of this study is to compare standard-dose chemoradiotherapy with reduced-dose chemoradiotherapy, to see if less radiotherapy is able to maintain the excellent success rates in treating the cancer, while reducing the side effects of treatment.
ACT5 is a randomised seamless pilot/phase II/phase III trial for patients with locally advanced anal cancer. The aim of this study is to compare standard-dose chemoradiotherapy with two higher doses of chemoradiotherapy, to see if giving a higher dose of radiotherapy reduces the chance of the cancer coming back, whilst not causing too many extra side effects.
FLAIR is a high-recruiting, randomised, clinical trial studying the treatment of Chronic lymphocytic leukaemia (CLL). Current chemotherapy treatments have improved survival times for CLL but can involve significant toxicity for the patients, with the majority relapsing and requiring further treatment. FLAIR is, therefore, comparing the current gold-standard treatment (FCR) against new, targeted treatments (either Ibrutinib alone or in combination with Venetoclax).
It is hoped that the new treatments will improve outcomes for patients and have reduced toxicities.
Approximately 110,000 people suffer a stroke annually in England, around a quarter who are of working age. Evidence shows that stroke survivors who do not return to work within 2years post-stroke are unlikely to return, which in turn has a huge economic impact as well as reduced quality of life and poorer psychosocial outcomes for those effected.
The RETAKE (RETurn to work After stroKE) study is a national study which is aimed at assessing whether a stroke-specific vocational rehabilitation delivered early in the stroke pathway (within 8 weeks of stroke) alongside usual NHS rehabilitation is more effective and cost effective at returning stroke survivors to work and keeping them there at 12 months post-randomisation in comparison to usual NHS rehabilitation alone.
The RETAKE study is currently open to recruitment with a recruitment target of 760 stroke survivors (and their carer (if applicable)) across 20 hospitals.
The APHRODITE study aims to assess whether a higher radiotherapy dose is effective in the eradication of early stage rectal cancer. APHRODITE is open to any patients with early stage non-metastatic, biopsy-confirmed rectal adenocarcinoma who are deemed by their multi-disciplinary team at hospital to be unsuitable for radical total mesorectal excision (TME) surgery. This may be due to either an increased risk of surgical complications, or marked anxiety at the prospect of a stoma, or expected difficulties managing a stoma post-operatively.
All patients will be allocated to receive either the standard dose radiotherapy treatment or an escalated dose radiotherapy treatment over 5 ½ weeks of treatment, with an additional option to use concurrent chemotherapy at the same time. Patients will be followed up, initially via a phone call 2 weeks after completion of their radiotherapy, and then via clinical visits at 3, 6, 9, 12 and 24 months after the start of treatment.
MIDFUT is a study finding out the best way to treat DFUs. We are comparing combinations of different treatments including; hydrosurgical debridement (a machine called “VERSAJET” that uses a stream of water to remove dead skin), negative pressure wound therapy (a sealed dressing covering the ulcer which is attached to a pump), decelluarised dermis (a skin graft made from donated skin with all human cells removed) and treatment as usual (care as detailed in national guidelines including removing dead skin if needed, dressings, bandages, reducing pressure on the wound, diabetes management).
Myeloma is a bone marrow cancer with over 5000 patients diagnosed in the UK each year. About two thirds of patients are aged over 70 at diagnosis. Patient outcomes are improving with new treatments, but this has been less noticeable in older, less fit patients (patients who might be unsuitable for stem cell transplant), and we would like to see if we can change this.
A scoring system for frailty has been developed which looks at age, other illnesses and whether people can live independently to decide what doses of myeloma treatment patients should start on. This study will look at whether using this scoring system to assign different doses from the beginning of treatment could help patients tolerate their treatment better, improve their outcomes (especially in the short-term), and give them a better quality of life.
In addition to the new scoring system, this study will be looking at a newer targeted therapy drug called Ixazomib (also known as NINLARO®) alongside treatments called lenalidomide (also known as Revlimid®) and Dexamethasone which have been used for some years, to see if it offers any benefit to this group of patients.
The CODIFI2 trial is a randomised controlled trial (RCT) comparing two wound sample collection techniques (swab and tissue sampling) in clinically infected diabetic foot ulcer (DFU) patients, with blinded outcome assessment, with 3 embedded Sub-studies
A total of 730 eligible and consenting participants will be randomised in a 1:1 allocation ratio to either swab or tissue sampling from randomisation to the end of the interventional period (defined as randomisation to a minimum of week 52 and maximum week 104 post randomisation.
NEPTUNE is hoping to find the best treatment for patients diagnosed with advanced breast cancer that has spread to the bones. This study will help us learn more about the use of two new anti-cancer treatments, avelumab and radium-223. Patients will either receive avelumab alone or radium-223 in combination with avelumab. We hope to find out how effective these treatments are at controlling this type of cancer.
Cells in the immune system are designed to recognise and kill cancer cells. However, cancer cells have developed different processes by which they can avoid being killed. Avelumab is an immunotherapy that works to free immune cells from the blocks, or brakes, which are put in place by cancer cells. Avelumab enables immune cells to recognise and kill cancer cells.
It has been found that radiotherapy can make immunotherapy like avelumab more effective in the areas directly targeted by the radiotherapy, and also in other areas that the cancer has spread to. Radium-223 delivers radiotherapy treatment directly to the bones in areas where the cancer exists. For this reason, it is thought to be an effective treatment for bones without causing significant side effects.
RADAR (Myeloma XV) is a clinical trial for newly diagnosed multiple myeloma patients. The aim of RADAR is to investigate precision medicine, allocating treatment to patients based on the genetics of their myeloma and response to treatment. It has been found that some patients with myeloma have genetic abnormalities in the myeloma cells, and these ‘high-risk’ patients do not respond well to standard treatment. Some patients without these genetic abnormalities, ‘standard-risk’ patients, are also known to not respond as well to initial therapy. RADAR will investigate different treatment combinations, including current and new drug combinations, for these two groups of patients. RADAR will also investigate whether a third group of patients, who do respond well to initial treatment, can receive treatment for a shorter period of time without coming to harm.
Treatment will comprise of combinations of isatuximab (a new treatment), bortezomib, cyclophosphamide, lenalidomide and dexamethasone. All patients will start on the same initial chemotherapy treatment followed by a course of treatment determined by the patients’ genetic risk and response to the initial chemotherapy.
Patients will be required to have bone marrow, blood and urine tests throughout the trial as well as being asked to complete questionnaires about their quality of life.
ReoGlio is investigating whether a virus called a reovirus can help in the treatment of glioblastoma, which is a type of brain cancer. The patients taking part had received surgery to remove all or part of their brain tumour but had not had any other treatment before joining the trial. They were then treated with radiotherapy, temozolomide (a type of chemotherapy) and Reolysin (a modified reovirus).
This trial aims to find the dose of Reolysin that is safest when combined with these other treatments, and to find the side effects that occur.