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Past studies

Below are some key examples of trials we've recently completed with our partners. Find out more about working with us.

Full title: A Randomised Feasibility Trial to Investigate the Timing of HDR Brachytherapy with EBRT in Intermediate and High Risk Localised Prostate Cancer Patients and its Effects on Toxicity and Quality of Life

The THEPCA trial was a randomised control trial to examine the timing of high dose rate (HDR) brachytherapy with external beam radiotherapy (EBRT) for prostate cancer, and the side effects associated with the treatment.

Prostate cancer is the most common cancer in UK males, affecting around 105 cases for every 100,000 men. The role of radiotherapy in the management of prostate cancer has changed significantly over the last few decades with developments in brachytherapy, EBRT, intensity modulated radiotherapy and image guided radiotherapy. A challenging factor of radiotherapy treatment of localised prostate cancer is acute and late genitourinary and gastrointestinal toxicities.

Radiotherapy is needed to treat prostate cancer and a combination of EBRT and high dose rate brachytherapy is a well-recognised mode of treatment. However, it is not clear from the evidence which sequence of the above treatments (i.e. brachytherapy either before or after the EBRT) would result in the least side effects.

Trial setting, design, and methods

This was a single-site trial conducted at Southend Hospital University NHS Trust.

This study was a randomised, two-arm trial in which intermediate and high-risk prostate cancer patients were treated with both HDR brachytherapy and EBRT. In the intervention arm, patients received HDR brachytherapy before EBRT. In the control arm, patients received EBRT before HDR brachytherapy. The assessment of the acute and late toxicities at various time points was carried out.

The trial recruited a total 50 participants to each arm.

Trial objectives

The primary objective was the prospective assessment of genitourinary toxicities related to the treatment sequence of HDR brachytherapy and EBRT. As part of the study, secondary objectives were also assessed.

Outputs

Choudhury, M., Sibhu Thomas, S., Cain, A., Palvai, S., Nageshwaran, S., Zhang, J., Hayden, K., Cain, A., Hoskin, P. and Ahmed, I. (2023) 'Timing of High-Dose-Rate Brachytherapy With External Beam Radiation Therapy in Patients With Intermediate and High-Risk Localized Prostate Cancer and Its Effects on Toxicity and Quality of Life: A Randomized Controlled Trial (THEPCA)', Int J Radiat Oncol Biol Phys, S0360-3016(23)08137-3. Available at: https://doi.org/10.1016/j.ijrobp.2023.11.011

Palvai, S., Harrison, M., Shibu Thomas, S., Hayden, K., Green, J., Anderson, O., Romero, L., Lodge, R., Burns, P. and Ahmed, I. (2015) 'Timing of High-Dose Rate Brachytherapy With External Beam Radiotherapy in intermediate and High-Risk Localized Prostate Cancer (THEPCA) Patients and its Effects on Toxicity and Quality of Life: Protocol of a Randomized Feasibility Trial', JMIR Research Protocols, 4(2), e49. Available at: https://doi.org/10.2196/resprot.4462




Chief Investigator: Dr Imtiaz Ahmed (Southend Hospital)
ARCTU involvement: Trial management; database; randomisation service; statistical service
Trial sponsor and funding: Southend Hospital University NHS Foundation Trust (now Mid and South Essex NHS Foundation Trust) (sponsor and funder)
Project reference number: ISRCTN: ISRCTN15835424

Read more about more about thepca.

Full title: A randomised controlled clinical trial comparing the effectiveness of bandaging compared to the Juxta Cures™ device in the management of people with venous ulceration: Feasibility Study

The MAVEN study compared the effectiveness of compression bandaging and the Juxta-Cures™ device in the management of people with venous ulceration.

Current treatment for venous ulceration involves bandaging therapy, which is replaced on a once or twice weekly basis. The Juxta-Cures™ device offers an alternative solution for the long-term treatment of patients with venous ulceration. This is a removable adjustable device with an inbuilt pressure monitor.

The aim of this study was to determine whether the Juxta-Cures™ device provides at least equivalent ulcer healing for patients with venous ulceration compared to bandaging.

Trial setting, design, and methods

This was a single-site trial conducted at Colchester Hospital University NHS Foundation Trust.

It was a feasibility, unblinded, randomised controlled trial in which 40 patients were randomised to receive either compression bandages or Juxta-Cures™. Participants were followed up for 26 weeks.

Trial objectives

The primary objective of the study was to determine the feasibility of running a randomised controlled trial comparing compression bandaging and the Juxta-Cures™ device. As part of the study, secondary objectives were also assessed.

Outputs

Stather, P., Petty, C., Langthorne, H., Rayner, E., Zhang, J., Hayden, K. and Howard, A. (2021) 'A randomised controlled clinical trial comparing the effectiveness of bandaging compared to the JuxtaCures™ device in the management of people with venous ulceration: Feasibility study', Phlebology, 36(7), pp. 505-514. Available at: https://doi.org/10.1177/0268355520988226




Chief Investigator: Mr Adam Howard (Colchester Hospital)
ARCTU involvement: Trial management; database; randomisation service; statistical service
Trial sponsor and funding: Colchester Hospital University NHS Foundation Trust (now East Suffolk and North Essex NHS Foundation Trust) (sponsor); MEDI UK (Hereford) (funder)
Project reference number: ClinicalTrials.gov: NCT02790593

Read more about more about maven.

Full title: Support monitoring and reminder technology for mild dementia

SMART4MD was an EU-wide research project focused on empowering people with mild dementia and on supporting their carers, by creating a system designed to help with adherence to treatment and sharing health-related data.

It is estimated that around nine million people are living with dementia in Europe.

Dementia is a syndrome or set of symptoms, typically involving loss of memory, mood changes and problems with thinking, orientation, comprehension, calculation, learning capacity, language, and judgement. These symptoms tend to develop gradually over a lengthy period of time, as the brain becomes impaired due to damage from the underlying dementia condition.

Dementia is not a disease per se. There are over a hundred types of dementia and most are caused by or associated with a specific disease, the most common one being Alzheimer’s disease (AD). Although dementia is a medical condition, it has a social, psychological, emotional, and economic impact on people’s lives. It affects people in different ways.

This multi-centre randomised control trial aimed to evaluate the effects of an intervention consisting of a health application developed to improve the quality of life (QoL) in older people with mild dementia and their informal caregivers. The study was a collaboration between five European countries where the clinical trial was conducted in four of these countries (Sweden, Belgium, Spain and Czech Republic).

Trial setting, design, and methods

This was a four-year project, involving ten project partners from industry and academia and with five clinical sites around Europe. In total 1,200 dyads (consisting of a person with mild dementia (PWD) and their informal caregiver (carer)) were recruited for this study.

Participant dyads were randomised to two parallel groups: PWD to receive either usual care from primary or specialised providers (control group) or to receive usual care plus access to a tablet with the SMART4MD health application (intervention group). Participants in the trial were assessed for a period of 18 months.

Trial objectives

The aim of the SMART4MD project was to validate a novel support tool for patients with mild dementia (MD), helping them to maintain their independence and quality of life.

The tool was based on the established, but innovative Healthbit mobile application that reminds patients of activities in their treatment plan and allows patients to share information with their doctors and carers.

In its original guise, the Healthbit platform was not optimised for use by MD patients and unproven for their condition. The projects aimed to address this through four objectives:

  1. Adapt the platform specifically for MD patients (SMART4MD), through user-centric design
  2. Validate SMART4MD’s benefits for users through large-scale pilots
  3. Assess the financial savings that SMART4MD provides to healthcare systems
  4. Prepare for sustainable pan-European roll-out of the application.

Outputs

Support, Monitoring and Reminder Technology for Mild Dementia fact sheet




Clinical Lead: Johan Sanmartin Berglund (Blekinge Institute of Technology, Sweden)
ARCTU involvement: Project coordination; randomisation service; statistical service
Trial sponsor and funding: Johan Sanmartin Berglund, Blekinge Institute of Technology, Sweden (sponsor); EU Framework Programme for Research and Innovation Horizon 2020 (funder)
Project reference number: ClinicalTrials.gov: NCT03325699; Horizon grant: 643399

About the EU Framework Programme for Research and Innovation - Horizon 2020:
Horizon 2020 is the biggest EU Research and Innovation programme ever with nearly €80 billion of funding available over seven years (2014 to 2020) – in addition to the private investment that this money will attract. It promises more breakthroughs, discoveries, and world-firsts by taking great ideas from the lab to the market. More information can be found on the Europa EU website.

Read more about more about smart4md.

Full title: The feasibility of Fingerprick Autologous Blood (FAB) as a novel treatment for severe dry eye disease (DED): a randomised controlled trial

FAB tested the feasibility of a definitive randomised controlled trial to determine effectiveness of the use of fingerprick autologous blood compared to conventional treatment for patients with dry eye syndrome.

(DED) is an umbrella term encompassing a range of diseases estimated to affect 14% of all adults aged 48 to 91. If left untreated, DED can lead to a severe reduction in the quality of life of a sufferer and can cause loss of vision, pain in response to light, painful recurring stabbing sensations and the feeling of grit in the affected eye(s). Currently, conventional treatments for dry eyes (artificial tears, punctal plugs and anti-inflammatory drugs) often only alleviate symptoms.

Crudely, human tears with their vast constituents are essentially filtered blood, and as such are an obvious source for a "tear mimic". This study proposed to test the use of finger prick autologous blood (FAB), a technique in which a patient can simply prick their cleaned finger with a diabetic lancet and apply the fresh whole blood, with all its constituents, directly to their eye.

Trial setting, design, and methods

This was a two-centre study conducted at Bedford Hospital NHS Trust and Moorfields Eye Hospital, London.

The study recruited 60 participants with a diagnosis of severe symptomatic dry eye disease. The trial was a single-blind, two-arm, feasibility randomised controlled trial in which participants were randomised to FAB plus conventional treatment, or conventional treatment alone.

Trial objectives

To determine the feasibility of a definitive randomised controlled trial (RCT) to determine effectiveness of the use of fresh autologous blood compared to conventional treatment for patients with DED. Secondary objectives were also assessed.

Outputs

Balal, S., Udoh, A., Pappas, Y., Cook, E., Barton, G., Hassan, A., Hayden, K., Richard, R., Bourne, A., Ahmad, S., Pardhan, S., Harrison, M., Sharma, B., Wasil, M. and Sharma, A. (2018) 'The feasibility of finger prick autologous blood (FAB) as a novel treatment for severe dry eye disease (DED): protocol for a randomised controlled trial', BMJ Open, 8(10), e026770. Available at: https://doi.org/10.1136/bmjopen-2018-026770




Chief Investigator: Mr Anant Sharma (Moorfields Eye Hospital)
ARCTU involvement: Trial management; database; randomisation service
Trial sponsor and funding: Bedford Hospital NHS Trust (sponsor); NIHR RfPB (funder)
Project reference number: ClinicalTrials.gov: NCT03395431

Read more about more about fab.