SenseCheQ: Community-based sensory testing for early identification of Chemotherapy Induced Peripheral Neuropathy.

Chemotherapy is an important treatment for cancer. Unfortunately, it also causes side effects, including chronic pain and changes in the sense of touch. This is due to nerve damage. In up to 1 in 3 people, these changes last longer than 6 months, causing misery, disability and adding to the burden of cancer survivorship.

These changes are vague to begin with, yet early detection is important, as reducing the chemotherapy dose is the only way to reduce the severity of symptoms. Reducing the dose, however, must be balanced against the possible risk of the treatment being less successful. This highlights how important it is to detect these signs early and accurately.

One way of detecting these changes is with careful testing of the skin's senses. This is achieved by asking patients when they feel small changes in temperature or vibrations and then comparing that to readings taken before chemotherapy was started. Such tests are well known in the pain research community where they are called Quantitative Sensory Testing (QST). Frustratingly, QST takes a long time to perform, is expensive and needs the patients to keep coming into clinic during a very vulnerable time in their cancer treatment. These issues mean that this formal QST is not suitable for routine clinical use.

Our team of patients, pain doctors and engineers believe that we can deliver a simple, cheap and effective sense testing kit, that we are calling SenseCheQ. This will enable patients to check the health of their nerves, at home, during their chemotherapy. We will design SenseCHeQ to be sensitive enough to detect early changes, potentially before the patient notices any symptoms, to enable personalised treatments that will maximise the success of cancer treatment, whilst minimising the risk of chronic pain and loss of sensation.

To deliver SenseCheQ we need to complete four complementary workplans.

Workplan 1 (UK wide) will be led and driven by patient partners to ensure that SenseCHeQ is user friendly and meets the needs of patients. This workplan will also feed into the remaining workplans to ensure that patients remain at the centre of our focus.

Workplan 2 (Newcastle) will engineer solutions, by identifying and integrating off-the-shelf components into suitable 'wearables' and providing power and communications.

Workplan 3 (Bristol) will test these solutions in healthy volunteers. Initially, individual components will be tested alone and compared to commonly used sensory testing equipment. As designs progress, through testing and re-design cycles working closely with WP1 and WP2, this workplan will move to validating early SenseCHeQ versions in models of nerve damage, which will cause temporary numbness or pain, again in healthy volunteers.

Workplan 4 (Dundee) will perform a feasibility study in patients. Workplan 4 will synergise with PAINSTORM, another Versus/MRC advanced pain discovery platform program of work that is seeking to harmonise assessment of pain caused by nerve damage, not just damage caused by chemotherapy. PAINSTORM are funded to perform QST on patients as they move through their chemotherapy. We will ask some of these patients to use SenseCHeQ at home at the same time. We will be most interested in how patients get on with the device - is it easy to use? Robust? We will also compare SenseCHeQ to the QST results to estimate its ability to detect early neuropathy.

If successful, we will apply for further funding to confirm these findings and thus move SenseCHeQ towards a clinically useful tool empowering patients to monitor their own nerve health, at home, minimise their risks of developing chronic pain and numbness and enabling delivery of truly personalised cancer treatment.

Chemotherapy induced peripheral neuropathy (CIPN) affects 30% of patients receiving chemotherapy to treat cancer. CIPN presents with numbness and pain in a glove and stocking distribution. There is no effective preventative or therapeutic treatment, and the only mitigation is chemotherapy dose reduction/switching, which is a difficult clinical decision.

Detection of CIPN relies on patient report and clinical examination which lacks sensitivity in early CIPN. Quantitative Sensory Testing (QST) is the 'gold standard' assessment of sensory function but it is not in routine clinical use for pragmatic reasons. To enable early detection of CIPN we propose to develop an easy-to-use sensory testing device "SenseCheQ" to allow patients to monitor their nerve health at home. This will provide early, accurate assessment of sensory function to detect nerve damage and potentially avoid chronic neuropathic pain.

This will be achieved with iterative and modular device development cycles through collaboration with bio-electronic engineers and patient partners. SenseCheQ will safely deliver automated QST protocols (warmth detection, cool detection and vibration detection), with simplified data capture and be able to transmit that information remotely.

This project will synergise with the APDP PAINSTORM consortium, who will prospectively recruit a cohort of patients due to undergo chemotherapy. This cohort will undergo formal QST during their treatment as well as clinical monitoring. A subgroup of these patients (n=20) will have home QST with the SenseCheQ, within a feasibility study, with measures obtained before treatment starts and at intervals during their chemotherapy. This parallel collection of QST data will enable direct comparison of the device with clinical sensory phenotyping.

The project maps the path for delivery of a novel device capable of giving patients and clinicians better and earlier information to optimise and personalise their cancer treatment.