Highly-efficient and miniaturised cooling-compression technology aims to prevent/reduce pain and sensitivity in hands and feet due to chemotherapy
A team of clinicians and scientists from the National University Cancer Institute, Singapore (NCIS) at the National University Hospital (NUH) and the N.1 Institute for Health at the National University of Singapore (NUS) has partnered Paxman Coolers Ltd (UK) (Paxman) to develop a device that may prevent or reduce numbness and pain caused by certain types of anti-cancer therapy¹. Chemotherapy-induced peripheral neuropathy (CIPN) is a severe side-effect of chemotherapy drugs called taxanes, which are used to treat common cancers such as breast, lung, ovarian and stomach cancer. CIPN affects about 1.4 million cancer patients globally every year².
CIPN causes progressive and often irreversible pain or sensitivity in the hands and feet of patients undergoing chemotherapy leading to delays and discontinuation of treatment. It contributes to long-term poor patient well-being and significantly increases economic burden in terms of healthcare costs. The condition also leads to loss in work productivity, as affected patients are unable to return to work quickly.
Unmet clinical need
Few to no prevention and treatment strategies exist for CIPN. Recently, cryotherapy (or cooling) of the limbs during chemotherapy has demonstrated a protective effect by preventing/reducing CIPN severity. However, the currently used frozen gloves or ice packs are not user-friendly, deliver unstable cooling and can cause severe frostbite. There is a need for a medical device developed for patients’ use in a chemo suite and which can deliver stable cooling, tolerable over the entire duration of the chemotherapy.
A novel solution for CIPN
In collaboration with Paxman, the Singapore research team from NUHS comprising clinicians and researchers from the Department of Haematology-Oncology at NCIS and NUH, and the N.1 Institute for Health at NUS are developing a portable limb cryocompression device specifically targeting prevention of CIPN in cancer patients. The team has studied various proof of concept aspects of the cryocompression technology, over the past eight years³, previously supported by the National Health Innovation Centre Singapore (NHIC) through its Innovation to Develop grant. Working together as a team since 2019, Paxman, global leaders in scalp cooling for prevention of chemo-induced hair loss, was identified as the ideal commercialisation partner for the project.
The research team has been awarded a translational grant from the National Research Foundation (NRF) Central Gap Fund in May 2021, which will be administered by NHIC. Pilot studies will commence in Q2 2022 to investigate the device in healthy volunteers, and cancer patients undergoing CIPN-causing chemotherapy. The efficacy of prevention will be monitored using various clinical and patient-reported outcomes.
Principal Investigator Assistant Professor Raghav Sundar, Consultant at the Department of Haematology-Oncology at the National University Cancer Institute, Singapore (NCIS) and Investigator at The N.1 Institute for Health at NUS, said, “This collaboration will have a significant and broad impact. By preventing or reducing CIPN, the overall health and quality of life of cancer patients will be significantly enhanced, during and after chemotherapy. The treatment of CIPN is an unmet and increasingly urgent clinical need, and a preventative solution will hopefully improve patient quality-of-life.”
Co-Principal Investigator Dr Aishwarya Bandla, Head of Translational Tx Core at The NUS N.1 Institute for Health, added, “This international multidisciplinary collaboration brings together complementary cross-sector expertise from the hospital, academia, and industry. The overall product-development process will utilise a patient-centered approach, placing the patients’ safety and efficacy at the heart of the design process.”
“This funding is a testimony to the high impact the new product will have on the quality of life for cancer patients receiving taxane-based therapies, not only in Singapore, but throughout the world. It will allow our collaborative team, not only to crucially accelerate the research and development process but will also significantly de-risk the project from a commercial perspective,” commented Mr Richard Paxman, CEO of Paxman.
“Paxman is determined, not only to provide patient access to scalp cooling technology to prevent chemotherapy-induced hair loss globally, but now also to give patients the chance to reduce or prevent the debilitating side effect of peripheral neuropathy. We bring to this collaboration extensive expertise in design, development, manufacture, regulatory approval, along with experience of commercialising medical cooling devices. The company is perfectly placed to roll out this technology to its existing and growing customer base throughout the world.”
(1). J Binder, E Unver, J Clayton, P Burke, R Paxman, R Sundar, A Bandla. A Limb Hypothermia Wearable for Chemotherapy-Induced Peripheral Neuropathy: A Mixed-Methods Approach in Medical Product Development. Frontiers in Digital Health. Published: 15 Dec 2020.
(2). Charles L Loprinzi, Christina Lacchetti, Jonathan Bleeker, et al. Prevention and Management of Chemotherapy-Induced Peripheral Neuropathy in Survivors of Adult Cancers: ASCO Guideline Update. Journal of Clinical Oncology. Published: 1 Oct 2020, E-published: 14 Jul 2020.
(3)(i). Bandla A, Tan S, Kumarakulasinghe NB, Huang Y, Ang S, Magarajah G, Hairom Z, Lim JSJ, Wong A, Chan G, Ngoi N, Ang E, Lee YM, Chan A, Lee SC, Thakor N, Wilder-Smith E, Sundar R. Safety and tolerability of cryocompression as a method of enhanced limb hypothermia to reduce taxane-induced peripheral neuropathy. Support Care Cancer. Published: August 2020. E-published: 6 December 2019
(ii). Sundar R, Bandla A, Tan SS, Liao LD, Kumarakulasinghe NB, Jeyasekharan AD, Ow SG, Ho J, Tan DS, Lim JS, Vijayan J, Therimadasamy AK, Hairom Z, Ang E, Ang S, Thakor NV, Lee SC, Wilder-Smith EP. Limb Hypothermia for Preventing Paclitaxel-Induced Peripheral Neuropathy in Breast Cancer Patients: A Pilot Study. Frontiers in Oncology. Published: 10 January 2017
(iii). Bandla A, Sundar R, Liao LD, Sze Hui Tan S, Lee SC, Thakor NV, Wilder-Smith EP. Hypothermia for preventing chemotherapy-induced neuropathy – a pilot study on safety and tolerability in healthy controls. Acta Oncologica. E-published: 11 September 2015.