Chemotherapy drugs, used in the treatment of cancer, have the potential of inducing peripheral neuropathy (PN) as a side effect. This side effect is commonly referred to as CIPN, or chemotherapy-induced peripheral neuropathy. The Lilac Glove and Boot devices apply a low pressure across the surface of the hands and feet, respectively, to reduce access of chemotherapy to the peripheral nerves on the hands and feet. The small amount of pressure reduces the level of chemotherapy reaching the peripheral nerves, hence increasing the likelihood of nerve preservation during treatment and thus may potentially temporarily prevent the onset of moderate to severe PN symptoms induced by chemotherapy in the hands and feet while receiving treatment
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
142
The Lilac Glove and Boot devices are wearable, non-sterile device for patients undergoing cancer treatment who wish to reduce the risk of peripheral neuropathy. Treatment with the Lilac Glove and Boot devices is administered by the healthcare professional in the healthcare environment. The Lilac Glove and Boot devices are designed for continual use; the devices must be fitted and turned on before infusion begins; the devices must be used without interruption during infusion, and for up to two (2) hours after infusion is complete.
The sham device will look, appear to function and worn for the same duration as the Lilac Device. The only difference between the devices is the level of compression applied.
Palomar Health (Topography)
Poway, California, United States
WITHDRAWNEastern Connecticut Hematology Oncology
Norwich, Connecticut, United States
RECRUITINGHialeah Hospital
Hialeah, Florida, United States
RECRUITINGHawaii Cancer Care
Honolulu, Hawaii, United States
RECRUITINGHope and Healing Cancer Services
Hinsdale, Illinois, United States
RECRUITINGParkview Cancer Institute
Fort Wayne, Indiana, United States
RECRUITINGHealth Partners Frauenshuh Cancer Center
Minneapolis, Minnesota, United States
RECRUITINGFairview Masonic Cancer Clinic, University of Minnesota
Minneapolis, Minnesota, United States
RECRUITINGAstera Cancer Care
East Brunswick, New Jersey, United States
RECRUITINGNew York Cancer and Blood Specialists
New York, New York, United States
RECRUITING...and 5 more locations
Occurrence of clinically meaningful overall CIPN symptoms at week 12 of treatment
The occurrence of clinically meaningful overall CIPN symptoms is defined as an absolute increase of 5.06 or more points over baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Chemotherapy Induced Peripheral Neuropathy-20 (EORTC QLQ-CIPN20) score (standardized 0 - 100 scale).
Time frame: From first chemotherapy and device treatment to 12 weeks post treatment one
Occurrence of clinically meaningful CIPN symptoms in the hands only at week 12 of treatment
The occurrence of clinically meaningful CIPN symptoms in the hands only is defined as an absolute increase of 9.60 or more points over baseline in the EORTC QLQ-CIPN20 upper extremity subscale score (standardized 0 - 100 scale)
Time frame: From first chemotherapy and device treatment, to 12 weeks post treatment one
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