The Lilac Device Trial - IMPACT: A Clinical Investigation on IMproving Peripheral Neuropathy Induced by Chemotherapy With Advanced Compression Technology - A Safety and Efficacy Study
Condition(s) studied
Investigational drug(s) / intervention(s)
The Lilac Device: 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.
Sham device: 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.
Study summary
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
Eligibility
Primary outcome measure(s)
- Occurrence of clinically meaningful overall CIPN symptoms at week 12 of treatment — From first chemotherapy and device treatment to 12 weeks post treatment one
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). - Occurrence of clinically meaningful CIPN symptoms in the hands only at week 12 of treatment — From first chemotherapy and device treatment, to 12 weeks post treatment one
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)
Trial sites (18)
| Facility | City | Region | Status |
|---|---|---|---|
| Palomar Health (Topography) | Poway | California | Withdrawn |
| Eastern Connecticut Hematology Oncology | Norwich | Connecticut | Recruiting |
| Hialeah Hospital | Hialeah | Florida | Recruiting |
| Hawaii Cancer Care | Honolulu | Hawaii | Recruiting |
| Hope and Healing Cancer Services | Hinsdale | Illinois | Recruiting |
| Parkview Cancer Institute | Fort Wayne | Indiana | Recruiting |
| Health Partners Frauenshuh Cancer Center | Minneapolis | Minnesota | Recruiting |
| Fairview Masonic Cancer Clinic, University of Minnesota | Minneapolis | Minnesota | Recruiting |
| Astera Cancer Care | East Brunswick | New Jersey | Recruiting |
| Inspira Medical Center Mullica Hill | Mullica Hill | New Jersey | Recruiting |
| Inspira Health - Vineland | Vineland | New Jersey | Recruiting |
| New York Cancer and Blood Specialists | New York | New York | Recruiting |
| Springfield Regional Cancer Center | Springfield | Ohio | Recruiting |
| Mercy Health St. Elizabeth Hospital | Youngstown | Ohio | Recruiting |
| Providence Cancer Institute | Portland | Oregon | Recruiting |
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | Recruiting |
| Hospital Sisters Health System - St.Vincent & St.Mary's | Green Bay | Wisconsin | Recruiting |
| St. James Hospital | Dublin | Dublin | Recruiting |
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07142304 on ClinicalTrials.gov ↗ ← All trials in Ireland