The Lilac Device Trial for Chemotherapy-Induced Peripheral Neuropathy (CIPN)
This study is investigating if a device called The Lilac Device can help reduce nerve damage (peripheral neuropathy) caused by chemotherapy. Chemotherapy-induced peripheral neuropathy (CIPN) is a common side effect of cancer treatment. The Lilac Glove and Boot devices are worn on your hands and feet during chemotherapy to apply gentle pressure. This pressure aims to reduce the amount of chemotherapy reaching the nerves in your hands and feet, potentially preventing or lessening CIPN symptoms. Researchers will compare the Lilac Device to a sham device (which looks and feels similar but applies less compression) to see if it reduces CIPN symptoms after 12 weeks. You may be eligible if you are an adult (18+) with a solid tumor cancer, planning at least four cycles of intravenous chemotherapy.
- Study design
- This interventional study plans to enroll 142 participants. It compares the Lilac Device to a sham device.
- What's involved
- Treatment with the Lilac Glove and Boot devices is administered by a healthcare professional in a healthcare setting during your chemotherapy.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will track the occurrence of CIPN symptoms for 12 weeks after your first chemotherapy and device treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
The Lilac Device Trial - IMPACT: A Clinical Investigation on IMproving Peripheral Neuropathy Induced by Chemotherapy With Advanced Compression Technology - A Safety and Efficacy Study
At a glance
Conditions
NCT07142304
Where you'd take part
This study runs at 18 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Astera Cancer Care
East Brunswick, New Jerseystudy coordinator listed
Recruiting
Hawaii Cancer Care
Honolulu, Hawaiistudy coordinator listed
Recruiting
Health Partners Frauenshuh Cancer Center
Minneapolis, Minnesotastudy coordinator listed
Recruiting
Hialeah Hospital
Hialeah, Floridastudy coordinator listed
Recruiting
Hope and Healing Cancer Services
Hinsdale, Illinoisstudy coordinator listed
Recruiting
Hospital Sisters Health System - St.Vincent & St.Mary's
Green Bay, Wisconsinstudy coordinator listed
Recruiting
Mercy Health St. Elizabeth Hospital
Youngstown, Ohiostudy coordinator listed
Recruiting
Springfield Regional Cancer Center
Springfield, Ohiostudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
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Inclusion
What this trial measures
- Occurrence of clinically meaningful overall CIPN symptoms at week 12 of treatmentFrom 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 treatmentFrom 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)