Study Sponsor: Luminate Medical Inc.

Location: HealthPartners Cancer Center at Regions Hospital, HealthPartners Frauenshuh Cancer Center

Phase of Study: Phase III

Purpose of study: This is a double blinded device study that is looking to test the effectiveness of the medical devices being studied. The Lilac boot and glove devices function by applying a low pressure across the hands and feet to reduce the access of chemotherapy to the nerves. The study is looking to test whether this pressure helps alleviate or prevent peripheral neuropathy induced symptoms in the hands and feet while receiving chemo treatment. Double blind means you may be randomized to either the test device arm, or the placebo arm – which for this study is a “sham” device arm, and you and your care team (physician, research staff, nurses etc.) will not know whether you are receiving the test device or the “sham” device. The test device and “sham” device look exactly identical, but differ in the amount of pressure they emit.

Inclusion Criteria: 

– Must be at least 18 years or older

– Diagnosed with solid tumor cancer and be deemed appropriate for adjuvant or neo-adjuvant chemotherapy.

– Must have a planned 12 weeks of chemo treatment, with no treatment pause for surgery during the treatment period, with a specific chemotherapy regimen. (Several regimen options exist that are allowed for this study, so discuss with your physician if the planned regimen would allow you to take part in the study).

– Hands and feet must fit within the study specified sizing range to ensure they fit in the glove and boot devices.

– ECOG of 0 – 2.

– Must be willing to comply with study visit timeline and wear the Lilac glove and boot devices for the duration of the chemotherapy administration, and for 2 hours after the administration is completed.

– Must be willing to complete study-related questionnaires.

Additional criteria may apply and should be discussed with the research team and physician.

 

Exclusion Criteria:

– Has a baseline neuropathy of any kind.

– Prior exposure to neurotoxic chemo in the last year.

– Positive pregnancy test at baseline.

– Any known allergic reaction to device materials. (Rubber, latex, etc.)

– Open wounds, sores, cysts, or injury on the participant’s hands or feet where the device will be applied.

– Has untreated hypertension.

– Has poorly controlled diabetes.

– Is using other devices or compression methods to prevent chemo-induced neuropathy symptoms while on trial.

– Is receiving Pregabalin, Gabapentin, Amitriptyline, Nortriptyline, Venlafaxine, or Duloxetine.

Additional exclusion criteria may apply and should be discussed with the research team and physician.

 

Study Contact:
Alissa Gavenda
(952) 993-6705
alissa.gavenda@parknicollet.com

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