Effects of Cryotherapy on Objective and Subjective Symptoms of Taxane-Induced Neuropathy in Patients With Early Breast Cancer: A National, Multicenter, Prospective, Randomized, Controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
Due to well-proven survival benefit, paclitaxel and other taxane-based chemotherapies are first-line agents for both the adjuvant and neoadjuvant treatment of early stage breast cancer. Chemotherapy-induced peripheral neuropathy (CIPN) is a frequent and disabling side effect of taxane anticancer agents. No established strategy exists for CIPN prevention. This study is designed to assess the efficacy and safety of cryotherapy for the prevention of paclitaxel-induced peripheral neuropathy in patients with breast cancer in a prospective randomized controlled trial.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
Locations
Other Locations
Denmark
Maria E Lendorf
RECRUITING
Copenhagen
Contact Information
Primary
Maria E Lendorf, MD, PhD
maria.elisabeth.lendorf.02@regionh.dk
+4526270898
Time Frame
Start Date: 2021-01-15
Estimated Completion Date: 2026-11-30
Participants
Target number of participants: 300
Treatments
Experimental: arm A - interventional
Each patient in the experimental arm will wear glycerine-containing Elasto-Gel™ gloves and socks (Elasto-Gel™ mitts for hands: TM7008, and slippers for feet: SL3000; Southwest Technologies, Inc., North Kansas City, MO, USA) over a disposable glove and sock liner secured by Velcro at the wrist and ankle on their hands and feet from 15 minutes before paclitaxel administration to 15 minutes after the infusion is complete (90 minutes in total).
No_intervention: arm B
Patients will receive planned paclitaxel chemotherapy without cryotherapy intervention.
Related Therapeutic Areas
Sponsors
Leads: Maria Lendorf
Collaborators: Nordsjaellands Hospital, Hospital of Southern Jutland, Danish Cancer Society, Aarhus University Hospital