Effects of Cryotherapy on Taxane-Induced Neuropathy in Patients With Breast Cancer

Condition(s) studied

Investigational drug(s) / intervention(s)

Elasto-Gel™ mitts for hands: TM7008, and slippers for feet: SL3000; Southwest Technologies, Inc., North Kansas City, MO, USA: Patients 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).

Study 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

Primary outcome measure(s)

• Incidence of peripheral neuropathy — CIPN is assessed 21 days after last completed cycle of paclitaxel and compared to baseline.
  CIPN is assessed using the Total Neuropathy Score reduced version (TNSr)

Trial sites (1)

Other trials for the same condition