RecruitingNot ApplicableNCT05928429

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

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


Sponsor

Maria Lendorf

Enrollment

300 participants

Start Date

Jan 15, 2021

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether using cold therapy (cryotherapy — like cooling gloves or socks) during weekly paclitaxel chemotherapy infusions can prevent or reduce nerve damage (tingling, numbness, or pain in the hands and feet) that this drug commonly causes. **You may be eligible if...** - You have early-stage breast cancer - You are scheduled to receive weekly paclitaxel chemotherapy (12 or 9 doses at 80mg/m²) - Your general health (performance status) is 0 or 1 **You may NOT be eligible if...** - You already have nerve damage (neuropathy, pain, or swelling) in your limbs at grade 2 or higher - You have Raynaud's syndrome (a condition where cold causes blood vessel spasms) - You have peripheral arterial ischemia (reduced blood flow to the limbs) - Your doctor determines that cold therapy is not safe for another medical reason Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEElasto-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).


Locations(1)

Maria E Lendorf

Copenhagen, Denmark

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NCT05928429


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