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

RecruitingNAAges 18 Years - anyAllMaria Lendorf
NCT05928429 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: Key inclusion criteria; Patients with early breast cancer scheduled to receive weekly paclitaxel (80mg/m2 for one hour) 9 or 12 doses, PS 0-1 Exclusion Criteria: Peripheral sensory/motor neuropathy, neuralgia or edema of the limb graded \>=2 (CTCAE ver 5.0), Patient with Raynaud's symptoms; peripheral arterial ischemia; or any other reasons based on the primary physician's judgment.
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What it tests

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

1 site
Maria E Lendorf
Copenhagen, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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