Using cryotherapy to prevent nerve damage from breast cancer chemotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness and safety of cryotherapy in preventing chemotherapy-induced peripheral neuropathy (CIPN) in patients with early-stage breast cancer receiving paclitaxel. Participants will be randomly assigned to either receive cryotherapy using Elasto-Gel™ gloves and socks during treatment or standard care. The study aims to evaluate the efficacy of this intervention and identify potential risk factors for developing CIPN. It is a multicenter, randomized, non-blinded trial involving 300 patients across various locations.

Why it matters

Who can join: the full rules

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.

Where it's running

• Maria E Lendorf
  Copenhagen, Denmark Recruiting

Study contacts

• Study coordinator: Maria E Lendorf, MD, PhD
• Email: maria.elisabeth.lendorf.02@regionh.dk
• Phone: +4526270898

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.