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

ConditionsCIPN - Chemotherapy-Induced Peripheral NeuropathyBreast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMaria Lendorf

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

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

    Device

    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).

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: arm A - interventionalExperimental treatment 1 intervention
Group B: arm BNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Incidence of peripheral neuropathy

CIPN is assessed using the Total Neuropathy Score reduced version (TNSr)

Time frame
CIPN is assessed 21 days after last completed cycle of paclitaxel and compared to baseline.

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Maria Lendorf

Lead sponsor

Rigshospitalet, Denmark

Sponsor institution

Danish Cancer Society

Collaborator

Aarhus University Hospital

Collaborator

Nordsjaellands Hospital

Collaborator

Hospital of Southern Jutland

Collaborator

Source ClinicalTrials.gov
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