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

NCT05928429 | Recruiting

• 1 other identifier: CryoPac
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

CIPN - Chemotherapy-Induced Peripheral Neuropathy; Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Incidence of peripheral neuropathy

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

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

Study Arms (2)

arm A - interventional

EXPERIMENTAL

Each patient 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).

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

arm B

NO INTERVENTION

Patients will receive planned paclitaxel chemotherapy without cryotherapy intervention.

Interventions

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).

arm A - interventional

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maria Lendorf: lead
• Danish Cancer Society: collaborator
• Aarhus University Hospital: collaborator
• Nordsjaellands Hospital: collaborator
• Hospital of Southern Jutland: collaborator

Study Sites (1)

Maria E Lendorf

Copenhagen, 2100, Denmark

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Maria E Lendorf, MD, PhD

CONTACT

+4526270898; maria.elisabeth.lendorf.02@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD

Model Details: A national, multicenter, interventional, randomized, non-blinded clinical trial evaluating the preventive effects of cryotherapy for CIPN.

Study Record Dates

• First Submitted: June 23, 2023
• First Posted: July 3, 2023
• Study Start: January 15, 2021
• Primary Completion: November 30, 2023
• Study Completion (Estimated): November 30, 2026
• Last Updated: July 3, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)