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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05928429
• Other study ID #: CryoPac
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2021
• Est. completion date: November 30, 2026

Study information

• Verified date: June 2023
• Source: Rigshospitalet, Denmark
• Contact: Maria E Lendorf, MD, PhD
• Phone: +4526270898
• Email: maria.elisabeth.lendorf.02[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

BACKGROUND: 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.

OBJECTIVES:

Primary objective: To assess the efficacy of cryotherapy to prevent paclitaxel chemotherapy induced peripheral neuropathy (CIPN) Secondary objective: To search for risk factors for CIPN. METHOD Study Design: A national, multicenter, interventional, randomized, non-blinded clinical trial evaluating the preventive effects of cryotherapy for CIPN.

Eligibility: Key inclusion criteria; Patients with early breast cancer scheduled to receive weekly paclitaxel (80mg/m2 for one hour) 9 doses, PS 0-1.

Sample size: 300 Randomization: Participants will be randomized 1:1 to A: use of Elasto-Gel™ frozen glove and sock on their hands and feet during paclitaxel treatment or B: standard treatment. Randomization will be performed in REDCap using the Electronic Case Report Forms (eCRFs).

Cryotherapy Intervention: 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).

Primary outcomes: Incidence of peripheral neuropathy; CIPN is assessed using the Total Neuropathy Score reduced version (TNSr) 21 days after last completed cycle of paclitaxel and compared to baseline.

Key secondary outcomes: Objective symptoms - Quantitative sensory testing (QST).

Subjective symptoms - Patient Reported Outcome: (EORTC Quality of Life Questionnaire (QLQ)-C30 and EORTC (QLQ)-CIPN20), pain and tolerability etc.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: November 30, 2026
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• CIPN - Chemotherapy-Induced Peripheral Neuropathy
• Peripheral Nervous System Diseases

Intervention

Device:
• Elasto-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

Country	Name	City	State
Denmark	Maria E Lendorf	Copenhagen

Sponsors (5)

Lead Sponsor	Collaborator
Maria Lendorf	Aarhus University Hospital, Danish Cancer Society, Hospital of Southern Jutland, Nordsjællands Hospital, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.