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

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ClinicalTrials.gov Identifier: NCT05928429
Recruitment Status : Recruiting
First Posted : July 3, 2023
Last Update Posted : July 3, 2023
Sponsor:
Collaborators:
Danish Cancer Society
Aarhus University Hospital
Nordsjællands Hospital, Denmark
Hospital of Southern Jutland
Information provided by (Responsible Party):
Maria Lendorf, Rigshospitalet, Denmark

Study Description
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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.

Condition or disease Intervention/treatment Phase
CIPN - Chemotherapy-Induced Peripheral Neuropathy Breast Cancer Device: Elasto-Gel™ mitts for hands: TM7008, and slippers for feet: SL3000; Southwest Technologies, Inc., North Kansas City, MO, USA Not Applicable

Detailed 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: A national, multicenter, interventional, randomized, non-blinded clinical trial evaluating the preventive effects of cryotherapy for CIPN.
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : January 15, 2021
Estimated Primary Completion Date : November 30, 2023
Estimated Study Completion Date : November 30, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: arm A - interventional
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
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).
No Intervention: arm B
Patients will receive planned paclitaxel chemotherapy without cryotherapy intervention.


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of peripheral neuropathy [ Time Frame: CIPN is assessed 21 days after last completed cycle of paclitaxel and compared to baseline. ]
    CIPN is assessed using the Total Neuropathy Score reduced version (TNSr)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05928429


Contacts
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Contact: Maria E Lendorf, MD, PhD +4526270898 maria.elisabeth.lendorf.02@regionh.dk

Locations
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Denmark
Maria E Lendorf Recruiting
Copenhagen, Denmark, 2100
Contact: Maria E Lendorf    +4526270898    maria.elisabeth.lendorf.02@regionh.dk   
Sponsors and Collaborators
Maria Lendorf
Danish Cancer Society
Aarhus University Hospital
Nordsjællands Hospital, Denmark
Hospital of Southern Jutland
More Information
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Responsible Party: Maria Lendorf, MD, PhD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT05928429    
Other Study ID Numbers: CryoPac
First Posted: July 3, 2023    Key Record Dates
Last Update Posted: July 3, 2023
Last Verified: June 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Peripheral Nervous System Diseases
Neoplasms by Site
Neoplasms
 Breast Diseases
Skin Diseases
Neuromuscular Diseases
Nervous System Diseases