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Trial Title:
Effects of Cryotherapy on Taxane-Induced Neuropathy in Patients With Breast Cancer
NCT ID:
NCT05928429
Condition:
CIPN - Chemotherapy-Induced Peripheral Neuropathy
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Peripheral Nervous System Diseases
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
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.
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Elasto-Gel™ mitts for hands: TM7008, and slippers for feet: SL3000; Southwest Technologies, Inc., North Kansas City, MO, USA
Description:
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 group label:
arm A - interventional
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.
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.
Criteria for eligibility:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Maria E Lendorf
Address:
City:
Copenhagen
Zip:
2100
Country:
Denmark
Status:
Recruiting
Contact:
Last name:
Maria E Lendorf
Phone:
+4526270898
Email:
maria.elisabeth.lendorf.02@regionh.dk
Start date:
January 15, 2021
Completion date:
November 30, 2026
Lead sponsor:
Agency:
Maria Lendorf
Agency class:
Other
Collaborator:
Agency:
Danish Cancer Society
Agency class:
Other
Collaborator:
Agency:
Aarhus University Hospital
Agency class:
Other
Collaborator:
Agency:
Nordsjællands Hospital, Denmark
Agency class:
Other
Collaborator:
Agency:
Hospital of Southern Jutland
Agency class:
Other
Source:
Rigshospitalet, Denmark
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05928429
