Cryotherapy vs. Cryocompression for Preventing Chemotherapy-induced-peripheral-neuropathy in Women Undergoing Chemotherapy

CROPSI Study A Randomized, Observer-blinded Clinical Trial Evaluating Effectiveness of Cryotherapy vs. Cryocompression for Preventing CIPN in Women Undergoing Chemotherapy

This study's aim is to show a benefit of Cryocompression (cooling hands with additional compression of the hands) in comparison to Cryotherapy (just cooling hands) in female cancer patients (with gynecological cancer) receiving chemotherapy with taxanes.

Patients who are not eligible for either cryocompression or cryotherapy are included in a control group.

The expected benefits with additional compression to the cryotherapy are reduction of chemotherapy induced polyneuropathy and reduced nail changes.

Study Overview

• Status: Recruiting
• Conditions: Chemotherapeutic Toxicity; Chemotherapy-induced Peripheral Neuropathy; Chemotherapeutic Agent Toxicity
• Intervention / Treatment: Device: Hilotherm Chemo Care

Detailed Description

In this randomized, observer blinded, monocentric study 196 patients will be included in a four years period.

The patients will be 1 to 1 randomized in either cryocompression or cryotherapy. Patients who are not eligible for either cryocompression or cryotherapy will be included in the control group.

Additionally every patient (excluding the control group) receives cryotherapy for the feet.

Before receiving the first chemotherapy CTCAE, Semmes-Weinstein monofilament examination (SWME), vibration test for hand and feet, and nerve conduction velocity (NCV) only for hands.

• Study Type: Interventional
• Enrollment (Anticipated): 196
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christine Brunner; Phone Number: +4351250481194; Email: c.brunner@tirol-kliniken.at

Study Locations

• Austria
  • Tirol
    • Innsbruck, Tirol, Austria, 6020
      • Recruiting
      • Medical University Innsbruck

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Patients with breast cancer or other gynecological tumors
• planned neoadjuvant, adjuvant or palliative chemotherapy
• </= two lines chemotherapy as pre-therapy (adjuvant chemotherapy counts as one line)
• at least three cycles of chemotherapy with taxanes
• written consent
• 18 years and older

Exclusion Criteria:

• PNP >/= 2
• neuralgia
• metastases in bones, metastases in soft tissue (located in skin, hands or feet)
• Raynaud syndrome
• peripheral arterial ischemia
• hand-feet syndrome

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cryocompression; Patients in this group receive cryocompression for the hands.	Device: Hilotherm Chemo Care; Application of Hilotherm Chemo Care gloves for constant cryotherapy during chemotherapy application.
Active Comparator: Cryotherapy; Patients in this group receive cryotherapy for the hands.	Device: Hilotherm Chemo Care; Application of Hilotherm Chemo Care gloves for constant cryotherapy during chemotherapy application.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NCV (nerve conduction velocity)	Comparison of efficacy of cryotherapy vs. cryocompression regarding occurence of ≥ CIPN III°	4 years
CTCAE 4.03	Comparison of efficacy of cryotherapy vs. cryocompression regarding occurence of ≥ CIPN III°	4 years
SWME (Semmes Weinstein monofilament examination)	Comparison of efficacy of cryotherapy vs. cryocompression regarding occurence of ≥ CIPN III°	4 years
tuning-fork-test	Comparison of efficacy of cryotherapy vs. cryocompression regarding occurence of ≥ CIPN III°	4 years
EORTC QoLCIPN20	Patient-reported outcomes (PRO)	4 years
Neuro-QoL Domain for Upper Extremity (FineMotor, ADL)	Patient-reported outcomes (PRO)	4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
National Cancer Institute Common Toxicity Criteria version 2	Changes of nails	4 years
time frame until polyneuopathy occurs	time frame until polyneuopathy occurs whilst receiving Taxanes	4 years

Collaborators and Investigators

• Sponsor: Medical University Innsbruck
• Investigators: Principal Investigator: Christine Brunner, Medical University Innsbruck

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2020
• Primary Completion (Anticipated): February 3, 2022
• Study Completion (Anticipated): February 3, 2024

Study Registration Dates

• First Submitted: October 21, 2020
• First Submitted That Met QC Criteria: November 16, 2020
• First Posted (Actual): November 17, 2020

Study Record Updates

• Last Update Posted (Actual): November 17, 2020
• Last Update Submitted That Met QC Criteria: November 16, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Breast Cancer; Cervix Cancer; Endometrium Cancer; CIPN; Taxane; Ovarial Cancer
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases
• Other Study ID Numbers: 1224/2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No