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

Not Applicable

• Conditions: Chemotherapy-induced Peripheral Neuropathy; Chemotherapeutic Agent Toxicity; Chemotherapeutic Toxicity
• Interventions: Device: Hilotherm Chemo Care

• Registration Number: NCT04632797
• Lead Sponsor: Medical University Innsbruck

Brief Summary

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.

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 Timeline

• Status Verified: 2020-02
• Study Start: 2020-02-03
• Study First Submitted: 2020-10-21
• Study First Submitted QC: 2020-11-16
• Last Update Submitted: 2020-11-16
• Study First Posted: 2020-11-17
• Last Update Posted: 2020-11-17
• Primary Completion: 2022-02-03
• Study Completion: 2024-02-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 196

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cryotherapy	Hilotherm Chemo Care	Patients in this group receive cryotherapy for the hands.
Cryocompression	Hilotherm Chemo Care	Patients in this group receive cryocompression for the hands.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
National Cancer Institute Common Toxicity Criteria version 2	4 years	Changes of nails
time frame until polyneuopathy occurs	4 years	time frame until polyneuopathy occurs whilst receiving Taxanes

Trial Locations

Locations (1)

Medical University Innsbruck; 🇦🇹 Innsbruck, Tirol, Austria