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

Chemotherapy-induced Peripheral Neuropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04632797
• Other study ID #: 1224/2018
• Status: Recruiting
• Phase: N/A
• Start date: February 3, 2020
• Est. completion date: February 3, 2024

Study information

• Verified date: February 2020
• Source: Medical University Innsbruck
• Contact: Christine Brunner
• Phone: +4351250481194
• Email: c.brunner[@]tirol-kliniken.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 196
• Est. completion date: February 3, 2024
• Est. primary completion date: February 3, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Chemotherapeutic Agent Toxicity
• Chemotherapeutic Toxicity
• Chemotherapy-induced Peripheral Neuropathy
• Peripheral Nervous System Diseases

Intervention

Device:
• Hilotherm Chemo Care
Application of Hilotherm Chemo Care gloves for constant cryotherapy during chemotherapy application.

Locations

Country	Name	City	State
Austria	Medical University Innsbruck	Innsbruck	Tirol

Sponsors (1)

Lead Sponsor	Collaborator
Medical University Innsbruck

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NCV (nerve conduction velocity)	Comparison of efficacy of cryotherapy vs. cryocompression regarding occurence of = CIPN III°	4 years
Primary	CTCAE 4.03	Comparison of efficacy of cryotherapy vs. cryocompression regarding occurence of = CIPN III°	4 years
Primary	SWME (Semmes Weinstein monofilament examination)	Comparison of efficacy of cryotherapy vs. cryocompression regarding occurence of = CIPN III°	4 years
Primary	tuning-fork-test	Comparison of efficacy of cryotherapy vs. cryocompression regarding occurence of = CIPN III°	4 years
Primary	EORTC QoLCIPN20	Patient-reported outcomes (PRO)	4 years
Primary	Neuro-QoL Domain for Upper Extremity (FineMotor, ADL)	Patient-reported outcomes (PRO)	4 years
Secondary	National Cancer Institute Common Toxicity Criteria version 2	Changes of nails	4 years
Secondary	time frame until polyneuopathy occurs	time frame until polyneuopathy occurs whilst receiving Taxanes	4 years