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

NCT ID: NCT04632797

Last Updated: 2020-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

196 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-03

Study Completion Date

2024-02-03

Brief Summary

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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

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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.

Conditions

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Chemotherapy-induced Peripheral Neuropathy Chemotherapeutic Toxicity Chemotherapeutic Agent Toxicity

Keywords

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Breast Cancer Cervix Cancer Endometrium Cancer Ovarial Cancer CIPN Taxane

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

1 to 1 randomization in either cryocompression or cryotherapy of the hands
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

It is an observer blinded study.

Study Groups

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Cryocompression

Patients in this group receive cryocompression for the hands.

Group Type ACTIVE_COMPARATOR

Hilotherm Chemo Care

Intervention Type DEVICE

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

Cryotherapy

Patients in this group receive cryotherapy for the hands.

Group Type ACTIVE_COMPARATOR

Hilotherm Chemo Care

Intervention Type DEVICE

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

Interventions

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Hilotherm Chemo Care

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Medical University Innsbruck

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christine Brunner

Role: PRINCIPAL_INVESTIGATOR

Medical University Innsbruck

Locations

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Medical University Innsbruck

Innsbruck, Tyrol, Austria

Site Status RECRUITING

Countries

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Austria

Central Contacts

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Christine Brunner

Role: CONTACT

Phone: +4351250481194

Email: [email protected]

Other Identifiers

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1224/2018

Identifier Type: -

Identifier Source: org_study_id