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

Medical University Innsbruck

Status: Unknown

Conditions: Chemotherapeutic Agent Toxicity; Chemotherapy-induced Peripheral Neuropathy; Chemotherapeutic Toxicity

Treatments: Device: Hilotherm Chemo Care

Study type: Interventional

Funder types: Other

Identifiers

NCT04632797

1224/2018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 196 estimated patients

Sex: Female

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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196 participants in 2 patient groups

Cryocompression

Active Comparator group

Description:

Patients in this group receive cryocompression for the hands.

Treatment:

Device: Hilotherm Chemo Care

Cryotherapy

Active Comparator group

Description:

Patients in this group receive cryotherapy for the hands.

Treatment:

Device: Hilotherm Chemo Care