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.

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.

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