Clinical trial NCT04632797: Cryotherapy vs. Cryocompression for Preventing Chemotherapy-induced-peripheral-neuropathy in Women Undergoing Chemotherapy
Official title: CROPSI Study A Randomized, Observer-blinded Clinical Trial Evaluating Effectiveness of Cryotherapy vs. Cryocompression for Preventing CIPN in Women Undergoing Chemotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chemotherapy-induced Peripheral Neuropathy
Chemotherapeutic Toxicity
Chemotherapeutic Agent Toxicity
Keywords: Breast Cancer
Cervix Cancer
Endometrium Cancer
Ovarial Cancer
CIPN
Taxane
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
First posted: 2020-11-17
Enrollment: 196
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1 to 1 randomization in either cryocompression or cryotherapy of the hands
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: NCV (nerve conduction velocity)
timeFrame: 4 years
measure: CTCAE 4.03
timeFrame: 4 years
measure: SWME (Semmes Weinstein monofilament examination)
timeFrame: 4 years
measure: tuning-fork-test
timeFrame: 4 years
measure: EORTC QoLCIPN20
timeFrame: 4 years
measure: Neuro-QoL Domain for Upper Extremity (FineMotor, ADL)
timeFrame: 4 years
Secondary outcomes:
measure: National Cancer Institute Common Toxicity Criteria version 2
timeFrame: 4 years
measure: time frame until polyneuopathy occurs
timeFrame: 4 years
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Medical University Innsbruck
state: Tirol
Study officials:
affiliation: Medical University Innsbruck
name: Christine Brunner
role: PRINCIPAL_INVESTIGATOR
References: