Chemotherapeutic Agent Toxicity, Chemotherapeutic Toxicity, Chemotherapy-induced Peripheral Neuropathy
Conditions
Keywords
Breast Cancer, Cervix Cancer, Endometrium Cancer, Ovarial Cancer, CIPN, Taxane
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.
Interventions
DEVICEHilotherm Chemo Care
Application of Hilotherm Chemo Care gloves for constant cryotherapy during chemotherapy application.
Sponsors
Medical University Innsbruck
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
It is an observer blinded study.
Intervention model description
1 to 1 randomization in either cryocompression or cryotherapy of the hands
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neuro-QoL Domain for Upper Extremity (FineMotor, ADL) | 4 years | Patient-reported outcomes (PRO) |
| tuning-fork-test | 4 years | Comparison of efficacy of cryotherapy vs. cryocompression regarding occurence of ≥ CIPN III° |
| EORTC QoLCIPN20 | 4 years | Patient-reported outcomes (PRO) |
| NCV (nerve conduction velocity) | 4 years | Comparison of efficacy of cryotherapy vs. cryocompression regarding occurence of ≥ CIPN III° |
| CTCAE 4.03 | 4 years | Comparison of efficacy of cryotherapy vs. cryocompression regarding occurence of ≥ CIPN III° |
| SWME (Semmes Weinstein monofilament examination) | 4 years | Comparison of efficacy of cryotherapy vs. cryocompression regarding occurence of ≥ CIPN III° |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| time frame until polyneuopathy occurs | 4 years | time frame until polyneuopathy occurs whilst receiving Taxanes |
| National Cancer Institute Common Toxicity Criteria version 2 | 4 years | Changes of nails |
Countries
Austria
Contacts
Primary ContactChristine Brunner
Outcome results
None listed