Cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Scheduled to receive weekly paclitaxel (at 80mg/m2 via 1-hour infusion) at least 4weeks. 2. 20 years of age or over. 3. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2. 4. Patients who gave written informed consent.
Exclusion criteria
Exclusion criteria: 1. Peripheral sensory/motor neuropathy, neuralgia or edema of limb which were graded 2 or higher (CTCAE ver4.0) 2. Presence of metastasis in the bone, soft tissue or skin of the hands or foot 3. Patient with finger or toe defect 4. Not suitable for participation with Raynaud's symptoms,peripheral arterial ischemia, hand-foot syndrome, or any other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of CIPN(tactile sensation threshold) assessed at each cycle. | — |
Secondary
| Measure | Time frame |
|---|---|
| Vibration threshold Threshold of temperature perception Hand function Nerve conduction velocity Somatosensory evoked potential Current perception threshold Patient Neurotoxicity Questionnaire Acute pain Adverse events and tolerability (CIPN or other events) Discomfort with cooling (pain / paresthesia / arthritis / other) Demand of cryotherapy for both hands | — |
Countries
Japan
Contacts
Kyoto university graduate school of medicine Human Health Science