Verification of the preventive effect for vincristin-induced peripheral neuropathy by frozen gloves and socks

UMIN ID: UMIN000017815

Registered date:08/06/2015

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Cancer
• Date of first enrollment: 2015/06/08
• Target sample size: 10
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): All patients wear frozen glove and socks on either side of hand and foot.

Outcome(s)

• Primary Outcome: Incidence of chemotherapy-induced peripheral neuropathy assessed at each cycle
• Secondary Outcome: FACT/GOG-NTx(patient questionnaire) Tolerability of frozen gloves and socks Skin toxicity

Key inclusion & exclusion criteria

• Age minimum: 15years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1) Drug allergy that might interfere with this drug, patients with cold allergy and its history. 2)Patients with any of the grade two or more of peripheral neuropathy or limb edema in the registration time. 3)Patients with metastatic tumor found in (sub)cutaneous lesion. 4) Patients with Raynaud's symptoms, peripheral arterial ischemia symptoms, hand-foot syndrome, or injury in the hands or feet, and patients the doctor has determined inadequate for this study. 5) Patients with demyelinating Charcot-Marie-Tooth disease. 6) Patients with pregnancy or breast-feeding.

Related Information

• Primary Sponsor: Nagoya City University Hospital,Division of Chemotherapy
• Source(s) of Monetary Support: Kidani Memorial Trust,Aichi Nursing Association