Preventive effect of frozen glove for docetaxel-induced nail toxicities in advanced breast cancer patients

UMIN ID: UMIN000000478

Registered date:11/09/2006

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Breast cancer
• Date of first enrollment: 2006/12/01
• Target sample size: 25
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Simpler freezing method and shorter administration of frozen glove in experimental side (hand)

Outcome(s)

• Primary Outcome: Occurrence of any nail toxicities at 4 months of Docetaxel infusion
• Secondary Outcome: Occurrence of any grade 2 or higher nail toxicities at 4 months of Docetaxel infusion Time (and total number or amount of Docetaxel administration) until first occurrence of any Docetaxel-induced nail toxicities Detail classification of grade 2 or higher nail toxicities Degree of un-comfort by the use of frozen glove

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 69years-old
• Gender: Female
• Exclude criteria: Infection, Fever = or > 38C Serious comorbidity Interstitial pneumonitis/fibrosis Peripheral neuropathy/edema Raynaud symptom/peripheral arterial disease Finger skin/bone/soft tissue metastasis Positive HBsAg Apparent nail adverse effect Decision by primary physician

Related Information

• Primary Sponsor: Outpatient Oncology Unit Kyoto University Hospital
• Source(s) of Monetary Support: none
• Secondary ID(s): C79,TCO-0604