NIPH Clinical Trials Search

UMIN ID: UMIN000000806

Registered date:01/09/2007

Multicenter phase II trial to Prevent Docetaxel-Induced Nail change using a Frozen Glove with docetaxel (T) and cyclophosphamide(C) as adjuvant chemotherapy for patients with high risk, node negative, early stage breast cancer: Tokai Breast Cancer Clinical Research Group (TBCRG) 03 trial

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedBreast cancer
Date of first enrollment2007/07/01
Target sample size50
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Frozen glove to prevent docetaxel-induced nail toxicities with right hand. Docetaxel 75 mg/m2 IV Day 1Cyclophosphamide 600 mg/m2 IV Day 1 Every 21 days X 4 CyclesUse standard premedication


Primary OutcomePrevention of nail change by frozen glove
Secondary OutcomeSafety, feasibility

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum70years-old
Include criteria
Exclude criteria1.As neoadjuvant and adjuvant therapy , treated hormone therapy and chemotherapy 2.HER2 / neu gene overexpressed or amplified 3.A history of whitlow and cold allergy 4.Bilateral breast cancer and Inflammatory breast cancer 5.Uncontrolled medical conditions 6.Hepatitis B 7.A history of other malignancies within the last 5 years except for adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix 8.Sever infection 9.Peripheral neuropathy 10.Pleural or pericardial effusion requiring treatment 11.Pregnant or lactating women and women of child bearing potential not using contraception. 12.Grade2-4 Severe peripheral edema. 13.Significant interstitial pneumonia or pulmonary fibrosis by CT scan or X-ray 14.A history of hypersensitivity reaction to drugs formulated with Polysorbate 80 15.Severe psychiatric disorders 16.Patients judged by the investigator to be unfit to be enrolled into the study

Related Information


public contact
Address Nishiyama-kogyo Ochanomizu building 5F, 1-2-13, Yushima, Bunkyo-ku, Tokyo, 113-0034, Japan Japan
Telephone 03-3254-8029
Affiliation Data Center Oncology Unit of Japan Clinical Research Support Unit (J-CRSU) Data Center of Comprehensive Support Project for Oncology Research of Breast Cancer (CSPOR-BC)
scientific contact
Name Hiroji Iwata
Address 1-1 Kanokoden, Chikusa-ku, Nagoya 464-8681, Japan Japan
Telephone 052-762-6111
Affiliation Aichi Cancer Center Hospital Breast Oncology