Assessment of preventative use of surgical glove for PTX induced peripheral neuropathy

Not Applicable

• Conditions: breast cancer

• Registration Number: JPRN-UMIN000027944
• Lead Sponsor: Aichi Cancer Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-06-26
• Study Completion: 2019-12-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up continuing
• Sex: Female
• Target Recruitment: 55

Inclusion Criteria

Not provided

Exclusion Criteria

1.Already have peripheral neuropathy >grade 1 by CTCAE v4.0 2.Previous chemotherapy treatment of PTX or nab-PTX 3.The patients whose peripheral intravenous injection is possible only in the area where the gloves are worn 4.History of Raynaud syndrome, hepatitis or other active infectious disease and uncontrolled diabetes 5.Any condition for contraindication of chemotherapy 6.Multiple active cancers (homochromous multiple cancers, or heterochromous multiple cancers with a cancer-free period of less than 5 years prior to randomization) Carcinoma in situ deemed to be cured by local treatment (lesions that are intraepithelial carcinoma or mucosal cancer) is not included as an active multiple cancer 7.Active brain metastasis which require immediate medical procedure or radiation therapy 8.Pleural effusion, ascites or pericardial effusion which require immediate medical procedure

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The difference in the frequency of occurrence of CIPN (motor/sensory) between the CT side hand and the control side hand was determined by the physician in charge using the Common Terminology Criteria for Adverse Events scale version 4.0 (CTCAE v4.0). Grade 2 or more were considered to be CIPN.