Tokyo, Nov. 12 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059735) titled 'Effect of treatment with compression gloves/stockings and ice packs to prevent paclitaxel-induced peripheral neuropathy - Phase 2 study' on Nov. 11.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Osaka City General Hospital
Condition:
Condition - Breast cancer
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - To investigate the preventive effect of compression and cooling of the hands and feet for neuropathy due to paclitaxel
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - wear two surgical gloves and stockings
Eligibility:
Age-lower limit - 20
years-old
<=
Age-upper limit - Not applicable
Gender - Female
Key inclusion criteria - 1) Considered eligible to neoadjuvant or adjuvant weekly paclitaxel therapy (80mg/m2, 12 doses)
2)ECOG performance status 0-1
3)Signed written informed consent
Key exclusion criteria - 1)Poorly controlled complication (infection, diabetes mellitus, and others)
2)Severe pleural effusion and ascites
3)Pregnant or possibly pregnant
4)have with Grade 2 or higher peripheral sensory neuropathy (CTCAE ver4.0)
5)received previous taxane chemotherapy
Target Size - 42
Recruitment Status:
Recruitment status - Enrolling by invitation
Date of protocol fixation - 2022 Year 10 Month 30 Day
Date of IRB - 2022 Year 11 Month 01 Day
Anticipated trial start date - 2022 Year 11 Month 01 Day
Last follow-up date - 2026 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067337
Disclaimer: Curated by HT Syndication.
