Fudan University Shanghai Cancer Center
Shanghai, China
Location status: Recruiting
NCT Number: NCT07638774
This study is a prospective, multicenter, phase Ⅲ trial to evaluate of the compression/ice gloves/socks efficacy in UTD1-induced peripheral sensory and motor neuropathy. 324 patients will be included. All patients will be randomly divided into three groups at a ratio of 1:1:1. Group A is the blank control group, group B is the compression glove/sock group, and group C is the ice glove/sock group.
Interested in participating?
Request Info18 year–75 year
Female
Interventional
Not applicable
Shanghai, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Absolute Neutrophil Count (ANC) ≥1,500/mm 3 (1.5 ×10 9/L), white blood cell count (WBC) ≥3.5×10 9/L, platelets ≥75,000/mm 3 (75×10 9/L), hemoglobin ≥9 g/dL (90 g/L), no blood transfusion and blood products within 14 days, no G-CSF and other hematopoietic stimulation factor within 7 days.
Serum creatinine ≤1.5 × Upper Limit of Normal (ULN); AST, ALT, ALP exceeding the upper limit of normal but ≤ 2.5 × ULN when no liver metastasis; AST, ALT, ALP exceeding the upper limit of normal but ≤ 5 × ULN when liver metastasis.
Exclusion criteria
Patients in group B wear pressure gloves/socks of a smaller size for both feet and one hand 15 minutes before medication and 15 minutes after infusion, for a total of 120 minutes.
Patients in group C wear ice gloves/socks on both feet and one hand 15 minutes before medication and 15 minutes after infusion, for a total of 120 minutes.
Time frame: 6 weeks
Time frame: 6 weeks
Time frame: 6 weeks
Time frame: 6 weeks
Time frame: 6 weeks
Time frame: 6 weeks
Number of participants experiencing adverse events related to the use of cryotherapy gloves/socks or compression gloves/socks, including skin injury, pain, discomfort, cold intolerance, numbness, and other device-related adverse events, assessed according to CTCAE v5.0.
Contact information is provided by the study sponsor or research team.
Jian Zhang, MD,Phd
CONTACT
Xichun Hu, MD,Phd
CONTACT
Fudan University
Other
Reducing Peripheral Sensory and Motor Neuropathy Induced by UTD1 With Compression/Ice Gloves/Socks, a Multi-center Prospective Phase III Trial (YBCSG-20-02).
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06439771
Breast Diseases, Breast Neoplasms
Shanghai, Shanghai Municipality, China
View Trial DetailsNCT07354022
Breast Diseases, Breast Neoplasms
Beijing, Beijing Municipality, China
View Trial DetailsNCT07461454
Breast Diseases, Breast Neoplasms
Shanghai, Shanghai Municipality, China
View Trial DetailsNCT05860465
Breast Diseases, Breast Neoplasms
Guangzhou, Guangdong, China
View Trial Details