role of frozen sock

Evaluation the use of frozen sock to prevent docetaxel-induced peripheral neuropathy in breast cancer patients

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0002662

Enrollment

Registered

2018-01-19

Start date

2017-08-30

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : Patients receiving docetaxel at a dose of 75 to 100 mg/m(2) every 3 weeks were eligible for this study. a total of 30 patients are planned for enrollment. The anticipated duration of

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: -histopathologically proven breast cancer patients aged from 20 to 75 -AJCC stage T0-T4, N1-N2, M0 -ECOG Performance status 0 or 1 -are planning for adjuvant chemotherapy -are planning for neoadjuvant chemotherapy -are planning for docetaxel administration at doses between 75 mg/m2 and 100 mg/m2 as a 90 minutesintravenous infusion every 3 weeks, either alone or in combination with other cytotoxic agents

Exclusion criteria

Exclusion criteria: -Raynaud syndrome -history of peripheral neuropathy (grade 2) -history of chemotherapy with taxane agents (docetaxel, paclitaxel, nab-paclitaxel) -skin or ungual disorder -distant metastasis -cold intolerance -arteriopathy -history of hypersensitivity to docetaxel -enrolled in the other clinical study

Design outcomes

Primary

Measure	Time frame
Peripheral neuropathy- motor nerve (peroneal, tibial) and sensory nerve (superficial peroneal, medial plantar, sural) conduction study	—

Secondary

Measure	Time frame
skin and nail disorder	—

Countries

Korea, Republic of

Contacts

Public ContactEun Young Kim

Kangbuk Samsung Medical Center

gimo25@hanmail.net+82-2-2001-1730

Outcome results