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Randomized study of frozen gloves/socks for the prevention of paclitaxel-induced neuropathy in breast cancer patients

Randomized study of frozen gloves/socks for the prevention of paclitaxel-induced neuropathy in breast cancer patients - Evaluation of frozen gloves/socks for the prevention of paclitaxel-induced neuropathy

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000034966
Enrollment
44
Registered
2018-11-21
Start date
2017-02-01
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

breast cancer

Interventions

Frozen gloves/socks are frigerated at -20C. With every paclitaxel infusion, each patient wear an frozen gloves/socks for a total of 90 minutes on the both hands and feet (15 minutes before the adminia

Sponsors

National hospital organization KURE medical center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: pathologically proven invasive breast cancer planned to receive 4 cycle of weekly paclitaxel treatment adequate hematologic, hepatic, and renal function Eastern Cooperative Oncology Group performance status of 0 to 1 providing written informed consent

Exclusion criteria

Exclusion criteria: peripheral neuropathy grade 2 or higher receiving any agents that altering peripheral neuropathy Raynaud's phenomenon pregnancy or breast feeding any other reason of no-suitable for registration

Design outcomes

Primary

MeasureTime frame
FACT-NTX(Functional Assessment of Cancer Therapy-neurotoxicity) score

Secondary

MeasureTime frame
FACT-Taxane score, PNQ(Patient Neurotoxicity Questionnaire), CTCAE (common terminology criteria for adverse event) for periphereal neuropathy, safety, Evaluation of the temperature of the tip of each hand and foot

Countries

Japan

Contacts

Public ContactHideo Shigematsu

National hospital organization KURE medical center Breast surgery

shigematu1330@yahoo.co.jp0823-22-3111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026