Preventive effect of frozen glove for docetaxel-induced nail toxicities in advanced breast cancer patients

Preventive effect of frozen glove for docetaxel-induced nail toxicities in advanced breast cancer patients - Effect of frozen glove for prevention of docetaxel-induced nail toxicities

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000000478

Enrollment

Registered

2006-09-11

Start date

2006-12-01

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

Simpler freezing method and shorter administration of frozen glove in experimental side (hand)

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Female with pathologically proven breast cancer Clinical stage 4(TNM) or incurable recurrent breast cancer PS(ECOG) 0~2 Docetaxel administration 40mg/m2 planed at least more than once a month (before 1st administration) Preserved major organ function Written informed consent

Exclusion criteria

Exclusion criteria: Infection, Fever = or > 38C Serious comorbidity Interstitial pneumonitis/fibrosis Peripheral neuropathy/edema Raynaud symptom/peripheral arterial disease Finger skin/bone/soft tissue metastasis Positive HBsAg Apparent nail adverse effect Decision by primary physician

Design outcomes

Primary

Measure	Time frame
Occurrence of any nail toxicities at 4 months of Docetaxel infusion	—

Secondary

Measure	Time frame
Occurrence of any grade 2 or higher nail toxicities at 4 months of Docetaxel infusion Time (and total number or amount of Docetaxel administration) until first occurrence of any Docetaxel-induced nail toxicities Detail classification of grade 2 or higher nail toxicities Degree of un-comfort by the use of frozen glove	—

Countries

Japan

Outcome results

None listed

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