A randomized Phase 2 study of the efficacy of cold therapy by using frozen gloves or compression therapy using surgical gloves on nab-paclitaxel induced peripheral neuropathy in breast cancer patients.

A randomized Phase 2 study of the efficacy of cold therapy by using frozen gloves or compression therapy using surgical gloves on nab-paclitaxel induced peripheral neuropathy in breast cancer patients. - Prophylactic efficacy of frozen gloves or surgical gloves on nab-paclitaxel induced peripheral neuropathy.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000030536

Enrollment

Registered

2017-12-24

Start date

2017-08-29

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

During chemotherapy, wear a frozen glove on one hand and a surgical glove on the other hand continuously, as for frozen glove from 15 minutes before the start of administration of nab-PTX until 15 min

dominant hand&quot

is assigned randomly as the allocation factor. Using the thermography, the fingertip temperature of both hands before and after wearing the glove was measured.

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Women with pathologically proven primary or recurrent breast cancer, 20 years of age and older No peripheral sensory/motor neuropathy or Grade 1 peripheral sensory/motor neuropathy without left/right differences Patients who can answer Japanese questionnaire without assistance With written informed consent

Exclusion criteria

Exclusion criteria: With allergy for material of frozen globe and surgical glove Patients with neuropathic pain due to diseases such as diabetes and herpes zoster

Design outcomes

Primary

Measure	Time frame
The incidence of grade 2 or higher nab-paclitaxel-induced peripheral neuropathy. Comparison of prophylactic efficacy of cold therapy using frozen gloves and compression therapy using surgical gloves on nab-paclitaxel-induced peripheral neuropathy.	—

Secondary

Measure	Time frame
1.Comparison of prophylactic efficacy of cold therapy using frozen gloves and compression therapy using surgical gloves on nab-paclitaxel-induced peripheral neuropathy with historical control. 2.Withdrawal of intervention procedures 3.Adverse events of interventional procedures 4.Factors affecting nab-paclitaxel-induced peripheral neuropathy (clinical background, administration of analgesic adjuvant, involvement of dominant hand, etc.) 5.The evaluation of nab-paclitaxel-induced peripheral neuropathy by using the Patient Neurotoxicity Questionnaire and Functional Assessment of Cancer Therapy.	—

Measure

Time frame

1.Comparison of prophylactic efficacy of cold therapy using frozen gloves and compression therapy using surgical gloves on nab-paclitaxel-induced peripheral neuropathy with historical control. 2.Withdrawal of intervention procedures 3.Adverse events of interventional procedures 4.Factors affecting nab-paclitaxel-induced peripheral neuropathy (clinical background, administration of analgesic adjuvant, involvement of dominant hand, etc.) 5.The evaluation of nab-paclitaxel-induced peripheral neuropathy by using the Patient Neurotoxicity Questionnaire and Functional Assessment of Cancer Therapy.

—

Countries

Japan

Contacts

Public ContactYuko Kanbayashi

Kyoto Prefectural University of Medicine Outpatient Oncology Unit

ykokanba@koto.kpu-m.ac.jp075-251-5111

Outcome results

None listed

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