Evaluation of the effect of compression therapy by using surgical gloves on nab-paclitaxel-induced peripheral neuropathy in primary breast cancer patients:a phase 3 multicenter study (single-armed study)

Evaluation of the effect of compression therapy by using surgical gloves on nab-paclitaxel-induced peripheral neuropathy in primary breast cancer patients:a phase 3 multicenter study (single-armed study) - Evaluation of the effect of compression therapy by using surgical gloves on nab-paclitaxel-induced peripheral neuropathy:a phase 3 multicenter study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000024836

Enrollment

Registered

2016-11-14

Start date

2016-10-15

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

wear two surgical gloves of the same size on both hands

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1)Histologically orcytologically confirmed invasive breast cancer 2) Considered eligible to neoadjuvant chemotherapy or adjuvant chemotherapy 3)ECOG performance status 0-1 4)No peripheral sensory / motor neuropathy (CTCAE ver4.0) 5)Adequate organ function, Adequate organ function 6)Signed written informed consent

Exclusion criteria

Exclusion criteria: 1)have any peripheral sensory / motor neuropathy (CTCAE ver4.0) 2)received previous chemotherapy 3) Multiple primary cancer. However, carcinoma in situ can be cured by local treatment is not included in multiple primary cancer 4) Synchronous bilateral breast cancer 5) Brain metastasis 6) Poorly controlled complication (infection, diabetes mellitus, and others)

Design outcomes

Primary

Measure	Time frame
Occurrence of nab-paclitaxel-induced peripheral neuropathy of grade 2 or higher	—

Secondary

Measure	Time frame
1) The evaluation of nab-paclitaxel-induced PN by using the Patient Neurotoxicity Questionnaire (we call PNQ) 2) The changes in the temperature of each fingertip 3) Withdrawal rate of wearing sutgical gloves 4) Adverse events of wearung surgical gloves	—

Countries

Japan

Contacts

Public ContactShigeru Tsuyuki

Osaka Red Cross Hospital Department of Breast Surgery

tyksgr@osaka-med.jrc.or.jp06-6774-5111

Outcome results

None listed

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