A phase II study of the efficacy of Compression therapy by using surgical gloves for prevention of nab-paclitaxel-induced peripheral neuropathy in primary and metastatic breast cancer patients.

A phase II study of the efficacy of Compression therapy by using surgical gloves for prevention of nab-paclitaxel-induced peripheral neuropathy in primary and metastatic breast cancer patients. - A phase II study of the efficacy of Compression therapy by using surgical gloves for prevention of nab-paclitaxel-induced peripheral neuropathy in breast cancer patients.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000014064

Enrollment

Registered

2014-05-27

Start date

2013-07-16

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 a Surgical glove on the dominant hand wear nothing on the non-dominant hand

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1)Histologically or cytologically confirmed invasive breast cancer. 2)Considered eligible to neoadjuvant chemotherapy, adjuvant chemotherapy, or chemotherapy as recurrence treatment. 3)Age>=20years old=<75 years 4)ECOG performance status 0-1 5)No Peripheral sensory/motor neuropathy (CTCAE ver4.0) 6) Adequate organ function, Adequate organ function within 2 weeks Leukocyte count >= 4000/mm3 Neutrophil count >= 1500/mm3 Platelet count >= 100000/mm3 Hemoglobin >= 9.0 g/dl Aspartate aminotransferase level =<ULN x 2.5 Alanine aminotransferase level =<ULN x 2.5 Total bilirubin =< 1.5 mg/dl Serum creatinine =< 1.2 mg/dl 7) No clinical abnormality by electrocardiography 8) No interstitial pneumonia and pulmonary fibrosis diagnosed by chest X-rays or CT scan 9) Signed written informed consent

Exclusion criteria

Exclusion criteria: 1) Multiple primary cancer. However, carcinoma in situ can be cured by local treatment is not included in multiple primary cancer. 2) Synchronous bilateral breast cancer. 3) Poorly controlled complication (infection, diabetes mellitus, and others). 4) Hypersensitivity to any agents necessary in the planned treatment. 5) Positive for HBs antigen. 6) Previous history of serious heart or lung disease 7) Peripheral sensory/motor neuropathy 8) Transfusion within 2 years 9) Previous history or receiving treatment of dementia or serious psychiatric disorder. 10) Large pleural effusion or ascites 11) Women who are pregnant, lactating or with childbearing potential. 12) Ineligible based on decision of an investigator.

Design outcomes

Primary

Measure	Time frame
Grade 2=< Sensory/motor peripheral neuropathy	—

Countries

Japan

Contacts

Public ContactShigeru Tsuyuki

Osaka Red Cross Hospital Breast Surgery

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

Outcome results

None listed

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