Skip to content

Assessment of preventative use of surgical glove for PTX induced peripheral neuropathy

Assessment of preventative use of surgical glove for PTX induced peripheral neuropathy - Assessment of preventative use of surgical glove for PTX induced peripheral neuropathy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000027944
Enrollment
55
Registered
2017-06-26
Start date
2017-07-01
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

For every PTX infusion, each patient wore the 2 smaller SG on one hand (compression therapy side
CT side), and the 2 SG that fit on the other hand (control side) for 90 minutes: the 30 minutes before the administration of PTX, the 30 minutes of PTX infusion itself, and the 30 minutes after the en

Sponsors

Aichi Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1.Who started chemotherapy of wPTX 80mg/m2(plusminus Trastuzumab or Bevacizumab or Pertuzumab plusminus Trastuzumab) 2.ECOG performance status 0 or 1 3.Adequate bone marrow,heart,liver and renal function 4.Informed consent is obtainable from the subject herself in documented form using the Consent Form

Exclusion criteria

Exclusion criteria: 1.Already have peripheral neuropathy >grade 1 by CTCAE v4.0 2.Previous chemotherapy treatment of PTX or nab-PTX 3.The patients whose peripheral intravenous injection is possible only in the area where the gloves are worn 4.History of Raynaud syndrome, hepatitis or other active infectious disease and uncontrolled diabetes 5.Any condition for contraindication of chemotherapy 6.Multiple active cancers (homochromous multiple cancers, or heterochromous multiple cancers with a cancer-free period of less than 5 years prior to randomization) Carcinoma in situ deemed to be cured by local treatment (lesions that are intraepithelial carcinoma or mucosal cancer) is not included as an active multiple cancer 7.Active brain metastasis which require immediate medical procedure or radiation therapy 8.Pleural effusion, ascites or pericardial effusion which require immediate medical procedure

Design outcomes

Primary

MeasureTime frame
The difference in the frequency of occurrence of CIPN (motor/sensory) between the CT side hand and the control side hand was determined by the physician in charge using the Common Terminology Criteria for Adverse Events scale version 4.0 (CTCAE v4.0). Grade 2 or more were considered to be CIPN.

Countries

Japan

Contacts

Public ContactHaruru Kotani

Aichi Cancer Center Department of Breast Oncology

k.haruru@aichi-cc.jp052-762-6111

Outcome results

None listed

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