Multicenter randomized trial to evaluate the efficacy of compression therapy with Elastic Compression Gloves and Stockings for prevention of chemotherapy-induced neuropathy in breast cancer patients

Multicenter randomized trial to evaluate the efficacy of compression therapy with Elastic Compression Gloves and Stockings for prevention of chemotherapy-induced neuropathy in breast cancer patients - RCT of compression therapy with ECGS for prevention of CIPN

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000036329

Enrollment

100

Registered

2019-06-01

Start date

2019-06-15

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

Compression therapy with Elastic Compression Gloves and Stockings(ECGS) to the hand and the foot of intervention side:wearing ECGS to the intervention side in all 12 cycles from 30 minutes before admi

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Breast cancer patients planning to receive more than 12cycles of weekly Paclitaxel therapy

Exclusion criteria

Exclusion criteria: Patients who have CTCAE more than grade1 neuropathy and/or skin disorders

Design outcomes

Primary

Measure	Time frame
1)Score of hands in Patient Neurotoxicity Questionnaire (PNQ) until 12cycle Day8 2)CTCAE grade of hands in until 12cycle Day8 3)Score of feet in Patient Neurotoxicity Questionnaire (PNQ) until 12cycle Day8 4)CTCAE grade of feet in until 12cycle Day8	—

Secondary

Measure	Time frame
1)Time to PNQ score D 2)Time to CTCAE grade 2 3)Grooved pegboard test 4) Semmes-Weinstein monofilament Test 5)Skin and subcutaneous tissue disorders (CTCAE grade2) 6)Temperature of hands and feet before and after compression 7)Ratio of cases dropping out 8)CIPN 6,12,18,24months after cycle12 9)Pressure of ECGS	—

Countries

Japan

Contacts

Public ContactKazuo Sakamoto

General Incorporated Association Kyoto Breast Cancer Research Network KBCRN Study Office

info@kyoto-breast-cancer.org075-585-7861

Outcome results

None listed

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