Preventive effect of compression therapy on CIP

Phase 2

• Conditions: breast cancer

• Registration Number: JPRN-jRCTs032210221
• Lead Sponsor: Hiroko Bando

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-04
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 10

Inclusion Criteria

1 Patients aged between 20 and 70 at the time of consent
2 Patients with stage1-3C primary breast cancer
3 Patients receiving taxane anticancer drugs in perioperative che
motherapy for primary breast cancer
4 Eastern Cooperative Oncology Group Performance status 0 or 1
5 Written informed consent

Exclusion Criteria

1.Patients with peripheral neuropathy in the upper or lower limbs
2.Patients with arterial blood circulation disorders such asa arteriosclerosis obliterans
3.Patients with infectious or inflammatory diseases on the skin aroung the upper and lower limbs
4.Patients diagnosed with acute within 1 year prior screening
5.Patients with severe congestive heart failure
6.Patients with compression stockings or latex allergy used in this study
7.Patients of extremely small or large hands that deviate from the size range of surgical gloves
8.Patients of extremely small or large lower limbs that deviate frome the range of medical compression stocings
9.Patients with thrombophlebitis of the superficial veins of the lower extremeties
10.Other patients that the research doctor deems inappropriate

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of occurrence of CTCAE v4.0 Grade 2 or higher after perioperative chemotherapy with taxane anticancer and completion rate of compression therapy

Secondary Outcome Measures

Name	Time	Method
1. Rates of peripheral neuropathy in the hands and feet after perioperative chemotherapy with taxane<br>2. Evaluation of CIPN in the hands and feet using PNQ<br>3. Period until CIPN expression in the hands and feet by PNQ<br>4. Period until CIPN in the hands and feet of Grade2 or higher<br>5. Incidence and time to onset of skin disorders in hands and feet<br>6. Pressure measurement during compression therapy<br>7. Chemotherapy completion rate and compression reduction rate<br>8. Compression therapy Questionnaire survey