Preventive effect of compression therapy on CIPN

JRCT ID: jRCTs032210221

Registered date:04/08/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: breast cancer
• Date of first enrollment: 07/10/2021
• Target sample size: 10
• Study type: Interventional

Intervention(s)

Compression therapy of the upper and lower limbs is performed from 15 minutes before administration of the taxane (paclitaxel or docetaxel) to 15 minutes after the end of administration.
1. Compession therapy of hand: Wear two surgical gloves on both hands.
2. Compression therapy of feet: Wear two medical elastic stockings on both legs.

Outcome(s)

• Primary Outcome: 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

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 70age old
• Gender: Female

Include 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

Exclude 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

Related Information

• Primary Sponsor: Hiroko Bando