Randomized parallel group trial of prophylactic compression therapy for chemotherapy-induced peripheral neuropathy (COMPLET Study)

未提供0 个研究点目标入组 120 人开始时间: 2025年3月4日最近更新: 2025年3月31日

试验速览

阶段: 不适用
状态: 招募中
入组人数: 120
主要终点: Incidence of peripheral neuropathy of the lower limbs of CTCAE version 5.0 Grade2 or higher

暂无简介。

•(1) Patients aged between 18 and 75 at the time of consent
•(2) Patients with. Stage1-3C primary breast cancer
•(3) Patients receiving taxane anticancer drugs in perioperative chemotherapy for primary breast cancer
•(4) Eastern Cooperative Oncoligy Group Performance Status 0 or 1
•(5) Patients who can adequately answer patient questionnaires
•(6) Patients who understand this study and given writien consent to participate in this study

•(1) Patients with CTCAE version 5.0 Grade2 or more 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 or painful deep vein thrombosis within one year of screening
•(5) Patients with severe congestive heart failure
•(6)Patients with allergies to the compression gloves or stockings used in this study
•(7) Patients of extremely small or large hands that deviate from the size range of elastic gloves
•(8) Patients of extremely small or large lower limbs that deviate from 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 i nappropriate

Incidence of peripheral neuropathy of the lower limbs of CTCAE version 5.0 Grade2 or higher

时间窗: at the end of four cycles of perioperative chemotherapy with taxane anticancer drugs

Incidence of peripheral neuropathy of the lower limbs classified as CTCAE version 5.0 Grade2 or higher

Incidence of peripheral neuropathy in the hands(at the end of perioperative chemotherapy)
Assessment of CIPN in the hands and lower limbs
Time to onset of CIPN in the hands and lower limbs
Subjective symptoms of CIPN
Grip strength
Evaluation of CIPN onset using vibration sense
Changes in PainVision scores for hands and lower limbs
Evaluation of chemotherapy-induced skin disorders of the hands and lower limbs
Assessment of edema by changes in hands and lower limbs circumference
Completion rate of compression therapy
Relative Dose Intensity of Taxanes
Correlation between compression pressure and incidence of CIPN
Adverse events of compression therapy

发起方

未提供