A randomized controlled trial compression therapy for CIPN

JRCT ID: jRCTs032240534

Registered date:09/12/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Primary breast cancer
• Date of first enrollment: 09/12/2024
• Target sample size: 120
• Study type: Interventional

Intervention(s)

Participants in the intervention group:
Compression therapy of hands and lower limbs is performed from 15 minutes before administration of taxane to 15 minutes after the end of administration
Compression therapy of hands: Wearing elastic gloves on both hands
Compression therapy of lower limbs: Wearing two layers of elastic stockings on each lower limbs

Control group: Aggressive supportive care

Outcome(s)

• Primary Outcome: Incidence of peripheral neuropathy of the lower limbs of CTCAE version 5.0 Grade2 or higher at the end of four cycles of perioperative chemotherapy with taxane anticancer drugs

Secondary Outcome

1. Incidence of peripheral neuropathy in the hands (CTCAEv5.0 grade 2 or higher) at the end of perioperative chemotherapy using taxane anticancer drugs
2.Assessment of CIPN in the hands and lower limbs using the Patient Neurotoxicity Questionnaire (PNQ)
3.Time to onset of CIPN in the hands and lower limbs (CTCAe v5.0 Grade 2 or higher)
4.Subjective symptoms of CIPN based on patient diary PRO-CTCAE TM Japanese version
5.Grip strength
6.Evaluation of CIPN onset using vibration sense (bilateral medial malleolus, Rydel-Seiffer tuning fork)
7.Changes in PainVision scores for hands and lower limbs
8.Evaluation of chemotherapy-induced skin disorders of the hands and lower limbs using CTCAEv5.0
9.Assessment of edema by changes in hands and lower limbs circumference
10.Completion rate of compression therapy
11.Relative Dose Intensity of Taxanes
12.Correlation between compression pressure and incidence of CIPN
13.Adverse events of compression therapy

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 75age old
• Gender: Female

Include criteria

(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

Exclude criteria

(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

Related Information

• Primary Sponsor: Bando Hiroko
• Source(s) of Monetary Support: University of Tsukuba Hospital,Japan Society for the Promotion of Science