Glove stocking study for Decetaxel -induced peripheral neuropathy

JRCT ID: jRCTs062200061

Registered date:11/03/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: prostate cancer
• Date of first enrollment: 06/04/2021
• Target sample size: 75
• Study type: Interventional

Intervention(s)

Double the size of surgical gloves one size smaller than the appropriate size (eg, if 6 inches is the appropriate size, wear 5.5 inches) and wear it 30 minutes before docetaxel administration, and 30 minutes after docetaxel administration Have surgical gloves removed.
Wear an appropriate size vein thrombosis prevention stocking (Protect X Intense pressure support (M-L size) for 178cm or less, Protect X Intense pressure support (L-LL size) for 175cm or more) 30 minutes before docetaxel administration. 8 hours after the end of docetaxel administration, remove the stockings.
Other supportive care is optional.
In principle, the administration of the below-mentioned prohibited drugs is prohibited.

Outcome(s)

• Primary Outcome: peripheral neuropathy
• Secondary Outcome: Changes in the claw

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Male

Include criteria

1) Prostate cancer patients to whom docetaxel / prednin therapy is introduced
2) Patients who are over 20 years old and have given their written consent
3) Hand size patients within the size range of commercially available surgical gloves.
4) Protect X Intense pressure support (ML size; height less than 178cm, calf circumference less than 44cm, thigh circumference less than 52cm, foot size 25 to 28cm), Protect X Intense pressure support (L-LL size; height more than 175cm calf Patients who can wear around 42cm to 52cm around the thigh, around 50 to 62cm around the thigh and 27 to 30cm of foot size)

Exclude criteria

1) Patients with peripheral neuropathy at the start of the study
2) Patients who have received medications that may cause peripheral neuropathy in the past.
3) Patients with extremely small or large hands that fall outside the size range of commercially available surgical gloves.
4) Patients with extreme finger and leg deformities
5) Patients with acute deep vein thrombosis
6) Patients with thrombophlebitis of the superficial vein of lower limb
7) Patients with arterial circulation disorders such as obstructive arteriosclerosis, congestive heart failure, inflammatory or purulent diseases of lower limbs, and acute wounds
8) Patients with necrosis / gangrene, severe edema, purulent skin disease after skin transplantation
9) Diabetic patients with peripheral neuropathy
10) Patient whose ankle circumference exceeds 27cm
11) Other patients judged by the investigator to be inappropriate

Related Information

• Primary Sponsor: Kato Takuma