A Randomized Controlled Trial Using Surgical Gloves to Prevent Chemotherapy-induced Peripheral Neuropathy by Paclitaxel in Breast Cancer Patients

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This study aims to demonstrate the preventive effect of compression therapy using surgical gloves in chemotherapy-induced peripheral neuropathy. Patient-reported outcome measures (PROMs) are utilized for comparing the change in neuropathic pain between intervention and control groups. Among the PROMs, the neurotoxicity component of the functional Assessment of Cancer Therapy-taxane (FACT-Tax) is used for good and poor outcomes between baseline and post-chemotherapy in paclitaxel-treated breast cancer patients.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 19
Maximum Age: 69
Healthy Volunteers: f
View:

• Age greater or equal to 19 years, under 70 years old

• Stage II-III breast cancer

• No distant metastasis

• Patient scheduled to be receiving adjuvant or neoadjuvant paclitaxel for at least 12 weeks

• Signed informed consent

• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥60%)

Locations
Other Locations
Republic of Korea
Incheon St. Mary's Hospital
RECRUITING
Incheon
Contact Information
Primary
Young-Joon Kang
yjkang.md@gmail.com
+82 32-280-5179
Time Frame
Start Date: 2023-06-13
Estimated Completion Date: 2026-11-30
Participants
Target number of participants: 104
Treatments
Experimental: Compression therapy using surgical gloves
Study participants wear two-layer of normal-sized surgical gloves on both hands during chemotherapy infusion
No_intervention: Control
No intervention is provided on both hands.
Sponsors
Leads: Young-Joon Kang

This content was sourced from clinicaltrials.gov