An interventional study of Compression therapy using surgical gloves in Chemotherapy-induced Peripheral Neuropathy, sponsored by Young-Joon Kang. Active, not recruiting at 1 site in South Korea. Open to female participants aged 19 Years to 69 Years. Per ClinicalTrials.gov, last updated 2026-02-27.
Sponsored by Young-Joon Kang · Not applicable, Interventional, and Prevention
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.
Chemotherapy-induced peripheral neuropathy (CIPN) is associated with side effects of taxanes, including paclitaxel. The common side effect may adversely affect the quality of life. However, no treatment for CIPN can be strongly recommended. Therefore, prevention is important. Cryotherapy, compression therapy, and exercise therapy can be considered for prevention, but no definitive recommendations are available. Studies with wider sample sizes are needed to confirm the efficacy and the preventive methods are complex for application. The study use surgical gloves for compression therapy to reduce discomfort and increase compliance with the procedure.
Patients with stage II-III breast cancer who receive paclitaxel chemotherapy for at least 12 weeks in six academic hospitals in South Korea will participate in the study. The study design is a multicenter, open-label, randomized controlled trial. The patients are randomly assigned to intervention or control groups. Intervention patients will wear two-layer of normal-sized surgical gloves on both hands during chemotherapy infusion. The primary outcome is to demonstrate the preventive effect of compression therapy using surgical gloves as measured by the change in the neurotoxicity of FACT-Tax questionnaire.
Young-Joon Kang is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Study participants wear two-layer of normal-sized surgical gloves on both hands during chemotherapy infusion
Device: Compression therapy using surgical gloves
No intervention is provided on both hands.
Intervention group wear two-layer of normal-sized surgical gloves on both hands during chemotherapy infusion
Changes in the 11 items neurotoxicity component of the Functional Assessment of Cancer Therapy-Taxane (FACT-NTX) Therapy subscale
The change in FACT-NTX will be divided into a good outcome (change in FACT-NTX less than five from baseline to target timeframe) versus a poor outcome (change in FACT NTX greater than or equal to five from baseline to target timeframe). The difference in the number of poor outcome participants will compare between the two groups. The FACT-NTX is 5-point Likert-type scale. Each item measures on a 0-4 scale (0, not at all; 4, very much). A greater change in the FACT-NTX score was considered a clinically meaningful increase in CIPN.
Time frame: Before starting paclitaxel course (baseline), and 1~2 weeks from finishing paclitaxel course chemotherapy (target)
Changes in 16 items component of the Functional Assessment of Cancer Therapy-Taxane (FACT-Taxane) Therapy subscale
The score changes in 16 items (neurotoxicity and taxane) component of the FACT-Taxane scale will be compared between the two groups. The FACT-Taxane is 5-point Likert-type scale. Each item measures on a 0-4 scale (0, not at all; 4, very much). A scale of 0 indicates a better outcome, and 4 indicates a worse outcome.
Time frame: Baseline, during paclitaxel course (about 1.5 months after starting), 1~2 weeks from finishing course, and six months after finishing paclitaxel course
Changes in 27 items component of the Functional Assessment of Cancer Therapy-General (FACT-G) scale
The score changes in general 27 items component of the FACT-G scale will be compared between the two groups. The FACT-G consists of four well-being subscales; physical well-being (7-item), social/family well-being (7-item), emotional well-being (6-item), and functional well-being (7-item). The FACT-G is 5-point Likert-type scale (0, not at all; 4, very much). For physical and emotional well-being, the higher the sum of scores, the lower the quality of life; for social/family and functional well-being, the higher the sum of scores, the higher the quality of life.
Time frame: Baseline, during paclitaxel course (about 1.5 months after starting), 1~2 weeks from finishing course, and six months after finishing paclitaxel course
Changes in the 11 items neurotoxicity component of the Functional Assessment of Cancer Therapy-Taxane (FACT-NTX) Therapy subscale at additional periods.
The change in FACT-NTX will be divided into a good outcome (change in FACT-NTX less than five from baseline to target timeframe) versus a poor outcome (change in FACT NTX greater than or equal to five from baseline to target timeframe). The difference in the number of poor outcome participants will compare between the two groups. The FACT-NTX is 5-point Likert-type scale. Each item measures on a 0-4 scale (0, not at all; 4, very much). A greater change in the FACT-NTX score was considered a clinically meaningful increase in CIPN.
Time frame: During paclitaxel course (about 1.5 months after starting) and six months after finishing paclitaxel course
FACT-NTX 11-item total score (continuous)
Mean FACT-NTX 11-item total score at each time point and change from baseline, analyzed using mixed-effects model for repeated measures (MMRM). Higher scores indicate greater neurotoxicity (range 0-44).
Time frame: Baseline, during chemotherapy (mid-cycle), 1-2 weeks after completion of paclitaxel, and 6 months after completion
Change in National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) for CIPN
NCI-CTCAE for CIPN is a method for reporting adverse event severity by a combination of clinical evaluation. The adverse effects of CIPN to be investigated are peripheral motor, sensory neuropathy, dysesthesia, paresthesia, neuralgia, and skin/nail toxicity.
Time frame: Baseline, during paclitaxel course (about 1.5 months after starting), 1~2 weeks from finishing course, and six months after finishing paclitaxel course
Comfort with intervention scale score
Comfort with the intervention (two-layer of surgical gloves) will be assessed on 4-point scale. The points are classified 0=dissatisfied; 1=not satisfied; 2=satisfied; 3=very satisfied.
Time frame: during paclitaxel course (about 1.5 months after starting), 1~2 weeks from finishing course, and six months after finishing paclitaxel course
Hand-specific sub-score
FACT-NTX hand-specific sub-score (4 items: numbness/tingling in hands, discomfort in hands, trouble buttoning buttons, difficulty feeling shape of small objects; 0-16). The intervention directly targets the upper extremities; this sub-score is expected to capture the primary treatment effect.
Time frame: Baseline, during chemotherapy, 1-2 weeks after completion, 6 months after completion
Foot-specific sub-score
FACT-NTX foot-specific sub-score (numbness/tingling in feet, discomfort in feet, trouble walking; 0-12). Internal control to assess body-region specificity of intervention effect
Time frame: Baseline, during chemotherapy, 1-2 weeks after completion, 6 months after completion
Subgroup analysis
Subgroup analysis by paclitaxel schedule (weekly 80 mg/m² × 12 vs 3-weekly 175 mg/m² × 4): primary and secondary outcomes
Time frame: 1-2 weeks after completion of paclitaxel
This study is active, not recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Young-Joon Kang