This is a single-center, self-controlled, evaluator-blinded prospective study, which applies pressurized gloves and foot caps to prevent paclitaxel-induced peripheral neuropathy in patients with nasopharyngeal carcinoma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
182
Using pressurized gloves and foot caps in order to prevent chemotherapy-induced peripheral neuropathy (CIPN).
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGEvaluation change in CTCAE 5.0 grade for CIPN (The most severe grade is the final grade)
The incidence of common adverse event evaluation criteria (CTCAE) 5.0 ≥ 2°CIPN after compression therapy with pressurized gloves and foot caps is used to objectively assess the peripheral neurotoxicity of chemotherapy. The grade of CTCAE 5.0 CIPN before treatment was the baseline (=0). We assess changes from baseline at 15 minutes after the end of each cycle, 3 and 6 months after the end of treatment. (The duration of chemotherapy varies according to the type of paclitaxel and the interval of each cycle of chemotherapy is 21 days). CIPN includes the symptoms of a sensory nerve and motor nerve injury. The symptoms are graded from 1 to 5, indicating none, mild, severe, life-threatening, and death. The higher the grade, the worse the neurotoxicity. The most severe grade is the final grade for each patient.
Time frame: Pretreatment (baseline=0), just after 15 minutes of each treatment cycle (each cycle of chemotherapy is 21 days) , 3 and 6 months after chemotherapy completion.
EORTC QLQ-CIPN20 score
The European Organization for Research and Treatment of Cancer Evaluation Scale of Chemotherapy-Induced Peripheral Neuropathy (EORTC QLQ-CIPN20) is a validated tool to objectively assess the peripheral neurotoxicity of chemotherapy. The evaluation was performed before treatment, 15 minutes after each cycle of chemotherapy, and 3 and 6 months after the end of treatment. This scale includes the symptoms of sensory nerve, motor nerve, and autonomic nerve injury and its impact on life. A total of 20 items are included. Each item is graded from 1 to 4, indicating none, occasionally, often, and very often. According to the patient's self-reported score, the higher the score, the worse the quality of life.
Time frame: Pretreatment (baseline), just after 15 minutes of each treatment cycle (each cycle of chemotherapy is 21 days) , 3 and 6 months after chemotherapy completion.
EORTC QLQ-C30 score
The European Organization for Cancer Research and Treatment QLQ-C30 （EORTC QLQ-C30）: a quality of life instrument for use in international clinical trials in oncology. The evaluation was performed before treatment, 15 minutes after each cycle of chemotherapy, and 3 and 6 months after the end of treatment. A total of 30 items are included. Each item is graded from 1 to 4, except for items 29 and 30, indicating not at all, a little, quite a bit, and very much, with higher scores indicating poorer quality of life.
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Time frame: Pretreatment (baseline), just after 15 minutes of each treatment cycle (each cycle of chemotherapy is 21 days), 3 and 6 months after chemotherapy completion.
NRS score
The Numerical Rating Scale (NRS) scale is a validated tool to objectively assess the tolerance of participants for gloves and coats, with a minimum score of 0 and a maximum of 10. A score of 0 indicates complete tolerance, a score of 1-3 indicates mild intolerance, a score of 4-6 indicates moderate intolerance, and a score of 7-10 indicates severe intolerance.
Time frame: Pretreatment（baseline), just after 15 minutes of each treatment cycle (each cycle of chemotherapy is 21 days.)