Compression Therapy as a Prophylactic Method Against CIPN: a Prospective Self-controlled Trial

Not Applicable

Recruiting

• Conditions: CIPN - Chemotherapy-Induced Peripheral Neuropathy; Nasopharyngeal Carcinoma

• Registration Number: NCT05531916
• Lead Sponsor: Sun Yat-sen University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-27
• Study First Submitted QC: 2022-09-07
• Study First Posted: 2022-09-08
• Study Start: 2022-11-21
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-13
• Last Update Posted: 2023-04-14
• Primary Completion: 2024-06-20
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 182

Inclusion Criteria

• Age range from 18 to 70
• ECOG physical status score: 0-2
• Newly diagnosed patients who have not received antitumor therapy
• Nasopharyngeal carcinoma confirmed by pathology
• Paclitaxel is included in the chemotherapy regimen
• Laboratory examination results within one week before enrollment should meet the following conditions: neutrophils (ANC) ≥1.5×109/L, platelets (PLT) ≥80×109/L, total bilirubin (TBI) ≤1.5× upper limit of normal value (2mg/ dL), ALT and AST ≤2× upper limit of normal value
• Patients voluntarily participate and provide written informed consent

Exclusion Criteria

• Patients with peripheral neuropathy, hand-foot syndrome, and dermatomyositis
• Patients with missing fingers or toes
• Patients with Raynaud's syndrome and peripheral vascular ischemia
• Pregnant or lactating women
• Those considered unsuitable for inclusion by the researcher

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Evaluation change in CTCAE 5.0 grade for CIPN (The most severe grade is the final grade)	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.	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.

Secondary Outcome Measures

Name	Time	Method
EORTC QLQ-CIPN20 score	Pretreatment (baseline), just after 15 minutes of each treatment cycle (each cycle of chemotherapy is 21 days) , 3 and 6 months after chemotherapy completion.	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.
EORTC QLQ-C30 score	Pretreatment (baseline), just after 15 minutes of each treatment cycle (each cycle of chemotherapy is 21 days), 3 and 6 months after chemotherapy completion.	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.
NRS score	Pretreatment（baseline), just after 15 minutes of each treatment cycle (each cycle of chemotherapy is 21 days.)	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.

Trial Locations

Locations (1)

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China