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

Nasopharyngeal Carcinoma Clinical Trial

— CIPN  

Official title:

Compression Therapy as a Prophylactic Method Against Paclitaxel-induced Peripheral Neuropathy: a Prospective Self-controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05531916
• Other study ID #: B2022-306-01
• Status: Recruiting
• Phase: N/A
• Start date: November 21, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2023
• Source: Sun Yat-sen University
• Contact: Chunyan Chen
• Phone: 13826423812
• Email: chenchuny[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 182
• Est. completion date: December 31, 2024
• Est. primary completion date: June 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• CIPN - Chemotherapy-Induced Peripheral Neuropathy
• Nasopharyngeal Carcinoma
• Peripheral Nervous System Diseases

Intervention

Other:
• Pressurized gloves and foot caps
Using pressurized gloves and foot caps in order to prevent chemotherapy-induced peripheral neuropathy (CIPN).

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation 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.	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.
Secondary	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.	Pretreatment (baseline), just after 15 minutes of each treatment cycle (each cycle of chemotherapy is 21 days) , 3 and 6 months after chemotherapy completion.
Secondary	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.	Pretreatment (baseline), just after 15 minutes of each treatment cycle (each cycle of chemotherapy is 21 days), 3 and 6 months after chemotherapy completion.
Secondary	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.	Pretreatment(baseline), just after 15 minutes of each treatment cycle (each cycle of chemotherapy is 21 days.)