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

April 24, 2026 updated by: Chen Chunyan, Sun Yat-sen University

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

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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

182

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Sun Yat-sen University Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
Participants wear pressurized gloves and foot caps for 15 minutes before their chemotherapy treatment, during the treatment, and for 15 minutes after it ended.
Other: Pressurized gloves and foot caps
Using pressurized gloves and foot caps in order to prevent chemotherapy-induced peripheral neuropathy (CIPN).
No Intervention: Group B
No intervention was done before and after chemotherapy with paclitaxels.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation change in CTCAE 5.0 grade for CIPN (The most severe grade is the final grade)
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
EORTC QLQ-CIPN20 score
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.
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.
EORTC QLQ-C30 score
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.
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.
NRS score
Time Frame: 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.
Pretreatment（baseline), just after 15 minutes of each treatment cycle (each cycle of chemotherapy is 21 days.)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 21, 2022

Primary Completion (Actual)

September 27, 2025

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

August 27, 2022

First Submitted That Met QC Criteria

September 7, 2022

First Posted (Actual)

September 8, 2022

Study Record Updates

Last Update Posted (Actual)

April 30, 2026

Last Update Submitted That Met QC Criteria

April 24, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2022-306-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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