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

NCT05531916 | Active Not Recruiting DMC

• 1 other identifier: B2022-306-01
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

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.

Conditions

Nasopharyngeal Carcinoma; CIPN - Chemotherapy-Induced Peripheral Neuropathy

Keywords

Paclitaxel; Compression therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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.

• 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.

• NRS score

  Pretreatment（baseline), just after 15 minutes of each treatment cycle (each cycle of chemotherapy is 21 days.)

Study Arms (2)

Group A

EXPERIMENTAL

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

Group B

NO INTERVENTION

No intervention was done before and after chemotherapy with paclitaxels.

Interventions

Pressurized gloves and foot caps OTHER

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

Group A

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Evaluator blind design was adopted, and all evaluations were made after the participants had received the intervention and withdrawn the intervention. At this time, the blinded evaluator did not know the tribal groups, while both the participants and researchers knew the trial groups.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The Account and IWRS end of the clinical trial randomization system of Sun Yat-sen University Cancer Center (SYSUCC) randomly determined the limb (left or right) of the participants to receive intervention, and the hand and foot on the same side were classified into the same group during the randomization process.

Study Record Dates

• First Submitted: August 27, 2022
• First Posted: September 8, 2022
• Study Start: November 21, 2022
• Primary Completion: September 27, 2025
• Study Completion (Estimated): June 30, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)