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

Sun Yat-sen University

Status: Enrolling

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

Treatments: Other: Pressurized gloves and foot caps

Study type: Interventional

Funder types: Other

Identifiers

NCT05531916

B2022-306-01

Details and patient eligibility

About

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.

Enrollment: 182 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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182 participants in 2 patient groups

Group A

Experimental group

Description:

Participants wear pressurized gloves and foot caps for 15 minutes before their chemotherapy treatment, during the treatment, and for 15 minutes after it ended.

Treatment:

Other: Pressurized gloves and foot caps

Group B

No Intervention group

Description:

No intervention was done before and after chemotherapy with paclitaxels.