RecruitingNot ApplicableNCT05341141

Effectiveness of Cryotherapy Combined With Compression Therapy for Preventing Chemotherapy-induced Peripheral Neuropathy

Effectiveness of Cryotherapy Combined With Compression Therapy in Preventing Albumin-paclitaxel Induced Peripheral Neuropathy in Breast Cancer Patients


Sponsor

Peking University

Enrollment

102 participants

Start Date

Jun 10, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This is a prospective, multi-center, randomized study designed to evaluate the clinical efficacy of cryotherapy combined with compression therapy in preventing albumin-paclitaxel induced peripheral neuropathy.


Eligibility

Sex: FEMALEMin Age: 20 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether wearing cold gloves and compression socks (cryotherapy + compression) during chemotherapy can prevent nerve damage in the hands and feet — a common and painful side effect called chemotherapy-induced peripheral neuropathy — in breast cancer patients. **You may be eligible if...** - You are a woman between 20 and 70 years old - You have been diagnosed with invasive breast cancer confirmed by biopsy - Your cancer is HER-2 negative - You are scheduled to receive a specific chemotherapy regimen (ddEC-ddT) - You have not had any prior cancer treatment - Your heart function (LVEF) is at least 50% - Your ECOG performance status is 0 or 1 **You may NOT be eligible if...** - You have already started chemotherapy - You are HER-2 positive - Your heart or blood counts do not meet the required thresholds Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEFrozen glove and sock

Preparation of frozen glove and sock: 4℃ for 3 hours.

DRUGddEC-ddT

Epirubicin (E) 90\~100mg/m\^2, i.v., d1 + cyclophosphamide (C) 600 mg/m\^2, i.v., d1, q2w, for 4 cycles followed by albumin-paclitaxel (T) 260 mg/m\^2, i.v., d1, q2w, for 4 cycles.


Locations(1)

Peking University Cancer Hospital

Beijing, Beijing Municipality, China

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NCT05341141


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