Actively Recruiting

Phase Not Applicable
Age: 20Years - 70Years
FEMALE
NCT05341141

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

Led by Peking University · Updated on 2022-06-13

102

Participants Needed

1

Research Sites

229 weeks

Total Duration

On this page

Sponsors

P

Peking University

Lead Sponsor

C

CSPC Ouyi Pharmaceutical Co., Ltd.

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 20Years - 70Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female patients aged from 20 to 70 years old
  • Histologically confirmed invasive breast cancer
  • HER-2 negative status defined by IHC 0 or 1+, or FISH negative
  • Tumor larger than 2 cm with either ER less than 1% and PR less than 1%, or tumor larger than 2 cm with ER at least 1% and confirmed regional lymph node metastasis
  • No prior treatment for breast cancer
  • Planned neoadjuvant chemotherapy with dose-dense epirubicin and cyclophosphamide followed by dose-dense albumin-paclitaxel
  • At least one measurable disease according to RECIST 1.1
  • Eastern Cooperative Oncology Group performance status of 0 or 1
  • Left ventricular ejection fraction of at least 50%
  • ECG results normal or with no clinically significant abnormalities
  • Bone marrow function with absolute neutrophil count at least 1.5x10^9/L, platelets at least 100x10^9/L, and hemoglobin at least 90 g/L
  • Liver and kidney function with ALT and AST both at or below 2.5 times the upper limit of normal, total bilirubin and serum creatinine at or below 1.5 times the upper limit of normal
  • Good compliance with treatment and follow-up, understanding of study procedures, and signed informed consent
Not Eligible

You will not qualify if you...

  • Breast cancer with distant metastasis
  • History of other malignancies
  • Past or present sensory or motor neurological diseases
  • Known allergy to any components of the study treatment
  • Presence of cerebral thrombosis
  • Past or present severe cardiac disease or discomfort, including uncontrolled arrhythmia, atrial tachycardia, significant ventricular arrhythmia, high-grade atrioventricular block, angina requiring medication, significant valvular heart disease, ECG showing transmural myocardial infarction, uncontrolled hypertension, myocardial infarction, or congestive heart failure
  • Serious illnesses such as severe neurological or psychiatric disorders preventing informed consent, active uncontrolled infection, active peptic ulcer, or unstable diabetes
  • Pregnancy, breastfeeding, or refusal to use adequate contraception before and during the study
  • Investigator judgment deeming participant unsuitable for the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Peking University Cancer Hospital

Beijing, Beijing Municipality, China, 100142

Actively Recruiting

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Research Team

Z

Zhaoqing Fan, MD

CONTACT

L

Lize Wang, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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