Status:
RECRUITING
Effectiveness of Cryotherapy Combined With Compression Therapy for Preventing Chemotherapy-induced Peripheral Neuropathy
Lead Sponsor:
Peking University
Collaborating Sponsors:
CSPC Ouyi Pharmaceutical Co., Ltd.
Conditions:
Breast Cancer
Eligibility:
FEMALE
20-70 years
Phase:
NA
Brief 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 ne...
Detailed Description
All HER-2 negative breast cancer patients received neoadjuvant chemotherapy with four cycles of dose-dense epirubicin and cyclophosphamide (ddEC) followed by four cycles of dose-dense albumin-paclitax...
Eligibility Criteria
Inclusion
- Female patients aged from 20 to 70 years old;
- Histologically confirmed as invasive breast cancer;
- HER-2 negative (defined by IHC 0 or 1+ ,or FISH negative);
- Participants who meet any of the following conditions: 1) T \> 2 cm, ER\<1% and PR\<1%; 2) T \> 2 cm, ER≥1% and biopsy pathology (FNAB or CNB) diagnosed regional lymph node metastasis;
- Without any previous treatment;
- ddEC-ddT neoadjuvant chemotherapy is planned;
- Participants must have at least one measurable disease according to RECIST 1.1;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- LVEF ≥ 50%;
- The ECG results are judged to be almost normal or normal, or the investigator judges that the abnormalities are not clinically significant;
- Bone marrow function: absolute neutrophil counts (ANC) ≥ 1.5x10\^9/L, platelets ≥ 100x10\^9/L, hemoglobin ≥ 90g/L;
- Liver and kidney function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) are both ≤2.5 ULN; serum total bilirubin and serum creatinine are both ≤ 1.5 ULN;
- Participants had good compliance with the planned treatment and follow-up, understood the study procedures of this study, and signed informed consent form.
Exclusion
- Breast cancer with distant metastasis;
- A history of other malignancies;
- In the past or present, participants with sensory or motor neurological diseases;
- Participants who are known to be allergic to the active or other components of the study treatment;
- Cerebral thrombosis is present;
- In the past and present, participants with severe cardiac disease or discomfort , including but not limited: 1) High-risk uncontrolled arrhythmia, atrial tachycardia (heart rate \> 100/min in resting state), significant ventricular arrhythmia (ventricular arrhythmia) or higher atrioventricular block (second-degree type 2 \[Mobitz 2\] atrioventricular block or third-degree atrioventricular block); 2) Angina pectoris requiring anti-angina medication; 3) Clinically significant valvular heart disease; 4) ECG showing transmural myocardial infarction; 5) ncontrolled hypertension (eg systolic blood pressure \> 180mm Hg or diastolic blood pressure \> 100mmHg); 6) Myocardial infarction; 7) Congestive heart failure;
- Participants have the following serious illnesses or medical conditions, including but not limited: 1) History of serious neurological or psychiatric disorders, including psychosis, dementia, or epilepsy, that prevent understanding and informed consent; 2) Active uncontrolled infection; 3) Active pepticulcer, unstable diabetes;
- Participants who are pregnant, breastfeeding, or refuse to use adequate contraception prior to study entry and for the duration of study participation;
- Participants who were judged by the investigator to be unsuitable for this study.
Key Trial Info
Start Date :
June 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT05341141
Start Date
June 10 2022
End Date
November 1 2026
Last Update
June 13 2022
Active Locations (1)
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1
Peking University Cancer Hospital
Beijing, Beijing Municipality, China, 100142