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Clinical Trials in China / NCT05341141
Recruiting Not applicable

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

NCT05341141 · tracked via the Priya Life Science China tracker
Sponsor
Peking University
Phase
Not applicable
Started
2022-06-10
Last updated
2022-06-13

Condition(s) studied

Breast Cancer

Investigational drug(s) / intervention(s)

Frozen glove and sockddEC-ddT

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

ddEC-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.

Study 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
FEMALE
Min age
20 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: 1. Female patients aged from 20 to 70 years old; 2. Histologically confirmed as invasive breast cancer; 3. HER-2 negative (defined by IHC 0 or 1+ ,or FISH negative); 4. 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; 5. Without any previous treatment; 6. ddEC-ddT neoadjuvant chemotherapy is planned; 7. Participants must have at least one measurable disease according to RECIST 1.1; 8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; 9. LVEF ≥ 50%; 10. The ECG results are judged to be almost normal or normal, or the investigator judges that the abnormalities are not clinically significant; 11. Bone marrow function: absolute neutrophil counts (ANC) ≥ 1.5x10\^9/L, platelets ≥ 100x10\^9/L, hemoglobin ≥ 90g/L; 12. 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; 13. Participants had good compliance with the planned treatment and follow-up, understood the study procedures of this study, and signed informed consent form. Exclusion Criteria: 1. Breast cancer with distant metastasis; 2. A history of other malignancies; 3. In the past or present, participants with sensory or motor neurological diseases; 4. Participants who are known to be allergic to the active or other components of the study treatment; 5. Cerebral thrombosis is present; 6. 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; 7. 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; 8. Participants who are pregnant, breastfeeding, or refuse to use adequate contraception prior to study entry and for the duration of study participation; 9. Participants who were judged by the investigator to be unsuitable for this study.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Peking University Cancer Hospital Beijing Beijing Municipality Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05341141 on ClinicalTrials.gov ↗ ← All trials in China