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

Peking University

Status: Enrolling

Conditions: Breast Cancer

Treatments: Drug: ddEC-ddT; Device: Frozen glove and sock

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05341141

BC-P30(FZQ)

Details and patient eligibility

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.

Full 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-paclitaxel (ddT). The patients were randomly assigned in a 1:1 ratio to receive cryotherapy combined with compression or no intervention. The primary endpoint was incidence of grade 3 and higher peripheral neuropathy as assessed by NCI-CTCAE V5.0.

Enrollment: 102 estimated patients

Sex: Female

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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102 participants in 2 patient groups

ddEC-ddT and cryotherapy combined with compression

Experimental group

Description:

Cryotherapy will be applied using a frozen glove and sock for 15 minutes before, during and 15 minutes after each albumin-paclitaxel infusion. Compression therapy will be applied using a surgical glove for 30 minutes before, during and 30 minutes after each albumin-paclitaxel infusion.

Treatment:

Drug: ddEC-ddT

Device: Frozen glove and sock

ddEC-ddT

Other group

Description:

ddEC-ddT will be administered without cryotherapy combined with compression.

Treatment:

Drug: ddEC-ddT