Effectiveness of Cryotherapy Combined With Compression Therapy in Preventing Albumin-paclitaxel Induced Peripheral Neuropathy in Breast Cancer Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 102
- Locations
- 1
- Primary Endpoint
- Incidence of grade 3 and higher peripheral neuropathy as assessed by NCI-CTCAE V5.0
Study Overview
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 neuropathy.
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-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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 70 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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.
Arms & Interventions
ddEC-ddT and cryotherapy combined with compression
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.
Intervention: Frozen glove and sock (Device)
ddEC-ddT and cryotherapy combined with compression
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.
Intervention: ddEC-ddT (Drug)
ddEC-ddT
ddEC-ddT will be administered without cryotherapy combined with compression.
Intervention: ddEC-ddT (Drug)
Outcomes
Primary Outcomes
Incidence of grade 3 and higher peripheral neuropathy as assessed by NCI-CTCAE V5.0
Time Frame: 4 years
Incidence of grade 3 and higher peripheral neuropathy as assessed by NCI-CTCAE V5.0
Secondary Outcomes
- Total pathological complete response (tpCR) rate(Within 2 to 4 weeks after completion of neoadjuvant therapy)
- Objective response rate (ORR)(After the last dose to before surgery or within 28 days)
- Proportion of patients reporting level D and above based on the Patient Neurotoxicity Questionnaire (PNQ)(4 years)
- Incidence and severity of other adverse events as assessed by NCI-CTCAE V5.0(4 years)
- Breast pathological complete response (bpCR) rate(Within 2 to 4 weeks after completion of neoadjuvant therapy)
- Invasive disease-free survival (IDFS)(3 years)
- Incidence of grade 2 and higher peripheral neuropathy as assessed by NCI-CTCAE V5.0(4 years)
- EORTC QLQ-CIPN20(4 years)
Investigators
Tao OUYANG
Director of Breast Center of Peking University Cancer Hospital
Peking University