Effectiveness of Cryotherapy Combined With Compression Therapy in Preventing Albumin-paclitaxel Induced Peripheral Neuropathy in Breast Cancer Patients
Overview
- Phase
- Not Applicable
- Intervention
- Frozen glove and sock
- Conditions
- Breast Cancer
- Sponsor
- Peking University
- Enrollment
- 102
- Locations
- 1
- Primary Endpoint
- Incidence of grade 3 and higher peripheral neuropathy as assessed by NCI-CTCAE V5.0
- Status
- Recruiting
- Last Updated
- 3 years ago
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.
Investigators
Tao OUYANG
Director of Breast Center of Peking University Cancer Hospital
Peking University
Eligibility Criteria
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;
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
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
ddEC-ddT
ddEC-ddT will be administered without cryotherapy combined with compression.
Intervention: ddEC-ddT
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)