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

Official title

Effectiveness of Cryotherapy Combined With Compression Therapy in Preventing Albumin-paclitaxel Induced Peripheral Neuropathy in Breast Cancer Patients

Overview

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.

Interventions

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

Primary outcome measures

• Incidence of grade 3 and higher peripheral neuropathy as assessed by NCI-CTCAE V5.0 [Time frame: 4 years]

Secondary outcome measures (8)

• Incidence of grade 2 and higher peripheral neuropathy as assessed by NCI-CTCAE V5.0 [Time frame: 4 years]
• Proportion of patients reporting level D and above based on the Patient Neurotoxicity Questionnaire (PNQ) [Time frame: 4 years]
• EORTC QLQ-CIPN20 [Time frame: 4 years]
• Incidence and severity of other adverse events as assessed by NCI-CTCAE V5.0 [Time frame: 4 years]
• Total pathological complete response (tpCR) rate [Time frame: Within 2 to 4 weeks after completion of neoadjuvant therapy]
• Breast pathological complete response (bpCR) rate [Time frame: Within 2 to 4 weeks after completion of neoadjuvant therapy]
• Objective response rate (ORR) [Time frame: After the last dose to before surgery or within 28 days]
• Invasive disease-free survival (IDFS) [Time frame: 3 years]

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;
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

China · 1 center

• Peking University Cancer Hospital — Beijing

Identifiers

NCT: NCT05341141 · BC-P30(FZQ)

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗