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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

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

Вторичные конечные точки (8)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Китай · 1 центр

• Peking University Cancer Hospital — Пекин

Идентификаторы

NCT: NCT05341141 · BC-P30(FZQ)

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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