Multimodal Evaluation of Cryotherapy to Reduce Incidence of Chemotherapy-induced Peripheral Neurotoxicity in Breast Cancer Patients Treated With Paclitaxel Weekly
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 144
- 试验地点
- 4
- 主要终点
- Mean Change From Baseline in Total Neuropathy Score-Nurse Version (TNSn)
研究概览
简要总结
Female breast cancer patients receiving weekly paclitaxel-based chemotherapy are at risk of developing chemotherapy-induced peripheral neuropathy (CIPN), which may negatively affect quality of life and lead to treatment modifications or discontinuation. The aim of this clinical trial is to evaluate whether acral cryotherapy during chemotherapy administration can reduce the incidence and severity of CIPN.
Participants receiving cryotherapy will be compared with participants receiving standard care without cryotherapy. During chemotherapy treatment and throughout the first year of follow-up, all participants will undergo serial evaluations of peripheral nerve function, including neurological examinations, nerve conduction studies, patient-reported quality-of-life questionnaires, and blood tests. In addition to routine laboratory testing, extra blood samples will be collected at two time points to assess biomarkers of nerve damage.
详细描述
Female breast cancer patients receiving weekly paclitaxel-based chemotherapy are at risk of developing chemotherapy-induced peripheral neuropathy (CIPN), a frequent and potentially dose-limiting toxicity caused by damage to peripheral nerves. Symptoms of CIPN may persist long after treatment completion and can significantly impair quality of life and daily functioning.
The application of cold to the hands and feet during chemotherapy administration may reduce the incidence and severity of CIPN by decreasing local blood flow and limiting exposure of peripheral nerves to chemotherapy agents. The aim of this study is to evaluate whether continuous-flow cryotherapy at 15°C during weekly paclitaxel administration can reduce the incidence and severity of CIPN in breast cancer patients.
Participants receiving continuous-flow cryotherapy will be compared with participants receiving standard care without cryotherapy. During chemotherapy treatment and throughout the first year of follow-up, all participants will undergo serial assessments of peripheral nerve function, including neurological examinations, nerve conduction studies, patient-reported quality-of-life questionnaires, and laboratory testing. In addition to routine blood tests, extra blood samples will be collected at two time points to assess biomarkers associated with nerve damage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Paclitaxel weekly (80 mg/m2) at least 12 cycles (in adjuvant, neo-adjuvant setting or metastatic setting following the present schemes: TH (Paclitaxel, Trastuzumab), AC-TH (Doxorubicin, Cyclophosphamide, Paclitaxel, Trastuzumab), AC-THP (Doxorubicin, Cyclophosphamide, Paclitaxel, Trastuzumab, Pertuzumab), AC-T (Doxorubicin, Cyclophosphamide, Paclitaxel)
- •Eastern Cooperative Oncology Group Performance Status (ECOG) < 2
- •Female sex
- •Age: 18-90 years
- •written informed consent
排除标准
- •pre-existing motor/sensitive peripheral neuropathy
- •Endocrinopathies
- •presence of brain, bone, soft tissue, or skin of hands or feet metastases
- •Raynaud's syndrome
- •Peripheral arterial disease
- •hand and foot syndrome
- •any other reason that may hamper the data collection as assessed by the examiner
结局指标
主要结局
Mean Change From Baseline in Total Neuropathy Score-Nurse Version (TNSn)
时间窗: Baseline (before the first paclitaxel infusion) and 6 months after completion of paclitaxel treatment (approximately 9 months from baseline)
The Total Neuropathy Score-Nurse Version (TNSn) is a clinician-administered composite measure of chemotherapy-induced peripheral neuropathy. It comprises 5 items (sensory symptoms, motor symptoms, autonomic symptoms, pin-prick sensibility and vibration sensibility), each scored from 0 to 4 and summed to yield a total score ranging from 0 (minimum, no neuropathy) to 20 (maximum, most severe neuropathy); higher scores indicate a worse outcome. For each participant, the change from baseline is calculated as the TNSn total score at 6 months after completion of chemotherapy minus the TNSn total score at baseline. Positive values indicate worsening of neuropathy. The outcome is summarized per arm as the mean change with standard deviation.
次要结局
- Mean Change From Baseline in Peak-to-Peak Amplitude of the Dorsal Sural Sensory Nerve Action Potential (µV)(Baseline (before the first paclitaxel infusion), and 3, 6 and 12 months after completion of paclitaxel treatment (up to approximately 15 months from baseline))
- Mean Change From Baseline in Serum Neurofilament Light Chain (NfL) Concentration (pg/mL)(Baseline (before the first paclitaxel infusion), mid-chemotherapy (cycle 6, approximately 6 weeks))
- Mean Change From Baseline in Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) Subscale Score(Baseline, cycles 3, 6, 8, 10 and 12 (approximately 3, 6, 8, 10 and 12 weeks), and 3, 6 and 12 months after completion of paclitaxel treatment (up to approximately 15 months from baseline))