Hand and Foot Bath for Taxane-Induced Peripheral Neurotoxicity

Официальное название

A Randomized Controlled Single-Center Clinical Trial of Traditional Chinese Medicine Hand and Foot Bath for Taxane-Induced Peripheral Neurotoxicity

Обзор

Chemotherapy-induced peripheral neuropathy (CIPN) is a common and dose-limiting toxicity of taxane-based agents, with an incidence of 57%-83%. Patients frequently develop fingertip numbness, reduced tactile sensation, and other neuropathic symptoms, which significantly impair quality of life. The severity of CIPN is strongly associated with cumulative drug dosage. Current management strategies remain inadequate, and no high-level clinical recommendations are available. Traditional Chinese medicine (TCM) hand and foot baths have been widely applied in clinical practice due to their convenience, low cost, and high patient acceptance. The formula "Yi-Qi Yang-Xue Tong-Luo Fang," developed by the TCM Department of our hospital. Preliminary clinical use has shown reliable efficacy and good tolerability, suggesting potential benefit for CIPN. This randomized, controlled clinical trial aims to evaluate the efficacy and safety of the TCM hand and foot bath compared with methylcobalamin (a commonly used neurotrophic agent) for paclitaxel-induced CIPN. Peripheral neurotoxicity will be assessed using standardized measures, including the Common Terminology Criteria for Adverse Events (CTCAE), the Total Neuropathy Score-clinical version (TNSc), and the M. D. Anderson Symptom Inventory with TCM module (MDASI-TCM). Changes in scores between groups will be compared to determine relative effectiveness. Quality of life will be evaluated using validated international scales, specifically the EORTC Quality of Life Questionnaire for Breast Cancer Patients (EORTC QLQ-BR23) and the core questionnaire (EORTC QLQ-C30). These tools will provide multidimensional evaluation of treatment impact on daily functioning and well-being. The study is expected to generate evidence on both efficacy and safety of this TCM formula, clarify its potential role in preventing or reducing CIPN progression, and assess its influence on patients' quality of life. The findings will provide clinical data to support TCM-based interventions as complementary strategies for managing chemotherapy-induced neurotoxicity.

Вмешательства

• Препарат Traditional Chinese medicine (TCM) hand and foot baths
  Traditional Chinese medicine (TCM) formula "Yi-Qi Yang-Xue Tong-Luo Fang" hand and foot baths
• Препарат Methylcobalamin (methylB12)
  methylcobalamin is a commonly used neurotrophic agent in CIPN

Первичные конечные точки

• Proportion of Participants With Controlled Peripheral Neurotoxicity at Week 6 as Assessed by CTCAE v5.0 [Срок оценки: From baseline (within 7 days before the first administration of study drug) to 6 weeks ±7 days after treatment initiation; assessments will continue every 6 weeks until 6 weeks after the last cycle of taxane chemotherapy.]
• Proportion of Participants With Controlled Peripheral Neurotoxicity at Week 6 Assessed by the MD Anderson Symptom Inventory-Traditional Chinese Medicine Module (MDASI-TCM) [Срок оценки: From baseline (within 7 days before the first administration of study drug) to 6 weeks ±7 days after treatment initiation; assessments will continue every 6 weeks until 6 weeks after the last cycle of taxane chemotherapy.]
• Proportion of Participants With Controlled Peripheral Neurotoxicity at Week 6 as Assessed by Total Neuropathy Score-Clinical Version (TNSc) [Срок оценки: From baseline (within 7 days before the first administration of study drug) to 6 weeks ±7 days after treatment initiation; assessments will continue every 6 weeks until 6 weeks after the last cycle of taxane chemotherapy.]

Вторичные конечные точки (3)

• Time to Peripheral Neurotoxicity Progression as Assessed by CTCAE v5.0 [Срок оценки: From the first administration of study drug to the date of first documented neurotoxicity progression, as assessed by CTCAE criteria, up to 6 weeks after the last cycle of taxane chemotherapy.]
• Change from Baseline in Quality of Life Scores (EORTC QLQ-C30 and QLQ-BR23) [Срок оценки: From baseline (within 7 days before treatment initiation) to every 2 chemotherapy cycles, until 6 weeks after the last taxane chemotherapy.]
• Incidence of Adverse Events [Срок оценки: From the first administration of study drug to 6 weeks after the last taxane chemotherapy cycle.]

Критерии участия

Критерии включения

• Pathologically confirmed breast cancer;
• Development of grade ≥1 peripheral neurotoxicity after receiving a taxane-containing regimen, with continuation of this regimen for at least two additional cycles;
• Age ≥18 years, male or female;
• ECOG performance status score 0-1;
• Adequate major organ function (cardiac, hepatic, renal, and bone marrow) within 7 days before treatment, meeting the following requirements:

• Hematology (without blood transfusion within the previous 14 days):
• Hemoglobin (Hb) ≥90 g/L;
• Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L;
• Platelets (PLT) ≥75 × 10⁹/L.
• Biochemical tests:

• Total bilirubin (TBIL) ≤1.5 × upper limit of normal (ULN);
• ALT and AST ≤2.5 × ULN;
• Serum creatinine (Cr) ≤1.5 × ULN or creatinine clearance (CCr) ≥60 mL/min.
• Estimated survival ≥6 months;
• Signed informed consent.

Критерии исключения

• Pre-existing neurological disorders, including peripheral or central neuropathy;
• Known allergy to components of the investigational TCM formula;
• Neuropathy caused by electrolyte imbalance, diabetes, or other metabolic diseases;
• Neuropathy due to nerve compression of any cause;
• Concomitant use of other neuroprotective therapies (e.g., nerve growth factor, vitamin B, calcium-magnesium preparations);
• Pregnant or lactating women;
• Cognitive impairment or psychiatric disorders;
• Any other condition considered unsuitable by the investigator.

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

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07344974 · 2025YJZ98

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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