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Набор скоро начнётся NCT07626528

Study of Wenyang Tongbi Formula in the Treatment of Chemotherapy-Induced Polyneuropathy

Ранняя фаза I С лечением Chemotherapy-induced Peripheral Neuropathy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Wenyang Tongbi Granules and Placebo mecobalamin, Mecobalamin with placebo Wenyang Tongbi Granules.
Кому может быть актуально
Состояния в реестре: Chemotherapy-induced Peripheral Neuropathy. Базовые параметры: 18 лет — 80 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
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Официальное название

A Multicenter Evidence-Based Clinical Study on the Safety and Efficacy of Wenyang Tongbi Formula in the Treatment of Chemotherapy-Induced Polyneuropathy

Обзор

This clinical trial aims to evaluate the efficacy of Wenyang Tongbi Granules (a patented Traditional Chinese Medicine prescription) in treating chemotherapy-induced peripheral neuropathy (CIPN). The study compares Wenyang Tongbi Granules with mecobalamin tablets, a standard clinical medication, to determine whether the TCM intervention yields superior outcomes in sensory and motor function of the limbs, as well as overall systemic status, among patients presenting with paresthesia and pain during chemotherapy. Methods: Participants who develop hand-foot paresthesia or pain during chemotherapy will receive either Wenyang Tongbi Granules or mecobalamin tablets daily for a continuous period of 42 days. Evaluations will be conducted on Day 1, Day 21, and Day 42. Outcome measures include the severity and duration of limb paresthesia, as well as changes in TCM-specific syndromes. Additionally, blood samples will be collected to assess variations in serum levels of multiple cytokines, including interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-α), before and after the intervention.

Вмешательства

  • Препарат Wenyang Tongbi Granules and Placebo mecobalamin
    Placebo mecobalamin, one capsule per administration, three times daily (tid) with Wenyang Tongbi Granules (10 g/bag), administered as three bags per day for 42 consecutive days
  • Препарат Mecobalamin with placebo Wenyang Tongbi Granules
    Mecobalamin (one capsule) administered three times daily (tid), combined with placebo Wenyang Tongbi Granules containing 5% of the original formula concentration (10 g/bag), administered as three bags per day for 42 consecutive days.

Первичные конечные точки

  • Overall Response Rate (ORR) [Срок оценки: At baseline (before treatment), Day 21, and Day 42.]
Вторичные конечные точки (4)
  • Improvement rate of EORTC Quality of Life - Chemotherapy-Induced Peripheral Neuropathy（EORTC QLQ-CIPN20）scores. [Срок оценки: At baseline (before treatment), Day 21, and Day 42.]
  • Remission rate of neuropathic pain assessed by Douleur Neuropathique 4 questions(DN4). [Срок оценки: At baseline (before treatment), Day 21, and Day 42.]
  • Reduction rate of TCM syndrome scores. [Срок оценки: At baseline (before treatment), Day 21, and Day 42.]
  • Numbness distribution and symptom severity scores. [Срок оценки: At baseline (before treatment), Day 21, and Day 42.]

Критерии участия

Критерии включения

  • Age: Patients aged between 18 and 80 years (inclusive).
  • Life Expectancy: An anticipated survival time of ≥ 3 months.
  • Performance Status \& Organ Function: A Karnofsky Performance Status (KPS) score ≥ 60 and adequate organ function.
  • Diagnosis: Histopathologically or cytologically confirmed breast cancer or colorectal cancer.
  • Chemotherapy Regimen: Currently undergoing chemotherapy containing taxanes or oxaliplatin.
  • Neurotoxicity Grade: Presence of Grade ≥ 2 peripheral neurotoxicity (according to NCI-CTCAE criteria) induced by chemotherapy.
  • TCM Syndrome Differentiation: Conforming to the "Yang Deficiency and Collateral Obstruction with Toxin-Stasis Accumulation Pattern" as defined in the Guidelines for Clinical Research of New Traditional Chinese Medicines.

Критерии исключения

  • Allergy History: Known hypersensitivity to the active ingredients or excipients of the study drug/placebo; history of allergic constitution; or a history of allergies to ≥ 3 substances.
  • Comorbidities: Presence of severe psychiatric disorders; or pre-existing conditions such as diabetic neuropathy, hypothyroidism, renal insufficiency, radiculopathy, Charcot-Marie-Tooth disease, or Guillain-Barré syndrome.
  • Concomitant Medications: Use of Chinese patent medicines or herbal decoctions specifically for CIPN within 30 days prior to enrollment.
  • Compliance: Inability to adhere to the treatment protocol or difficulty in accurately assessing one's own general condition.
  • Pregnancy \& Lactation: Pregnant or lactating women.

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
Тройное слепое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Uni — Пекин

Идентификаторы

NCT: NCT07626528 · NCC6157

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗