Study of Wenyang Tongbi Formula in the Treatment of Chemotherapy-Induced Polyneuropathy
A Multicenter Evidence-Based Clinical Study on the Safety and Efficacy of Wenyang Tongbi Formula in the Treatment of Chemotherapy-Induced Polyneuropathy
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.
Přehled studie
Postavení
Typ studie
Zápis (Odhadovaný)
Fáze
- Raná fáze 1
Kontakty a umístění
Studijní kontakt
- Jméno: YIN Yukun
- Telefonní číslo: 010-87788030
- E-mail: qiuque20210303@163.com
Studijní místa
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Beijing Municipality
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Beijing, Beijing Municipality, Čína, 100021
- National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Trojnásobný
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Decotion
Wenyang Tongbi Granules
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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
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Komparátor placeba: Placebo of decotion
Wenyang Tongbi Granules Placebo
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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.
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Aktivní komparátor: comparator
Mecobalamin
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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.
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Komparátor placeba: Placebo of Mecobalamin
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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
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Overall Response Rate (ORR)
Časové okno: At baseline (before treatment), Day 21, and Day 42.
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The evaluation was conducted with reference to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE). The outcomes were classified into four categories: Complete Response (CR), Partial Response (PR), No Change (NC), and Progressive Disease (PD). The Overall Response Rate (ORR) was calculated as follows: ORR= Total number of cases Number of CR + PR cases ×100% Definitions: Complete Response (CR): Reduction of adverse event grade to Grade 1. Partial Response (PR): A decrease of at least one grade compared to baseline (pre-treatment). No Change (NC): No improvement in symptoms or signs; or minimal symptomatic improvement without corresponding sign improvement. Progressive Disease (PD): An increase of at least one grade compared to baseline (pre-treatment). |
At baseline (before treatment), Day 21, and Day 42.
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Improvement rate of EORTC Quality of Life - Chemotherapy-Induced Peripheral Neuropathy（EORTC QLQ-CIPN20）scores.
Časové okno: At baseline (before treatment), Day 21, and Day 42.
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The improvement rate was calculated using the formula: (Post-treatment score-Pre-treatment score×100%)/Pre-treatment score. This reflects the change in symptom burden and quality of life related to CIPN. The minimum value is 1 and maximum value is 4,the lower the better. |
At baseline (before treatment), Day 21, and Day 42.
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Remission rate of neuropathic pain assessed by Douleur Neuropathique 4 questions(DN4).
Časové okno: At baseline (before treatment), Day 21, and Day 42.
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Pain remission was evaluated using the Douleur Neuropathique 4 questions (DN4)questionnaire. The remission rate was calculated as: (Pre-treatment score-Post-treatment score)/Pre-treatment score×100%.The minimum value is 1 and maximum value is 10,the lower the better. |
At baseline (before treatment), Day 21, and Day 42.
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Reduction rate of TCM syndrome scores.
Časové okno: At baseline (before treatment), Day 21, and Day 42.
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According to the Guidelines for Clinical Research of New Traditional Chinese Medicines, the reduction rate was calculated based on the scoring criteria for "Yang Deficiency and Collateral Obstruction with Toxin-Stasis Accumulation Pattern".The minimum value is 1 and maximum value is 4,the lower the better.
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At baseline (before treatment), Day 21, and Day 42.
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Numbness distribution and symptom severity scores.
Časové okno: At baseline (before treatment), Day 21, and Day 42.
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A novel supplementary rating scale was developed by our research group based on existing clinical scales and has been submitted for a national invention patent (Application No. 202511273259.8).The minimum value is 1 and maximum value is 10,the lower the better.
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At baseline (before treatment), Day 21, and Day 42.
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Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- NCC6157
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