Study of Wenyang Tongbi Formula in the Treatment of Chemotherapy-Induced Polyneuropathy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Wenyang Tongbi Granules and Placebo mecobalamin, Mecobalamin with placebo Wenyang Tongbi Granules.
- Who it may be relevant to
- Registry conditions: Chemotherapy-induced Peripheral Neuropathy. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multicenter Evidence-Based Clinical Study on the Safety and Efficacy of Wenyang Tongbi Formula in the Treatment of Chemotherapy-Induced Polyneuropathy
Overview
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.
Interventions
- Drug 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 - Drug 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.
Primary outcome measures
- Overall Response Rate (ORR) [Time frame: At baseline (before treatment), Day 21, and Day 42.]
Secondary outcome measures (4)
- Improvement rate of EORTC Quality of Life - Chemotherapy-Induced Peripheral Neuropathy（EORTC QLQ-CIPN20）scores. [Time frame: At baseline (before treatment), Day 21, and Day 42.]
- Remission rate of neuropathic pain assessed by Douleur Neuropathique 4 questions(DN4). [Time frame: At baseline (before treatment), Day 21, and Day 42.]
- Reduction rate of TCM syndrome scores. [Time frame: At baseline (before treatment), Day 21, and Day 42.]
- Numbness distribution and symptom severity scores. [Time frame: At baseline (before treatment), Day 21, and Day 42.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Uni — Beijing
Identifiers
NCT: NCT07626528 · NCC6157