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

Early Phase 1Not Yet RecruitingNCT07626528

Cancer Institute and Hospital, Chinese Academy of Medical Sciences144 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

144

Conditions

Chemotherapy-induced Peripheral Neuropathy

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Overall Response Rate (ORR)

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).