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

NCT07626528 | Not Yet Recruiting Early Phase 1 DMC

• 1 other identifier: NCC6157
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chemotherapy-induced Peripheral Neuropathy

Outcome Measures

Primary Outcomes (1)

• 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).

  At baseline (before treatment), Day 21, and Day 42.

Secondary Outcomes (4)

• Improvement rate of EORTC Quality of Life - Chemotherapy-Induced Peripheral Neuropathy（EORTC QLQ-CIPN20）scores.

  At baseline (before treatment), Day 21, and Day 42.

• Remission rate of neuropathic pain assessed by Douleur Neuropathique 4 questions(DN4).

  At baseline (before treatment), Day 21, and Day 42.

• Reduction rate of TCM syndrome scores.

  At baseline (before treatment), Day 21, and Day 42.

• Numbness distribution and symptom severity scores.

  At baseline (before treatment), Day 21, and Day 42.

Study Arms (4)

Decotion

EXPERIMENTAL

Wenyang Tongbi Granules

Drug: Wenyang Tongbi Granules and Placebo mecobalamin

Placebo of decotion

PLACEBO COMPARATOR

Wenyang Tongbi Granules Placebo

Drug: Mecobalamin with placebo Wenyang Tongbi Granules

comparator

ACTIVE COMPARATOR

Mecobalamin

Drug: Mecobalamin with placebo Wenyang Tongbi Granules

Placebo of Mecobalamin

PLACEBO COMPARATOR

Placebo of Mecobalamin

Drug: Wenyang Tongbi Granules and Placebo mecobalamin

Interventions

Wenyang Tongbi Granules and Placebo mecobalamin DRUG

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

Decotion; Placebo of Mecobalamin

Mecobalamin with placebo Wenyang Tongbi Granules DRUG

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.

Placebo of decotion; comparator

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, 100021, China

Location

MeSH Terms

Interventions

mecobalamin

Central Study Contacts

YIN Yukun

CONTACT

010-87788030; qiuque20210303@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician

Study Record Dates

• First Submitted: May 25, 2026
• First Posted: June 4, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): November 1, 2028
• Last Updated: June 4, 2026

Record last verified: 2026-06

Locations

CN (1)