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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-Ī±), before and after the intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Decotion | Experimental | Wenyang Tongbi Granules |
|
| Placebo of decotion | Placebo Comparator | Wenyang Tongbi Granules Placebo |
|
| comparator | Active Comparator | Mecobalamin |
|
| Placebo of Mecobalamin | Placebo Comparator | Placebo of Mecobalamin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 Ć100% 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement rate of EORTC Quality of Life - Chemotherapy-Induced Peripheral Neuropathyļ¼EORTC QLQ-CIPN20ļ¼scores. | The improvement rate was calculated using the formula: (Post-treatment score-Pre-treatment scoreĆ100%)/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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| YIN Yukun | Contact | 010-87788030 | qiuque20210303@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College | Beijing | Beijing Municipality | 100021 | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 20, 2026 | Jun 2, 2026 |
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| 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. |
|
| Remission rate of neuropathic pain assessed by Douleur Neuropathique 4 questions(DN4). | 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 scoreĆ100%.The minimum value is 1 and maximum value is 10,the lower the better. | At baseline (before treatment), Day 21, and Day 42. |
| Reduction rate of TCM syndrome scores. | 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. | At baseline (before treatment), Day 21, and Day 42. |
| Numbness distribution and symptom severity scores. | 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. | At baseline (before treatment), Day 21, and Day 42. |
| Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 20, 2026 | Jun 2, 2026 | ICF_001.pdf |
| ID | Term |
|---|---|
| C019476 | mecobalamin |
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