Clinical trial · Interventional
Chinese Medicinal Component Relieves CIPN and Mitochondria Function
A Chinese Medicinal Component Relieves the Chemotherapy-induced Peripheral Neuropathy and the Relating Changes of Mitochondria Function in Dorsal Root Ganglion: Basic and Clinical Research
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Initial prep showed that formulation, QC, and cost for high-dose paeonol/Cortex Moutan exceeded the budget. Also, recruiting patients with chemotherapy-induced peripheral neuropathy was limited. To ensure safety, enrollment did not officially launch.
Summary
Brief summary (as posted)
A randomized controlled trial was designed and conducted to confirm whether oral administration of the herb Moutan Cortex, which contains paeonol, can alleviate peripheral neuropathy in paclitaxel-treated cancer patients. This research project will validate our new preliminary findings demonstrating the neuroprotective effects after paclitaxel treatment. Importantly, our data are expected to elucidate the way Moutan Cortex induces neuroprotection in the clinical setting and provide a scientific basis for the development of new approaches to treat CIPN.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Chemotherapy-induced Peripheral Neuropathy (CIPN) | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Moutan cortex | Drug | — | UNRESOLVED |
| sham moutan cortex | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Moutan cortex group
- description
- Moutan Cortex, the certified pharmaceutical name is "Moutan radices extract power". The purchased powder is manufactured by Sheng Chang Pharmaceutical Co. Ltd., Taoyuan, Taiwan (No. 0714A) and standardized with a standard product of Moutan Cortex certified by Taiwan Food and Drug Administration (certified no. 003053). Each participant will intake moutan cortex 2g/day daily for 4 weeks.
- interventionNames
- Drug: Moutan cortex
- type
- SHAM_COMPARATOR
- label
- Sham Moutan cortex group
- description
- The sham Moutan cortex powder will also be manufactured by Sheng Chang Pharmaceutical Co. Ltd., Taoyuan, Taiwan. Each participant will intake sham moutan cortex 2g/day daily for 4 weeks.
- interventionNames
- Drug: sham moutan cortex
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * adult women above 20 years, diagnosed with stage I-III breast cancer by a histological analysis, and who had completed adjuvant or neoadjuvant neurotoxic chemotherapy (including taxane-based or platinum-based), with the severity of CIPN matching the definition of the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) 4.0 version more than grade 1. In addition, the patients' daily physical status will match the definition of the Eastern Cooperative Oncology Group (ECOG) performance status less than grade 3 Exclusion Criteria: * metastatic breast cancer, a history of diabetic neurological disease before chemotherapy, other pre-existing peripheral neurological disorders, a history of inflammatory or metabolic arthritis, severe coagulopathy or potential bleeding tendency, dermatological disease within acupuncture needling area. Concomitant use of selected analgesics was allowed23 (e.g.,opioids, acetaminophen, aspirin, non-steroidal anti-inflammatory drugs \[NSAIDs\]), but only patients receiving stable doses in the two weeks prior to randomization could participate: 1) no new analgesics were added; 2) no analgesics were discontinued; and 3) the weekly 24-hour total analgesic dose did not fluctuate up or down by \> 10% in the two weeks prior to study registration
References
Publications (3)
- BACKGROUNDHirai A, Terano T, Hamazaki T, Sajiki J, Saito H, Tahara K, Tamura Y, Kumagai A. Studies on the mechanism of antiaggregatory effect of Moutan Cortex. Thromb Res. 1983 Jul 1;31(1):29-40. doi: 10.1016/0049-3848(83)90005-1. PMID 6412397
- BACKGROUNDHu LY, Mi WL, Wu GC, Wang YQ, Mao-Ying QL. Prevention and Treatment for Chemotherapy-Induced Peripheral Neuropathy: Therapies Based on CIPN Mechanisms. Curr Neuropharmacol. 2019;17(2):184-196. doi: 10.2174/1570159X15666170915143217. PMID 28925884
- BACKGROUNDWang Z, He C, Peng Y, Chen F, Xiao P. Origins, Phytochemistry, Pharmacology, Analytical Methods and Safety of Cortex Moutan (Paeonia suffruticosa Andrew): A Systematic Review. Molecules. 2017 Jun 7;22(6):946. doi: 10.3390/molecules22060946. PMID 28590441