Chinese Medicinal Component Relieves CIPN and Mitochondria Function

NCT07693374 | Withdrawn

• 1 other identifier: TMANH111-REC005(TR)
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Breast Cancer; Chemotherapy-induced Peripheral Neuropathy (CIPN)

Keywords

chemotherapy-induced peripheral neuropathy; paclitaxel; Moutan Cortex; neuropathic pain

Outcome Measures

Primary Outcomes (1)

• BPI-SF;the Brief Pain Inventory-Short Form

  The primary endpoint was the mean of mean change in the average pain severity between groups. The two arms will measure the average pain severity score of the Brief Pain Inventory-Short Form24 (BPI-SF) at the 4th week. The BPI-SF average pain severity score uses a 0-10 scale for subject ratings. The items range from 0 to 10 (0 = no pain; 10 = worst pain). The higher the pain severity scores, the worse the degree of pain experienced by the patient. The BPI-SF also measures the pain interference on seven daily functions during the past 24 h, including general activities, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Using numeric scales, the items range from 0 to 10 (0 = no interference; 10= interferes completely). This study will measure the average pain severity and seven pain interference domains for eligible participants.

  BPI-SF will be assessed at the end of chemotherapy (baseline; the 0 week), and at the end of intervention (the 4th week)

Secondary Outcomes (2)

• SWM

  SWM will be assessed at the end of chemotherapy (baseline; the 0 week), and at the end of intervention (the 4th week)

• The 13-item FACT/GOG-Ntx subscale

  FACT/GOG-Ntx subscale will be assessed at the end of chemotherapy (baseline; the 0 week), and at the end of intervention (the 4th week)

Study Arms (2)

Moutan cortex group

EXPERIMENTAL

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.

Drug: Moutan cortex

Sham Moutan cortex group

SHAM COMPARATOR

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.

Drug: sham moutan cortex

Interventions

Moutan cortex DRUG

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).

Moutan cortex group

sham moutan cortex DRUG

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.

Sham Moutan cortex group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• China Medical University, Taiwan: collaborator
• Taiwan Municipal An-Nan Hospital-China Medical University: lead

Study Sites (1)

An Nan Hospital, China Medical University

Tainan, Taiwan, 709, Taiwan

Location

Related Publications (3)

• Hirai 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 BACKGROUND

• Hu 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 BACKGROUND

• Wang 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 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Neuralgia

Interventions

moutan cortex

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., PhD

Study Record Dates

• First Submitted: July 3, 2026
• First Posted: July 9, 2026
• Study Start: August 1, 2022
• Primary Completion: August 30, 2025
• Study Completion: August 30, 2025
• Last Updated: July 9, 2026

Record last verified: 2026-07

Locations

TW (1)