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NCT07693374
Chinese Medicinal Component Relieves CIPN and Mitochondria Function
Conditions: Breast Cancer, Chemotherapy-induced Peripheral Neuropathy (CIPN)
Sex: All
Ages: 20 Years – N/A
Healthy volunteers: No
Phase: NA
Sponsor: Taiwan Municipal An-Nan Hospital-China Medical University
Location: An Nan Hospital, China Medical University Tainan Taiwan
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07693374). StuddyBuddy aggregates publicly available trial information.