Clinical Trial: A randomized controlled trial to evaluate the efficacy of acupuncture and moxibustion in patients with taxane-induced peripheral neuropathy after curative treatment for breast cancer (Japan)

Tokyo, Aug. 22 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062281) titled 'A randomized controlled trial to evaluate the efficacy of acupuncture and moxibustion in patients with taxane-induced peripheral neuropathy after curative treatment for breast cancer' on Aug. 22.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - No treatment

Primary Sponsor: Institute - National Cancer Center

Condition: Condition - chemotherapy-induced peripheral neuropathy Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - To evaluate the efficacy of acupuncture and moxibustion for chemotherapy-induced peripheral neuropathy in breast cancer survivors. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - acupuncture and moxibustion Interventions/Control_2 - wait-list control

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Female Key inclusion criteria - 1. Patients with pathologically confirmed stage 1-3 breast cancer who have completed curative treatment. 2. Patients who are at least 3 months post-curative treatment, have no evidence of metastatic or recurrent disease, and are under observation without anticancer treatment (patients receiving postoperative endocrine therapy, anti-HER2 therapy, or molecularly targeted therapy are permitted). 3. Patients with CIPN caused by taxane-based chemotherapy. 4. Patients whose CIPN symptoms are rated as mild or greater on PRO-CTCAE Item 39a. 5. Patients with neuropathic pain attributable to CIPN and an average pain intensity score of 4 or higher on the NRS during the previous 24 hours. 6. Patients aged 18 years or older. 7. ECOG PS 0 or 1. 8. Patients who have provided written informed consent to participate in this study. Key exclusion criteria - 1. Patients with peripheral neuropathy caused by factors other than taxane-based chemotherapy, such as severe edema, diabetes mellitus, postherpetic neuralgia, or vitamin B12 deficiency. 2. Patients with metastatic or recurrent disease at the time of enrollment. 3. Patients with fibromyalgia, inflammatory joint disease, or phantom limb pain. 4. Patients with psychiatric disorders, such as severe depression. 5. Patients with a history of acupuncture and moxibustion treatment for CIPN. 6. Patients receiving chemotherapy at the time of enrollment. 7. Patients with serious comorbidities. 8. Patients who are pregnant or breastfeeding. 9. Patients currently enrolled in a clinical trial or another study that may affect the results of this study. 10. Patients who are considered unsuitable for participation in this clinical trial by the investigator. Target Size - 94

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 07 Month 20 Day Anticipated trial start date - 2026 Year 09 Month 01 Day Last follow-up date - 2028 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071148

Disclaimer: Curated by HT Syndication.