Preventing Chemotherapy-Induced Peripheral Neuropathy with Acupuncture, A Randomized Controlled Trial

Authors
Category Primary study
Registry of TrialsKorean Clinical Trials Database
Year 2023
INTERVENTION: Others(Acupuncture treatment) : The acupuncture arm will receive a standardized acupuncture protocol 1‐2 times a week for 12 weeks (a total of 14 sessions). The control arm will receive and watch videos with nature scenery with a relaxation exercise guide 1‐2 times a week for 12 weeks (a total of 14 sessions). CONDITION: Neoplasms PRIMARY OUTCOME: the change in severity of CIPN: the mean change from baseline (Week 12 – baseline) in the EORTC QLQ‐CIPN20 sensory score compared between the two randomized arms SECONDARY OUTCOME: Maximum CIPN score through the EORTC QLQ‐CIPN20 pain medication usage Pain, Sleep and Quality of Life: Changes relative to baseline in scores of pain intensity, the Pittsburgh Sleep Quality Inde X(PSQI), and in the total and subscales of the EORTC QLQ‐C30 the incidence of CIPN in the EORTC QLQ‐CIPN20 and PRO‐CTCAE CIPN ? all occurrences (AOCIPN) ? grade‐2 or above CIPN (G2CIPN) the incidence of early treatment discontinuation INCLUSION CRITERIA: • History of histologically proven stage I‐III breast cancer, without evidence of distant metastasis • Scheduled to receive adjuvant or neoadjuvant taxane‐based chemotherapy (with or without HER‐2 directed therapy or with or without immunotherapy). Patient must enroll before the second cycle of a taxane. • Age = 18 years • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 • Signed informed consent
Epistemonikos ID: 557ebcd4f135236ad4e14f22822052c63e5e82d9
First added on: Feb 20, 2024