None listed
Conditions
Interventions
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 vid
Sponsors
Comprehensive & Integrative Medicine Institute
Eligibility
Sex/Gender
Female
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: • Previous receipt of CIPN-inducing chemotherapy agents (1 prior cycle of a taxane is allowed). • Unstable cardiac disease or myocardial infarction within 6 months prior to study entry • Wearing a pacemaker or implantable cardioverter-defibrillator • Uncontrolled seizure disorder • History of pre-existing peripheral neuropathy • Use of acupuncture within the 3 months prior to study enrollment • Self-report of any CIPN symptoms via staff-administered PRO-CTCAE CIPN, defined as either: o Report of “mild”, “moderate”, “severe”, “very severe” on the Severity Item on PRO-CTCAE CIPN assessment o Report of “a little bit”, “somewhat”, “quite a bit”, “very much” on the Interfere Item on PRO-CTCAE CIPN assessment * We will not include members of any of the following special populations: • Adults unable to consent • Individuals who are not yet adults (infants, children, teenagers < 18 years) • Pregnant women • Prisoners
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| the incidence of CIPN in the EORTC QLQ-CIPN20 and PRO-CTCAE CIPN ? all occurrences (AOCIPN) ? grade-2 or above CIPN (G2CIPN);Maximum CIPN score through the EORTC QLQ-CIPN20 ;Pain, Sleep and Quality of Life: Changes relative to baseline in scores of pain intensity, the Pittsburgh Sleep Quality Index (PSQI), and in the total and subscales of the EORTC QLQ-C30 ;pain medication usage ;the incidence of early treatment discontinuation | — |
Countries
Korea, Republic of
Contacts
Public ContactYoung Ju Jeong
Daegu Catholic University Medical Center
Outcome results
None listed