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

Not Applicable

Conditions: Neoplasms

Registration Number: KCT0008470

Lead Sponsor: Comprehensive & Integrative Medicine Institute

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot yet recruiting

Sex: Female

Target Recruitment: 20

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

•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:
oReport of mild”, moderate”, severe”, very severe” on the Severity Item on PRO-CTCAE CIPN assessment
oReport 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

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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