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

Comprehensive & Integrative Medicine Institute0 个研究点目标入组 20 人开始时间: 待定最近更新: 2023年5月30日

适应症

试验速览

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•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

•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

发起方

Comprehensive & Integrative Medicine Institute