Electroacupuncture Plus Auricular Acupressure on Chemotherapy-Related Insomnia in Patients With Breast Cancer (EACRI): Study Protocol for a Randomized, Sham-Controlled Trial

Abstract

Objective Insomnia is a highly prevalent and disturbing symptom in breast cancer patients under or post chemotherapy. If not appropriately treated, it can persist for years after the completion of cancer treatments. Acupuncture has been widely used for alleviating insomnia. The aim of this study is to examine the feasibility, efficacy and safety of acupuncture for chemotherapy-related insomnia among patients with breast cancer. Materials and Methods This is a trial protocol for a randomized, sham-controlled, subject- and assessor-blinded clinical trial. A total of 138 eligible participants will be assigned randomly to acupuncture or sham control group at a ratio of 1:1. Participants in acupuncture group will receive electroacupuncture (EA) plus auricular acupressure (AA) treatment, while subjects in sham acupuncture group will receive sham EA plus sham AA. Both acupuncture and sham treatments will be given twice weekly for 6 weeks, followed by maintenance treatments once every 4 weeks for 12 weeks (15 sessions totally). The primary outcome is the change of Insomnia Severity Index score between baseline and the end of 6-week treatment. Secondary outcome measurements include Actiwatch, sleep diary, Pittsburgh Sleep Quality Index, Functional Assessment of Cancer Therapy-Breast Cancer, Hospital Anxiety and Depression Scale, Brief Pain Inventory-Short Form, Brief Fatigue Inventory, Acupuncture Expectancy Scale, credibility, and adverse events. Participants will be followed up to 42 weeks. Conclusions This trial will expand our understanding of the feasibility, efficacy, and safety of acupuncture as a treatment for alleviating chemotherapy-related insomnia in patients with breast cancer. EA plus AA, if proven to be effective, can be implemented into routine settings to play a role in insomnia management for patients with breast cancer.

Acupuncture for chemotherapy-associated insomnia in breast cancer patients: an assessor-participant blinded, randomized, sham-controlled trial

“…The training workshop included introduction of treatment protocol, standard procedures of active and sham acupuncture, and conversation skills with participants. The treatment protocol [ 26 ] was developed based on neuroanatomic mechanisms [ 27 , 28 ], CMPs’ experience and previous clinical trials [ 21 , 29 ]. Participants received a total of 15 sessions of treatments, with 12 sessions given twice weekly as intensive treatment over the first 6 consecutive weeks, 3 sessions given once every 4 weeks from 7 to 18 weeks to maintain treatment effects, and follow-up from 19 to 42 weeks.…”

“…Details of outcomes have been reported previously [ 26 ]. The primary outcome was defined as the change in ISI score at 6 weeks of treatment from baseline.…”

Role of Chinese Acupuncture in the Treatment for Chemotherapy-Induced Cognitive Impairment in Older Patients With Cancer: Protocol for a Randomized Controlled Trial

“…Each item is scored on a 0 to 4 scale, and the sum of all 5 subscales ranges from 0 to 144. A higher score indicates a better QoL [12].…”

“…Acupuncture has been used for thousands of years in China and other Asian countries to treat various diseases, including sleep disturbance [12]. It is a nonpharmacological therapy that involves inserting needles into acupuncture points and sometimes applying minielectrical current stimulation on acupuncture points via needles or applying acupressure on the surface of points in different parts of the body, including ear and scalp [12]. Electroacupuncture (EA) is an effective family member of combo acupoint stimulation [13].…”