Electroacupuncture for Chemotherapy-Related Cognitive Impairment

Electroacupuncture to Prevent Chemotherapy-Related Cognitive Impairment in Patients With Breast Cancer

The objective of this trial is to evaluate the effect of electroacupuncture compared to sham acupuncture in preventing CRCI among breast cancer patients scheduled to undergo chemotherapy.

Study Overview

• Status: Not yet recruiting
• Conditions: Chemotherapy-Related Cognitive Impairment
• Intervention / Treatment: Device: Electroacupuncture; Device: Sham acupuncture

Detailed Description

Participants will be randomized to receive either acupuncture or sham acupuncture treatment. Both treatments will be administered twice a week, starting one week before chemotherapy and continuing throughout the chemotherapy period. The study outcomes will be evaluated at three time points: baseline (before acupuncture and chemotherapy), during chemotherapy (one day before the third chemotherapy cycle), after chemotherapy (21 days after the last chemotherapy cycle). Each cycle typically lasts for 4 weeks.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Shiyan Yan, PhD; Phone Number: +86-10-64287525; Email: yanshiyan@bucm.edu.cn
• Study Contact Backup: Name: Zhiyi Xiong, MM; Phone Number: +86 18811022104; Email: zhiyixiong@foxmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Newly diagnosed with stage I-III breast cancer
2. Scheduled to undergo chemotherapy
3. Aged between 18 and 75 years
4. MoCA score ≥ 26
5. Voluntary agreement to participate in the study and sign an informed consent

Exclusion Criteria:

1. Demonstrated tumor metastasis or recurrence
2. Had a prior history of chemotherapy
3. Reported a history of brain tumors, head trauma or stroke
4. Were diagnosed with cognitive function-impaired disorders, such as Alzheimer's disease
5. Were unable to cooperate with testing for any reasons
6. Had severe hepatic or renal insufficiency
7. Had hemorrhagic disorders, including von Willebrand disease, or were taking anticoagulant or antiplatelet medication
8. Had an implanted cardiac pacemaker
9. Had a history of alcohol abuse or drug addiction
10. Were participating in another interventional trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Electroacupuncture; After skin disinfection, acupuncture needles will be inserted into the acupoints. All needles will be manipulated to achieve deqi. Then, an electroacupuncture apparatus will be connected. The stimulation parameters will be continuous wave, 2 Hz, and the current intensity will be adjusted according to the participant's comfort level.	Device: Electroacupuncture; Participants in the electroacupuncture group will receive electroacupuncture twice a week, with each session lasting 30 minutes. The treatment will start one week before chemotherapy and continue throughout the chemotherapy period.
Sham Comparator: Sham acupuncture; After skin disinfection, acupuncture needles will be inserted into acupoints that are unrelated to the treated syndromes. The needles will be inserted to a depth of 3 to 5 mm, without any manipulation or deqi. Then, the electronic acupuncture apparatus will be connected, with a continuous wave of 2 Hz. However, the intensity of electrical stimulation will be set to a minimum level that participants can perceive, and the apparatus will be turned off after 30 seconds of stimulation.	Device: Sham acupuncture; Participants in the sham acupuncture group will receive minimal acupuncture twice a week, with each session lasting 30 minutes. The treatment will start one week before chemotherapy and continue throughout the chemotherapy period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of chemotherapy-related cognitive impairment (CRCI) at the end of chemotherapy	All participants will undergo neuropsychological assessments at baseline and after chemotherapy. CRCI is defined as two or more test scores at or below -1.5 standard deviations (SDs), or a single test score at or below -2.0 SDs from baseline to the end of chemotherapy.	After chemotherapy (21 days after the last chemotherapy cycle). Each chemotherapy cycle typically lasts for 4 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog)	FACT-Cog will be used to assess cognitive function and its impact on cancer patients.	During chemotherapy (one day before the third chemotherapy cycle), after chemotherapy (21 days after the last chemotherapy cycle).
Montreal Cognitive Assessment (MoCA)	MoCA will be used to identify the presence of cognitive impairment.	During chemotherapy (one day before the third chemotherapy cycle), after chemotherapy (21 days after the last chemotherapy cycle).
Functional Assessment of Cancer Therapy-General (FACT-G)	FACT-G will be used to measure the impact of cancer and its treatment on patients' overall well-being.	During chemotherapy (one day before the third chemotherapy cycle), after chemotherapy (21 days after the last chemotherapy cycle).
General Anxiety Disorder-7 (GAD-7)	GAD-7 will be used to assess the frequency and severity of symptoms such as excessive worry, restlessness and difficulty in relaxing.	During chemotherapy (one day before the third chemotherapy cycle), after chemotherapy (21 days after the last chemotherapy cycle).
Patient Health Questionnaire-9 (PHQ-9)	PHQ-9 will be used to assess the frequency and severity of several symptoms commonly associated with depression.	During chemotherapy (one day before the third chemotherapy cycle), after chemotherapy (21 days after the last chemotherapy cycle).
Insomnia Severity Index (ISI)	ISI will be used to assess the severity of insomnia symptoms and their impact on an individual's daily functioning	During chemotherapy (one day before the third chemotherapy cycle), after chemotherapy (21 days after the last chemotherapy cycle).
Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)	PRO-CTCAE is a tool used to document self-reported adverse events and their severity on a 5-point scale. In our trial, we plan to evaluate 12 symptoms selected from the original PRO-CTCAE scale, specifically decreased appetite, nausea, vomiting, heartburn, bloating, constipation, diarrhea, abdominal pain, insomnia, fatigue, headache, and dizziness.	During chemotherapy (one day before the third chemotherapy cycle), after chemotherapy (21 days after the last chemotherapy cycle).

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment safety	Incidence of adverse events.	Adverse events will be observed and recorded throughout the trial. The study duration will depend on the chemotherapy cycle of each participant, which may range from 4 months to 8 months.

Collaborators and Investigators

• Sponsor: Beijing University of Chinese Medicine
• Investigators: Principal Investigator: Shiyan Yan, PhD, Beijing University of Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2023
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: June 8, 2023
• First Submitted That Met QC Criteria: July 2, 2023
• First Posted (Actual): July 12, 2023

Study Record Updates

• Last Update Posted (Actual): July 14, 2023
• Last Update Submitted That Met QC Criteria: July 12, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Neurocognitive Disorders; Cognition Disorders; Drug-Related Side Effects and Adverse Reactions; Cognitive Dysfunction; Chemotherapy-Related Cognitive Impairment
• Other Study ID Numbers: YACU003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No