Electroacupuncture for Chemotherapy-Related Cognitive Impairment

NCT05941598 | Unknown Phase 2

• 1 other identifier: YACU003
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Chemotherapy-Related Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog)

  During chemotherapy (one day before the third chemotherapy cycle), after chemotherapy (21 days after the last chemotherapy cycle).

• Montreal Cognitive Assessment (MoCA)

  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)

  During chemotherapy (one day before the third chemotherapy cycle), after chemotherapy (21 days after the last chemotherapy cycle).

• General Anxiety Disorder-7 (GAD-7)

  During chemotherapy (one day before the third chemotherapy cycle), after chemotherapy (21 days after the last chemotherapy cycle).

• Patient Health Questionnaire-9 (PHQ-9)

  During chemotherapy (one day before the third chemotherapy cycle), after chemotherapy (21 days after the last chemotherapy cycle).

Other Outcomes (1)

• Treatment safety

  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.

Study Arms (2)

Electroacupuncture

EXPERIMENTAL

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

Sham acupuncture

SHAM COMPARATOR

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

Interventions

Electroacupuncture DEVICE

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.

Electroacupuncture

Sham acupuncture DEVICE

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.

Sham acupuncture

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Beijing University of Chinese Medicine: lead

MeSH Terms

Conditions

Chemotherapy-Related Cognitive Impairment

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Officials

• Shiyan Yan, PhD

  Beijing University of Chinese Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shiyan Yan, PhD

CONTACT

+86-10-64287525; yanshiyan@bucm.edu.cn

Zhiyi Xiong, MM

CONTACT

+86 18811022104; zhiyixiong@foxmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 8, 2023
• First Posted: July 12, 2023
• Study Start: August 1, 2023
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: July 14, 2023

Record last verified: 2023-07