Electroacupuncture for Chemotherapy-Related Cognitive Impairment

NCT ID: NCT05941598

Last Updated: 2023-07-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2024-12-30

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.

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.

Conditions

Chemotherapy-Related Cognitive Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Electroacupuncture

Intervention Type: 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.

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.

Group Type: SHAM_COMPARATOR

Sham acupuncture

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing University of Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Shiyan Yan

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shiyan Yan, PhD

Role: PRINCIPAL_INVESTIGATOR

Beijing University of Chinese Medicine

Central Contacts

Shiyan Yan, PhD

Role: CONTACT

yanshiyan@bucm.edu.cn

+86-10-64287525

Zhiyi Xiong, MM

Role: CONTACT

zhiyixiong@foxmail.com

+86 18811022104

Other Identifiers

YACU003

Identifier Type: -

Identifier Source: org_study_id