Electroacupuncture for Chemotherapy-Related Cognitive Impairment

Beijing University of Chinese Medicine

Status and phase: Not yet enrolling; Phase 2

Conditions: Chemotherapy-Related Cognitive Impairment

Treatments: Device: Sham acupuncture; Device: Electroacupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT05941598

YACU003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Electroacupuncture

Experimental group

Description:

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.

Treatment:

Device: Electroacupuncture

Sham acupuncture

Sham Comparator group

Description:

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.

Treatment:

Device: Sham acupuncture