Clinical trial NCT05941598: Electroacupuncture for Chemotherapy-Related Cognitive Impairment
Official title: Electroacupuncture to Prevent Chemotherapy-Related Cognitive Impairment in Patients With Breast Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Chemotherapy-Related Cognitive Impairment
Lead sponsor: Beijing University of Chinese Medicine
Sponsor class: OTHER
First posted: 2023-07-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: The incidence of chemotherapy-related cognitive impairment (CRCI) at the end of chemotherapy
timeFrame: After chemotherapy (21 days after the last chemotherapy cycle). Each chemotherapy cycle typically lasts for 4 weeks.
Secondary outcomes:
measure: Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog)
timeFrame: During chemotherapy (one day before the third chemotherapy cycle), after chemotherapy (21 days after the last chemotherapy cycle).
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: During chemotherapy (one day before the third chemotherapy cycle), after chemotherapy (21 days after the last chemotherapy cycle).
measure: Functional Assessment of Cancer Therapy-General (FACT-G)
timeFrame: During chemotherapy (one day before the third chemotherapy cycle), after chemotherapy (21 days after the last chemotherapy cycle).
measure: General Anxiety Disorder-7 (GAD-7)
timeFrame: During chemotherapy (one day before the third chemotherapy cycle), after chemotherapy (21 days after the last chemotherapy cycle).
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: During chemotherapy (one day before the third chemotherapy cycle), after chemotherapy (21 days after the last chemotherapy cycle).
measure: Insomnia Severity Index (ISI)
timeFrame: During chemotherapy (one day before the third chemotherapy cycle), after chemotherapy (21 days after the last chemotherapy cycle).
measure: Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
timeFrame: During chemotherapy (one day before the third chemotherapy cycle), after chemotherapy (21 days after the last chemotherapy cycle).
Other outcomes:
measure: Treatment safety
timeFrame: 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.
Locations:
Study officials:
affiliation: Beijing University of Chinese Medicine
name: Shiyan Yan, PhD
role: PRINCIPAL_INVESTIGATOR
References: