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Trial Title:
Electroacupuncture for Chemotherapy-Related Cognitive Impairment
NCT ID:
NCT05941598
Condition:
Chemotherapy-Related Cognitive Impairment
Conditions: Official terms:
Chemotherapy-Related Cognitive Impairment
Cognitive Dysfunction
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
Double (Participant, Outcomes Assessor)
Intervention:
Intervention type:
Device
Intervention name:
Electroacupuncture
Description:
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.
Arm group label:
Electroacupuncture
Intervention type:
Device
Intervention name:
Sham acupuncture
Description:
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.
Arm group label:
Sham acupuncture
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
August 1, 2023
Completion date:
December 30, 2024
Lead sponsor:
Agency:
Beijing University of Chinese Medicine
Agency class:
Other
Source:
Beijing University of Chinese Medicine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05941598
