Chemotherapy-Related Cognitive Impairment
Conditions
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.
Interventions
DEVICEElectroacupuncture
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.
DEVICESham 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.
Sponsors
Beijing University of Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of chemotherapy-related cognitive impairment (CRCI) at the end of chemotherapy | After chemotherapy (21 days after the last chemotherapy cycle). Each chemotherapy cycle typically lasts for 4 weeks. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). | FACT-Cog will be used to assess cognitive function and its impact on cancer patients. |
| Montreal Cognitive Assessment (MoCA) | During chemotherapy (one day before the third chemotherapy cycle), after chemotherapy (21 days after the last chemotherapy cycle). | MoCA will be used to identify the presence of cognitive impairment. |
| 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). | FACT-G will be used to measure the impact of cancer and its treatment on patients' overall well-being. |
| Patient Health Questionnaire-9 (PHQ-9) | During chemotherapy (one day before the third chemotherapy cycle), after chemotherapy (21 days after the last chemotherapy cycle). | PHQ-9 will be used to assess the frequency and severity of several symptoms commonly associated with depression. |
| Insomnia Severity Index (ISI) | During chemotherapy (one day before the third chemotherapy cycle), after chemotherapy (21 days after the last chemotherapy cycle). | ISI will be used to assess the severity of insomnia symptoms and their impact on an individual's daily functioning |
| Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | During chemotherapy (one day before the third chemotherapy cycle), after chemotherapy (21 days after the last chemotherapy cycle). | PRO-CTCAE is a tool used to document self-reported adverse events and their severity on a 5-point scale. In our trial, we plan to evaluate 12 symptoms selected from the original PRO-CTCAE scale, specifically decreased appetite, nausea, vomiting, heartburn, bloating, constipation, diarrhea, abdominal pain, insomnia, fatigue, headache, and dizziness. |
| General Anxiety Disorder-7 (GAD-7) | During chemotherapy (one day before the third chemotherapy cycle), after chemotherapy (21 days after the last chemotherapy cycle). | GAD-7 will be used to assess the frequency and severity of symptoms such as excessive worry, restlessness and difficulty in relaxing. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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. | Incidence of adverse events. |
Contacts
Primary ContactShiyan Yan, PhD
Backup ContactZhiyi Xiong, MM
Outcome results
None listed