Chemotherapy-Related Cognitive ImpairmentPhase 2NCT05941598
Electroacupuncture for Chemotherapy-Related Cognitive Impairment
A Phase 2 study testing Electroacupuncture in people with Chemotherapy-Related Cognitive Impairment, run by Beijing University of Chinese Medicine.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chemotherapy-Related Cognitive Impairment
- What is being tested?
- Electroacupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2023to 30 Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed with stage I-III breast cancer
- Scheduled to undergo chemotherapy
- Aged between 18 and 75 years
- MoCA score ≥ 26
- Voluntary agreement to participate in the study and sign an informed consent
Who cannot join
- Demonstrated tumor metastasis or recurrence
- Had a prior history of chemotherapy
- Reported a history of brain tumors, head trauma or stroke
- Were diagnosed with cognitive function-impaired disorders, such as Alzheimer's disease
- Were unable to cooperate with testing for any reasons
- Had severe hepatic or renal insufficiency
Show all 10Show fewer
- Had hemorrhagic disorders, including von Willebrand disease, or were taking anticoagulant or antiplatelet medication
- Had an implanted cardiac pacemaker
- Had a history of alcohol abuse or drug addiction
- Were participating in another interventional trial
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Electroacupuncture to Prevent Chemotherapy-Related Cognitive Impairment in Patients With Breast Cancer
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.
Read the 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.
- Being tested
- Electroacupuncture, Sham acupuncture
- Medical subject headings
- Chemotherapy-Related Cognitive Impairment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectroacupunctureDevice
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 acupunctureDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Electroacupuncture | Experimental | 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. Receives: Device: Electroacupuncture |
| Sham acupuncture | Sham comparator | 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. Receives: Device: Sham acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of chemotherapy-related cognitive impairment (CRCI) at the end of chemotherapy
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.
Measured: After chemotherapy (21 days after the last chemotherapy cycle). Each chemotherapy cycle typically lasts for 4 weeks.
Secondary outcomes (7)
Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog)
FACT-Cog will be used to assess cognitive function and its impact on cancer patients.
Measured: During chemotherapy (one day before the third chemotherapy cycle), after chemotherapy (21 days after the last chemotherapy cycle).
Montreal Cognitive Assessment (MoCA)
MoCA will be used to identify the presence of cognitive impairment.
Measured: During chemotherapy (one day before the third chemotherapy cycle), after chemotherapy (21 days after the last chemotherapy cycle).
Functional Assessment of Cancer Therapy-General (FACT-G)
FACT-G will be used to measure the impact of cancer and its treatment on patients' overall well-being.
Measured: During chemotherapy (one day before the third chemotherapy cycle), after chemotherapy (21 days after the last chemotherapy cycle).
General Anxiety Disorder-7 (GAD-7)
GAD-7 will be used to assess the frequency and severity of symptoms such as excessive worry, restlessness and difficulty in relaxing.
Measured: During chemotherapy (one day before the third chemotherapy cycle), after chemotherapy (21 days after the last chemotherapy cycle).
Patient Health Questionnaire-9 (PHQ-9)
PHQ-9 will be used to assess the frequency and severity of several symptoms commonly associated with depression.
Measured: During chemotherapy (one day before the third chemotherapy cycle), after chemotherapy (21 days after the last chemotherapy cycle).
Insomnia Severity Index (ISI)
ISI will be used to assess the severity of insomnia symptoms and their impact on an individual's daily functioning
Measured: During chemotherapy (one day before the third chemotherapy cycle), after chemotherapy (21 days after the last chemotherapy cycle).
Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
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.
Measured: During chemotherapy (one day before the third chemotherapy cycle), after chemotherapy (21 days after the last chemotherapy cycle).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start1 Aug 2023 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-Related Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing University of Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shiyan Yan, Beijing University of Chinese Medicine
- Investigators
- Shiyan Yan, PhD, Principal investigator, Beijing University of Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05941598
- Sponsor's protocol ID
- YACU003
- Status last verified
- Jul 2023
- First submitted
- 8 Jun 2023
- Last updated
- 14 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electroacupuncture to Prevent Chemotherapy-Related Cognitive Impairment in Patients With Breast Cancer
- ClinicalTrials.gov ID
- NCT05941598
- Acronym / sponsor ID
- YACU003
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Beijing University of Chinese MedicineUniversity, hospital or other
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 12 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electroacupuncture | Experimental | Device: ElectroacupunctureAfter 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. |
| Sham acupuncture | Sham comparator | Device: Sham acupunctureAfter 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Newly diagnosed with stage I-III breast cancer
- Scheduled to undergo chemotherapy
- Aged between 18 and 75 years
- MoCA score ≥ 26
- Voluntary agreement to participate in the study and sign an informed consent
Key exclusion criteria (10 listed)
- Demonstrated tumor metastasis or recurrence
- Had a prior history of chemotherapy
- Reported a history of brain tumors, head trauma or stroke
- Were diagnosed with cognitive function-impaired disorders, such as Alzheimer's disease
- Were unable to cooperate with testing for any reasons
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElectroacupunctureParticipants 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. | Device | Electroacupuncture |
| Sham acupunctureParticipants 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. | Device | Sham acupuncture |
Primary outcome
The incidence of chemotherapy-related cognitive impairment (CRCI) at the end of chemotherapy
Time frame: 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.
7 secondary outcomes
Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog)
Time frame: During chemotherapy (one day before the third chemotherapy cycle), after chemotherapy (21 days after the last chemotherapy cycle).
Montreal Cognitive Assessment (MoCA)
Time frame: During chemotherapy (one day before the third chemotherapy cycle), after chemotherapy (21 days after the last chemotherapy cycle).
Functional Assessment of Cancer Therapy-General (FACT-G)
Time frame: During chemotherapy (one day before the third chemotherapy cycle), after chemotherapy (21 days after the last chemotherapy cycle).
General Anxiety Disorder-7 (GAD-7)
Time frame: During chemotherapy (one day before the third chemotherapy cycle), after chemotherapy (21 days after the last chemotherapy cycle).
Patient Health Questionnaire-9 (PHQ-9)
Time frame: During chemotherapy (one day before the third chemotherapy cycle), after chemotherapy (21 days after the last chemotherapy cycle).
Insomnia Severity Index (ISI)
Time frame: During chemotherapy (one day before the third chemotherapy cycle), after chemotherapy (21 days after the last chemotherapy cycle).
Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Time frame: During chemotherapy (one day before the third chemotherapy cycle), after chemotherapy (21 days after the last chemotherapy cycle).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2023.
Related trials for Chemotherapy-Related Cognitive Impairment
Not yet recruiting
Transcranial Direct Current Stimulation for Chemotherapy-Related Chronic Pain in Cancer Survivors
Chronic Pain, Neuropathic Pain
Not yet recruitingObservational study
Cognitive Impairment in Older Adults With Hematologic Malignancies
Cognitive Impairment, Hematologic Malignancies
RecruitingObservational study
Cognitive Impairment in Colorectal Cancer Patients Receiving Cytotoxic Chemotherapy
Neoplasm, Colorectal, Cognitive Impairment
RecruitingObservational study
Cognitive Impact Associated With Surgery For Gastric Or Esophageal Cancer
Gastroesophageal Cancer (GC), Postoperative Delirium (POD)
RecruitingPhase 1/2
Effect of NAC on Preventing Chemo-Related Cognitive Impairments in Ovarian Ca Pts Treated W/ PBT
Ovarian Cancer, Cognitive Impairment
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shiyan Yan, PhD principal investigator
Beijing University of Chinese Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Electroacupuncture in people with Chemotherapy-Related Cognitive Impairment, run by Beijing University of Chinese Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shiyan Yan, PhD (+86-10-64287525, yanshiyan@bucm.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of chemotherapy-related cognitive impairment (CRCI) at the end of chemotherapy (time frame: After chemotherapy (21 days after the last chemotherapy cycle). Each chemotherapy cycle typically lasts for 4 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2023.