Electroacupuncture for Chemotherapy-Related Cognitive Impairment

Chemotherapy-Related Cognitive Impairment Clinical Trial

Official title:

Electroacupuncture to Prevent Chemotherapy-Related Cognitive Impairment in Patients With Breast Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05941598
• Other study ID #: YACU003
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: August 1, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: July 2023
• Source: Beijing University of Chinese Medicine
• Contact: Shiyan Yan, PhD
• Phone: +86-10-64287525
• Email: yanshiyan[@]bucm.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Chemotherapy-Related Cognitive Impairment
• Cognitive Dysfunction

Intervention

Device:
• Electroacupuncture
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 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beijing University of Chinese Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Treatment safety	Incidence of adverse events.	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.
Primary	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.	After chemotherapy (21 days after the last chemotherapy cycle). Each chemotherapy cycle typically lasts for 4 weeks.
Secondary	Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog)	FACT-Cog will be used to assess cognitive function and its impact on cancer patients.	During chemotherapy (one day before the third chemotherapy cycle), after chemotherapy (21 days after the last chemotherapy cycle).
Secondary	Montreal Cognitive Assessment (MoCA)	MoCA will be used to identify the presence of cognitive impairment.	During chemotherapy (one day before the third chemotherapy cycle), after chemotherapy (21 days after the last chemotherapy cycle).
Secondary	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.	During chemotherapy (one day before the third chemotherapy cycle), after chemotherapy (21 days after the last chemotherapy cycle).
Secondary	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.	During chemotherapy (one day before the third chemotherapy cycle), after chemotherapy (21 days after the last chemotherapy cycle).
Secondary	Patient Health Questionnaire-9 (PHQ-9)	PHQ-9 will be used to assess the frequency and severity of several symptoms commonly associated with depression.	During chemotherapy (one day before the third chemotherapy cycle), after chemotherapy (21 days after the last chemotherapy cycle).
Secondary	Insomnia Severity Index (ISI)	ISI will be used to assess the severity of insomnia symptoms and their impact on an individual's daily functioning	During chemotherapy (one day before the third chemotherapy cycle), after chemotherapy (21 days after the last chemotherapy cycle).
Secondary	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.	During chemotherapy (one day before the third chemotherapy cycle), after chemotherapy (21 days after the last chemotherapy cycle).