Electroacupuncture for Chemotherapy-Related Cognitive Impairment

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Primary Purpose

Status

Not yet recruiting

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Electroacupuncture

Sham acupuncture

About this trial

This is an interventional prevention trial for Chemotherapy-Related Cognitive Impairment

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Electroacupuncture

Sham acupuncture

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog)

FACT-Cog will be used to assess cognitive function and its impact on cancer patients.

Montreal Cognitive Assessment (MoCA)

MoCA will be used to identify the presence of cognitive impairment.

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.

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.

Patient Health Questionnaire-9 (PHQ-9)

PHQ-9 will be used to assess the frequency and severity of several symptoms commonly associated with depression.

Insomnia Severity Index (ISI)

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)

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.

Full Information

NCT ID

NCT05941598

First Posted

June 8, 2023

Last Updated

July 12, 2023

Sponsor

Beijing University of Chinese Medicine

1. Study Identification

Unique Protocol Identification Number

NCT05941598

Brief Title

Electroacupuncture for Chemotherapy-Related Cognitive Impairment

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

August 1, 2023 (Anticipated)

Primary Completion Date

December 30, 2024 (Anticipated)

Study Completion Date

December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Beijing University of Chinese Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chemotherapy-Related Cognitive Impairment

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Electroacupuncture

Arm Type

Experimental

Arm Description

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.

Arm Title

Sham acupuncture

Arm Type

Sham Comparator

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

Electroacupuncture

Intervention 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.

Intervention Type

Device

Intervention Name(s)

Sham acupuncture

Intervention 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.

Primary Outcome Measure Information:

Title

The incidence of chemotherapy-related cognitive impairment (CRCI) at the end of chemotherapy

Description

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.

Time Frame

After chemotherapy (21 days after the last chemotherapy cycle). Each chemotherapy cycle typically lasts for 4 weeks.

Secondary Outcome Measure Information:

Title

Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog)

Description

FACT-Cog will be used to assess cognitive function and its impact on cancer patients.

Time Frame