ElectroacupunctureNCT06601621
Study on the Impact of Electroacupuncture Combined With Self-Acupressure on the Quality of Life of Patients With Early-Stage Breast Cancer Undergoing Chemotherapy
A study testing electroacupuncture+ self-acupressure in people with Electroacupuncture and Quality of Life (QOL), run by Jiuda Zhao at 1 site in China.
Trial summary
This randomized controlled clinical trial aims to evaluate the effect of electroacupuncture combined with self-acupressure on the quality of life of early-stage breast cancer patients receiving chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Electroacupuncture, Quality of Life (QOL), Acupressure
- What is being tested?
- electroacupuncture+ self-acupressure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 192 participants
- Where
- 1 siteChina
- Study dates
- 19 Oct 2024to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Aged 18 years or older and aged 75 years or younger, inclusive. with an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
- Patients who have not received prior chemotherapy and are scheduled to receive at least 4 cycles of adjuvant or neoadjuvant chemotherapy or combination targeted therapy;
- Normal organ function with platelets ≥ 100*10^9/ L, hemoglobin ≥ 90 g/L, serum creatinine ≤ 1.5 mg/dl (133 mmol/L), or creatinine clearance ≥ 60 ml/min, total bilirubin ≤ 1.5 times the upper limit of normal (ULN), alanine aminotransferase ≤ 2.5 times ULN, and aspartate aminotransferase ≤ 2.5 times ULN;
- Premenopausal women need appropriate contraception;
- Ability to understand the study well and complete the study questionnaire.
Who cannot join
- Patients with needle phobia or allergy to stainless steel needles; and
- Current diagnosis of mental illness (e.g., major depression, obsessive-compulsive disorder, or schizophrenia);
- History of autoimmune diseases, blood disorders, or organ transplantation, or long-term use of hormones or immunosuppressants;
- Comorbid bleeding disorders or thyroid dysfunction;
- Implantation of a pacemaker; pregnancy or breastfeeding;
- A plan for adjuvant radiotherapy in the upcoming chemotherapy cycle;
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- Current active infection;
- Acupuncture treatment within the last four weeks;
- Patients who are allergic to the drugs used;
- Use of other Traditional Chinese Medicine (TCM) techniques such as Chinese herbs in the next chemotherapy cycle.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Qinghai University Affiliated Hospital
Xining, Qinghai, 810000
Jiuda Zhao, Dr, 869716230893, jiudazhao@126.com
About this study
This randomized controlled clinical trial aims to evaluate the effect of electroacupuncture combined with self-acupressure on the quality of life of early-stage breast cancer patients receiving chemotherapy.
Read the detailed description
This study is a parallel-group, blinded (participant, evaluator, and statisticians), randomized controlled trial to investigate the effect of electroacupuncture combined with self-acupressure on the quality of life of early-stage breast cancer patients receiving chemotherapy. Patients in each group will receive electroacupuncture or sham electroacupuncture during the first week of the chemotherapy cycle. They will receive self-acupressure or sham acupressure during the second and third weeks of the chemotherapy cycle. Participants will be asked to complete the EQ-5D-5L and FACT-B scales. Primary and secondary outcomes will be assessed.
- Being tested
- electroacupuncture+ self-acupressure, sham electroacupuncture + sham self-acupressure
- Keywords
- electroacupuncture, self-acupressure, Quality of life (QOL), breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electroacupuncture+ self-acupressureCombination product
Participants will receive two electroacupuncture treatments within the first week of each treatment cycle. The acupuncturist inserts the needle into the point and manipulates the needle until the feeling of "deqi"; is achieved and reported by the participant. The electrical stimulation will be administered at a sustained frequency of 2/10Hz for 30 minutes. self-acupressure: In weeks 2 and 3 of each treatment cycle, participants performed true self-administered acupressure, pressing each acupoint with their thumb to achieve "deqi"; for three minutes.
sham electroacupuncture + sham self-acupressureCombination product
Sham electroacupuncture: The sham electroacupuncture shallow needle insertion using thin and short needles at body locations not recognized as true acupuncture points and are deemed to not belong to traditional Chinese meridians and have no therapeutic value. Participants will receive acupuncture treatment without electrical stimulation same the intervention group. And avoid "deqi"; sensation. Sham self-acupressure: Administered non-acupressure points 1 to 3cm away from the true acupressure points used in the experimental group and away from known meridians. The frequency, course duration, and overall treatment time will be the same as those in the true self-administered shiatsu group. The applied pressure does not cause a feeling of "deqi".
| Study group | Role | What they receive |
|---|---|---|
| True electroacupuncture + True self-acupressure | Experimental | Participants will receive two electroacupuncture treatments during the first week of the chemotherapy cycle. The acupuncturist will insert needles into the acupoints and manipulate the needles until"de qi"sensation is achieved and reported by the participants. Electrical stimulation will be delivered for 30 minutes at alternating frequencies of 2/10Hz. Participants will do acupressure daily during the second week of the chemotherapy cycle (two weeks for one chemotherapy cycle) or the second and third weeks (three weeks for one chemotherapy cycle). participants performed true self-acupressure, pressing each acupoint with their thumb to achieve "deqi" for three minutes. Receives: Combination Product: electroacupuncture+ self-acupressure |
| Sham electroacupuncture + Sham self-acupressure | Placebo comparator | The sham acupuncture is the use of minimally invasive shallow needle insertion using thin and short needles at body locations not recognized as true acupuncture points and are deemed to not belong to traditional Chinese meridians and have no therapeutic value. Participants will receive minimal acupuncture treatment without electrical stimulation at the same time as the intervention group. Care was taken to avoid "de qi" sensation. Sham self-acupressure: Administered non-acupressure points 1 to 3cm away from the true acupressure points used in the experimental group and away from known meridians. The frequency, course duration, and overall treatment time will be the same as those in the true self-administered shiatsu group. The applied pressure does not cause a feeling of "deqi". Receives: Combination Product: sham electroacupuncture + sham self-acupressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in quality of life during the overall stage
Difference in change in EQ-5D-5L scores from first to last assessment between two arms
Measured: Chemotherapy treatment was initiated to 21 days after the last chemotherapy cycle
Secondary outcomes (3)
Differences in quality of life during the overall stage
Difference in change in FACT-B scores from first to last assessment between two arms
Measured: Chemotherapy treatment was initiated to 21 days after the last chemotherapy cycle
Changes in scores on the five dimensions of the EQ-5D-5L
Changes in mobility, self-care, daily activities, pain/discomfort,anxiety/depression before and after chemotherapy.
Measured: Chemotherapy treatment was initiated to 21 days after the last chemotherapy cycle
Changes in the dimensions of the FACT-B scale
Physical functioning, social/family functioning, emotional functioning and functional status before and after chemotherapy
Measured: Chemotherapy treatment was initiated to 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 posted19 Sep 2024
- Study start19 Oct 2024
- Primary completion31 Mar 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElectroacupunctureStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiuda Zhao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jiuda Zhao, Affiliated Hospital of Qinghai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06601621
- Sponsor's protocol ID
- AHQU-2024002
- Status last verified
- Feb 2026
- First submitted
- 15 Sep 2024
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Impact of Electroacupuncture Combined With Self-Acupressure on the Quality of Life of Patients With Early-Stage Breast Cancer Undergoing Chemotherapy
- ClinicalTrials.gov ID
- NCT06601621
- Acronym / sponsor ID
- AHQU-2024002
- Keywords
- electroacupuncture, self-acupressure, Quality of life (QOL), breast cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- Jiuda ZhaoUniversity, hospital or other
- Study start
- 19 Oct 2024 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 19 Sep 2024 (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.
This randomized controlled clinical trial aims to evaluate the effect of electroacupuncture combined with self-acupressure on the quality of life of early-stage breast cancer patients receiving chemotherapy.
Detailed description
This study is a parallel-group, blinded (participant, evaluator, and statisticians), randomized controlled trial to investigate the effect of electroacupuncture combined with self-acupressure on the quality of life of early-stage breast cancer patients receiving chemotherapy. Patients in each group will receive electroacupuncture or sham electroacupuncture during the first week of the chemotherapy cycle. They will receive self-acupressure or sham acupressure during the second and third weeks of the chemotherapy cycle. Participants will be asked to complete the EQ-5D-5L and FACT-B scales. Primary and secondary outcomes will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| True electroacupuncture + True self-acupressure | Experimental | Combination Product: electroacupuncture+ self-acupressureParticipants will receive two electroacupuncture treatments during the first week of the chemotherapy cycle. The acupuncturist will insert needles into the acupoints and manipulate the needles until"de qi"sensation is achieved and reported by the participants. Electrical stimulation will be delivered for 30 minutes at alternating frequencies of 2/10Hz. Participants will do acupressure daily during the second week of the chemotherapy cycle (two weeks for one chemotherapy cycle) or the second and third weeks (three weeks for one chemotherapy cycle). participants performed true self-acupressure, pressing each acupoint with their thumb to achieve "deqi" for three minutes. |
| Sham electroacupuncture + Sham self-acupressure | Placebo comparator | Combination Product: sham electroacupuncture + sham self-acupressureThe sham acupuncture is the use of minimally invasive shallow needle insertion using thin and short needles at body locations not recognized as true acupuncture points and are deemed to not belong to traditional Chinese meridians and have no therapeutic value. Participants will receive minimal acupuncture treatment without electrical stimulation at the same time as the intervention group. Care was taken to avoid "de qi" sensation. Sham self-acupressure: Administered non-acupressure points 1 to 3cm away from the true acupressure points used in the experimental group and away from known meridians. The frequency, course duration, and overall treatment time will be the same as those in the true self-administered shiatsu group. The applied pressure does not cause a feeling of "deqi". |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18 years or older and aged 75 years or younger, inclusive. with an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
- Patients who have not received prior chemotherapy and are scheduled to receive at least 4 cycles of adjuvant or neoadjuvant chemotherapy or combination targeted therapy;
- Normal organ function with platelets ≥ 100*10^9/ L, hemoglobin ≥ 90 g/L, serum creatinine ≤ 1.5 mg/dl (133 mmol/L), or creatinine clearance ≥ 60 ml/min, total bilirubin ≤ 1.5 times the upper limit of normal (ULN), alanine aminotransferase ≤ 2.5 times ULN, and aspartate aminotransferase ≤ 2.5 times ULN;
- Premenopausal women need appropriate contraception;
- Ability to understand the study well and complete the study questionnaire.
Key exclusion criteria (10 listed)
- Patients with needle phobia or allergy to stainless steel needles; and
- Current diagnosis of mental illness (e.g., major depression, obsessive-compulsive disorder, or schizophrenia);
- History of autoimmune diseases, blood disorders, or organ transplantation, or long-term use of hormones or immunosuppressants;
- Comorbid bleeding disorders or thyroid dysfunction;
- Implantation of a pacemaker; pregnancy or breastfeeding;
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 |
|---|---|---|
| electroacupuncture+ self-acupressureParticipants will receive two electroacupuncture treatments within the first week of each treatment cycle. The acupuncturist inserts the needle into the point and manipulates the needle until the feeling of "deqi"; is achieved and reported by the participant. The electrical stimulation will be administered at a sustained frequency of 2/10Hz for 30 minutes. self-acupressure: In weeks 2 and 3 of each treatment cycle, participants performed true self-administered acupressure, pressing each acupoint with their thumb to achieve "deqi"; for three minutes. | Combination product | True electroacupuncture + True self-acupressure |
| sham electroacupuncture + sham self-acupressureSham electroacupuncture: The sham electroacupuncture shallow needle insertion using thin and short needles at body locations not recognized as true acupuncture points and are deemed to not belong to traditional Chinese meridians and have no therapeutic value. Participants will receive acupuncture treatment without electrical stimulation same the intervention group. And avoid "deqi"; sensation. Sham self-acupressure: Administered non-acupressure points 1 to 3cm away from the true acupressure points used in the experimental group and away from known meridians. The frequency, course duration, and overall treatment time will be the same as those in the true self-administered shiatsu group. The applied pressure does not cause a feeling of "deqi". | Combination product | Sham electroacupuncture + Sham self-acupressure |
Primary outcome
Differences in quality of life during the overall stage
Time frame: Chemotherapy treatment was initiated to 21 days after the last chemotherapy cycle
Difference in change in EQ-5D-5L scores from first to last assessment between two arms
3 secondary outcomes
Differences in quality of life during the overall stage
Time frame: Chemotherapy treatment was initiated to 21 days after the last chemotherapy cycle
Changes in scores on the five dimensions of the EQ-5D-5L
Time frame: Chemotherapy treatment was initiated to 21 days after the last chemotherapy cycle
Changes in the dimensions of the FACT-B scale
Time frame: Chemotherapy treatment was initiated to 21 days after the last chemotherapy cycle
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electroacupuncture+ self-acupressure in people with Electroacupuncture and Quality of Life (QOL), run by Jiuda Zhao at 1 site in China.
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: looking for participants now, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in quality of life during the overall stage (time frame: Chemotherapy treatment was initiated to 21 days after the last chemotherapy cycle). 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 12 Feb 2026.