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RecruitingNCT06601621Updated Feb 12, 2026

Study on the Impact of Electroacupuncture Combined With Self-Acupressure on the Quality of Life of Patients With Early-Stage Breast Cancer Undergoing Chemotherapy

An interventional study of electroacupuncture+ self-acupressure and sham electroacupuncture + sham self-acupressure in Electroacupuncture, Quality of Life (QOL) and Acupressure, sponsored by Jiuda Zhao. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-02-12.

Sponsored by Jiuda Zhao · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
192
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Electroacupuncture
  • Quality of Life (QOL)
  • Acupressure
  • Breast Cancer
  • Chemotherapy

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Keywords

  • electroacupuncture
  • self-acupressure
  • Quality of life (QOL)
  • breast cancer
03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Aged 18 years or older and aged 75 years or younger, inclusive. with an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
  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;
  3. 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;
  4. Premenopausal women need appropriate contraception;
  5. Ability to understand the study well and complete the study questionnaire.

Exclusion criteria

Exclusion Criteria:

  1. Patients with needle phobia or allergy to stainless steel needles; and
  2. Current diagnosis of mental illness (e.g., major depression, obsessive-compulsive disorder, or schizophrenia);
  3. History of autoimmune diseases, blood disorders, or organ transplantation, or long-term use of hormones or immunosuppressants;
  4. Comorbid bleeding disorders or thyroid dysfunction;
  5. Implantation of a pacemaker; pregnancy or breastfeeding;
  6. A plan for adjuvant radiotherapy in the upcoming chemotherapy cycle;
  7. Current active infection;
  8. Acupuncture treatment within the last four weeks;
  9. Patients who are allergic to the drugs used;
  10. Use of other Traditional Chinese Medicine (TCM) techniques such as Chinese herbs in the next chemotherapy cycle.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
192 participants (estimated)

Study arms

  • Experimental
    True electroacupuncture + True self-acupressure

    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.

    Combination Product: electroacupuncture+ self-acupressure

  • Placebo comparator
    Sham electroacupuncture + Sham self-acupressure

    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".

    Combination Product: sham electroacupuncture + sham self-acupressure

Interventions

  • Combination productelectroacupuncture+ self-acupressure

    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.

  • Combination productsham electroacupuncture + sham self-acupressure

    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".

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: Chemotherapy treatment was initiated to 21 days after the last chemotherapy cycle

Secondary outcomes

  1. Differences in quality of life during the overall stage

    Difference in change in FACT-B scores from first to last assessment between two arms

    Time frame: Chemotherapy treatment was initiated to 21 days after the last chemotherapy cycle

  2. 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.

    Time frame: Chemotherapy treatment was initiated to 21 days after the last chemotherapy cycle

  3. Changes in the dimensions of the FACT-B scale

    Physical functioning, social/family functioning, emotional functioning and functional status before and after chemotherapy

    Time frame: Chemotherapy treatment was initiated to 21 days after the last chemotherapy cycle

06

Study locations

1 of 1 sites recruiting
  • Qinghai University Affiliated Hospital
    Xining, Qinghai 810000, China
    Recruiting
07

Registry details

Key details

Study ID
NCT06601621
Lead sponsor
Jiuda Zhao
Responsible party
Jiuda Zhao (Breast Disease Diagnosis and Treatment Center, Affiliated Hospital of Qinghai University) — Sponsor-investigator
First posted
Sep 19, 2024
Start date
Oct 19, 2024
Primary completion
Mar 31, 2026 (estimated)
Completion
Apr 30, 2026 (estimated)
Last update
Feb 12, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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