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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Chemotherapy; Electroacupuncture; Acupressure; Quality of Life (QOL)
• Intervention / Treatment: Combination product: electroacupuncture+ self-acupressure; Combination product: sham electroacupuncture + sham self-acupressure

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 Type: Interventional
• Enrollment (Estimated): 192
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Qinghai
    • Xining, Qinghai, China, 810000
      • Recruiting
      • Qinghai University Affiliated Hospital
      • Contact: Jiuda Zhao, Dr; Phone Number: 869716230893; Email: jiudazhao@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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.
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; 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".

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Chemotherapy treatment was initiated to 21 days after the last chemotherapy cycle

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences in quality of life during the overall stage	Difference in change in FACT-B scores from first to last assessment between two arms	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.	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	Chemotherapy treatment was initiated to 21 days after the last chemotherapy cycle

Collaborators and Investigators

• Sponsor: Jiuda Zhao

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2024
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): April 30, 2026

Study Registration Dates

• First Submitted: September 15, 2024
• First Submitted That Met QC Criteria: September 15, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): February 12, 2026
• Last Update Submitted That Met QC Criteria: February 11, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: breast cancer; electroacupuncture; Quality of life (QOL); self-acupressure
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: AHQU-2024002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No