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

NCT ID: NCT06601621

Last Updated: 2026-02-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 192 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-19
• Study Completion Date: 2026-04-30

Brief 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.

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

electroacupuncture+ self-acupressure

Intervention Type: COMBINATION_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-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".

Group Type: PLACEBO_COMPARATOR

sham electroacupuncture + sham self-acupressure

Intervention Type: COMBINATION_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".

Interventions

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.

Intervention Type: 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".

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiuda Zhao

OTHER

Sponsor Role: lead

Responsible Party

Jiuda Zhao

Breast Disease Diagnosis and Treatment Center

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Qinghai University Affiliated Hospital

Xining, Qinghai, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Jiuda Zhao, Dr

Role: primary

jiudazhao@126.com

869716230893

Other Identifiers

AHQU-2024002

Identifier Type: -

Identifier Source: org_study_id