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

Not Applicable

Not yet recruiting

• Conditions: Electroacupuncture; Quality of Life (QOL); Acupressure; Breast Cancer; Chemotherapy
• Interventions: Combination Product: electroacupuncture+ self-acupressure; Combination Product: sham electroacupuncture + sham self-acupressure

• Registration Number: NCT06601621
• Lead Sponsor: Jiuda Zhao

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.

Study Timeline

• Status Verified: 2024-09
• Study Start: 2024-09-13
• Study First Submitted: 2024-09-15
• Study First Submitted QC: 2024-09-15
• Last Update Submitted: 2024-09-15
• Study First Posted: 2024-09-19
• Last Update Posted: 2024-09-19
• Primary Completion: 2026-01-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 192

Inclusion Criteria

1. breast cancer patients 18-75 years of age, 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 TCM techniques such as Chinese herbs in the next chemotherapy cycle.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
True electroacupuncture + True self-acupressure	electroacupuncture+ 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.
Sham electroacupuncture + Sham self-acupressure	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".

Primary Outcome Measures

Name	Time	Method
Differences in quality of life during the overall stage	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

Secondary Outcome Measures

Name	Time	Method
Differences in quality of life during the overall stage	Chemotherapy treatment was initiated to 21 days after the last chemotherapy cycle	Difference in change in FACT-B scores from first to last assessment between two arms
Changes in scores on the five dimensions of the EQ-5D-5L	Chemotherapy treatment was initiated to 21 days after the last chemotherapy cycle	Changes in mobility, self-care, daily activities, pain/discomfort,anxiety/depression before and after chemotherapy.
Changes in the dimensions of the FACT-B scale	Chemotherapy treatment was initiated to 21 days after the last chemotherapy cycle	Physical functioning, social/family functioning, emotional functioning and functional status before and after chemotherapy

Trial Locations

Locations (1)

Qinghai University Affiliated Hospital; 🇨🇳 Xining, Qinghai, China