RecruitingNot ApplicableNCT06601621

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

Sponsor

Jiuda Zhao

Enrollment

192 participants

Start Date

Oct 19, 2024

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Quality of Life (QOL)Chemotherapy Electroacupuncture Acupressure

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria5

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.

Exclusion Criteria10

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;
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.

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".