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.
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;
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;
Parallel
electroacupuncture+ self-acupressure
Combination productParticipants 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
Combination productSham 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".
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
Differences in quality of life during the overall stage
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
Changes in mobility, self-care, daily activities, pain/discomfort,anxiety/depression before and after chemotherapy.
Changes in the dimensions of the FACT-B scale
Physical functioning, social/family functioning, emotional functioning and functional status before and after chemotherapy
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Jiuda Zhao
Lead sponsor
Affiliated Hospital of Qinghai University
Sponsor institution
