Overview
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.
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.
Eligibility
Inclusion Criteria:
- 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 Criteria:
- 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.
