Clinical trial NCT06601621: Study on the Impact of Electroacupuncture Combined with Self-Acupressure on the Quality of Life of Patients with Early-Stage Breast Cancer Undergoing Chemotherapy
Official title: Study on the Impact of Electroacupuncture Combined with Self-Acupressure on the Quality of Life of Patients with Early-Stage Breast Cancer Undergoing Chemotherapy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Electroacupuncture
Quality of Life (QOL)
Acupressure
Breast Cancer
Chemotherapy
Keywords: electroacupuncture
self-acupressure
Quality of life (QOL)
breast cancer
Lead sponsor: Affiliated Hospital of Qinghai University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Differences in quality of life during the overall stage
timeFrame: Chemotherapy treatment was initiated to 21 days after the last chemotherapy cycle
Secondary outcomes:
measure: Differences in quality of life during the overall stage
timeFrame: Chemotherapy treatment was initiated to 21 days after the last chemotherapy cycle
measure: Changes in scores on the five dimensions of the EQ-5D-5L
timeFrame: Chemotherapy treatment was initiated to 21 days after the last chemotherapy cycle
measure: Changes in the dimensions of the FACT-B scale
timeFrame: Chemotherapy treatment was initiated to 21 days after the last chemotherapy cycle
Other outcomes:
Locations:
city: Xining
country: China
facility: Qinghai University Affiliated Hospital
state: Qinghai
Study officials:
References: