Electroacupuncture plus self-acupressure to improve quality of life during chemotherapy for early-stage breast cancer
Study on the Impact of Electroacupuncture Combined With Self-Acupressure on the Quality of Life of Patients With Early-Stage Breast Cancer Undergoing Chemotherapy
This trial tests whether adding electroacupuncture together with self-acupressure can improve quality of life for people with early-stage breast cancer who are receiving chemotherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 192 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Affiliated Hospital of Qinghai University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Xining, Qinghai) |
| Trial ID | NCT06601621 on ClinicalTrials.gov |
What this trial studies
This is a randomized, parallel-group, blinded trial comparing electroacupuncture plus self-acupressure versus sham electroacupuncture plus sham acupressure in patients with early-stage breast cancer undergoing chemotherapy. Electroacupuncture (or sham) is delivered during the first week of each chemotherapy cycle, and participants perform self-acupressure (or sham) during the second and third weeks. Participants and outcome assessors are blinded, and randomization allocates patients to active or sham groups. Quality of life is measured with the EQ-5D-5L and FACT-B instruments as primary outcomes, with additional secondary endpoints recorded.
Who should consider this trial
Good fit: Adults aged 18–75 with early-stage breast cancer, ECOG performance status 0–2, chemotherapy-naive and scheduled for at least four cycles, with adequate organ function and the ability to complete study questionnaires are appropriate candidates.
Not a fit: Patients with needle phobia or stainless steel needle allergy, current severe mental illness, or those unable to perform self-acupressure or adhere to clinic visits are unlikely to receive benefit from this intervention.
Why it matters
Potential benefit: If successful, the combination could improve patients' quality of life and reduce chemotherapy-related symptoms during treatment.
How similar studies have performed: Previous acupuncture studies in cancer care have shown mixed but sometimes positive effects on symptoms and quality of life, while the specific combination of electroacupuncture plus self-acupressure is relatively untested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Xining, Qinghai
- Qinghai University Affiliated Hospital — Xining, Qinghai, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.