Status:
NOT_YET_RECRUITING
Study on the Impact of Electroacupuncture Combined with Self-Acupressure on the Quality of Life of Patients with Early-Stage Breast Cancer Undergoing Chemotherapy
Lead Sponsor:
Jiuda Zhao
Conditions:
Electroacupuncture
Quality of Life (QOL)
Eligibility:
All Genders
18-75 years
Phase:
NA
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 chemot...
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 q...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2026
Estimated Enrollment :
192 Patients enrolled
Trial Details
Trial ID
NCT06601621
Start Date
September 19 2024
End Date
March 31 2026
Last Update
September 27 2024
Active Locations (1)
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1
Qinghai University Affiliated Hospital
Xining, Qinghai, China, 810000