Acupressure, Breast Cancer, Chemotherapy, Electroacupuncture, Quality of Life (QOL)
Conditions
Keywords
electroacupuncture, self-acupressure, Quality of life (QOL), breast cancer
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.
Interventions
COMBINATION_PRODUCTelectroacupuncture+ self-acupressure
Participants 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.
COMBINATION_PRODUCTsham electroacupuncture + sham self-acupressure
Sham 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".
Sponsors
Jiuda Zhao
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Differences in quality of life during the overall stage | Chemotherapy treatment was initiated to 21 days after the last chemotherapy cycle | Difference in change in EQ-5D-5L scores from first to last assessment between two arms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Differences in quality of life during the overall stage | Chemotherapy treatment was initiated to 21 days after the last chemotherapy cycle | 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 | Chemotherapy treatment was initiated to 21 days after the last chemotherapy cycle | Changes in mobility, self-care, daily activities, pain/discomfort,anxiety/depression before and after chemotherapy. |
| Changes in the dimensions of the FACT-B scale | Chemotherapy treatment was initiated to 21 days after the last chemotherapy cycle | Physical functioning, social/family functioning, emotional functioning and functional status before and after chemotherapy |
Countries
China
Outcome results
None listed