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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
192
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.
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".
Qinghai University Affiliated Hospital
Xining, Qinghai, China
RECRUITINGDifferences in quality of life during the overall stage
Difference in change in EQ-5D-5L scores from first to last assessment between two arms
Time frame: Chemotherapy treatment was initiated to 21 days after the last chemotherapy cycle
Differences in quality of life during the overall stage
Difference in change in FACT-B scores from first to last assessment between two arms
Time frame: Chemotherapy treatment was initiated to 21 days after the last chemotherapy cycle
Changes in scores on the five dimensions of the EQ-5D-5L
Changes in mobility, self-care, daily activities, pain/discomfort,anxiety/depression before and after chemotherapy.
Time frame: Chemotherapy treatment was initiated to 21 days after the last chemotherapy cycle
Changes in the dimensions of the FACT-B scale
Physical functioning, social/family functioning, emotional functioning and functional status before and after chemotherapy
Time frame: Chemotherapy treatment was initiated to 21 days after the last chemotherapy cycle
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