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Trial 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
NCT ID:
NCT06601621
Condition:
Electroacupuncture
Quality of Life (QOL)
Acupressure
Breast Cancer
Chemotherapy
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
electroacupuncture
self-acupressure
Quality of life (QOL)
breast cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Combination Product
Intervention name:
electroacupuncture+ self-acupressure
Description:
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.
Arm group label:
True electroacupuncture + True self-acupressure
Intervention type:
Combination Product
Intervention name:
sham electroacupuncture + sham self-acupressure
Description:
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".
Arm group label:
Sham electroacupuncture + Sham self-acupressure
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Qinghai University Affiliated Hospital
Address:
City:
Xining
Zip:
810000
Country:
China
Contact:
Last name:
Jiuda Zhao, Dr
Phone:
869716230893
Email:
jiudazhao@126.com
Start date:
September 19, 2024
Completion date:
March 31, 2026
Lead sponsor:
Agency:
Jiuda Zhao
Agency class:
Other
Source:
Affiliated Hospital of Qinghai University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06601621
