aromatase inhibitor-associated musculoskeletal symptom in postmenopausal breast cancer patients
Conditions
Interventions
group 1:acupoint thread embedding combined with Wenshen Bugu Decoction
group 2:Wenshen Bugu Decoction
Sponsors
Yueyang Hospital of Integrated Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
Female
Age
45 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 45-75 years old, postmenopausal women who meet any of the following conditions can be considered to have reached the menopausal state: (1) After bilateral oophorectomy; (2) Age >= 60 years old; (3) Age = 12 months, no chemotherapy, tamoxifen, toremifene or ovarian castration in the past year, FSH and estradiol reach postmenopausal levels; (4) Age = 1 month, and plan to continue taking AIs during the study; 4. One or more bone and joint pain and (or) stiffness after taking AIs, or the previous bone and joint pain and (or) stiffness were significantly aggravated; 5. In the past week, the Brief Pain Inventory-Worst Pain score (BPI-WP) >= 3 points; 6. The activity status score of the Eastern Cooperative Oncology Group (ECOG) is 0~2 (means that the activity ability is completely normal, and there is no difference from the activity ability before the onset of the disease; means walking freely and engaging in activities; Light physical activity, including general housework or office work, but cannot engage in heavy physical activity; means that you can move around freely and take care of yourself, but you have lost the ability to work, and you can get up for activities at least half of the day); 7. Volunteer to participate in the trial and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. History of fracture or bone and joint surgery within 6 months; 2. Suffering from rheumatoid arthritis, rheumatoid arthritis, ankylosing spondylitis and other rheumatic diseases; 3. Have used non-steroidal anti-inflammatory drugs, opioid painkillers, or any other drugs for joint pain or joint stiffness in the past 1 month; 4. There are ATE contraindications, such as allergies to embedding materials, severe bleeding tendency, etc.; 5. Recurrent and metastatic breast cancer, or combined with other primary malignant tumors; 6. Combined with autoimmune diseases, serious diseases of heart, brain, kidney and other organs, infectious diseases, mental and behavioral abnormalities that are not convenient for observation; 7. Received acupuncture treatment for joint symptoms caused by AIs or received acupuncture treatment within 1 month before the start of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Brief pain inventory- worst pain (BPI-WP); | — |
Secondary
| Measure | Time frame |
|---|---|
| The response rate;Brief pain inventory- short form (BPI-SF);Western Ontario and Mcmaster Universities Osteoarthritis Index (WOMAC);Functional Assessment of Cancer Therapy-Endocrine Symptom (FACT-ES);Patient-reported outcome (PRO);bone marrow density (BMD);Bone metabolism;Morisky medication adherence scale-8 (MMAS-8);Survival follow-up;Credibility and expectancy; | — |
Countries
China
Contacts
Public ContactJi Yajie
Yueyang Hospital of Integrated Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
Outcome results
None listed