Bone and Joint Related Symptom Clusters in Breast Cancer Survivors
Conditions
Interventions
experimental group:Third Generation Aromatase Inhibitors, Jian Gu Tong Luo Formula, Calcium Carbonate and Vitamin D3 Tablets
control group:Third Generation Aromatase Inhibitors, Placebo, Calcium Carbonate and Vitamin D3 Tablets
Sponsors
Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Female aged 18 to 75 years old; (2) Breast cancer patients with clear pathological diagnosis in stages I to IIIA positive for hormone receptor and negative for HER2 gene who have completed surgery radiotherapy and chemotherapy and have been confirmed through examination to have no tumor recurrence or metastasis; (3) ECOG-PS score of 0 to 1; (4) Postmenopausal women or women who have used ovarian function inhibitors for = 3 months and whose hormone levels have reached the postmenopausal standard and who have received treatment with third-generation AIs (anastrozole letrozole or exemestane) for = 3 months and plan to continue taking AIs during the study period; (5) According to the VAS scale the scores of each symptom of bone and joint related symptom clusters (bone/joint pain-numbness-stiffness) of the included population are = 4 points; (6) Traditional Chinese medicine syndrome differentiation shows deficiency of both liver and kidney and obstruction of meridians and collaterals; (7) Having certain abilities of understanding and expression voluntarily participating in this study and signing the informed consent.
Exclusion criteria
Exclusion criteria: (1) Have used CDK4/6 inhibitors within the past month including palbociclib abemaciclib darsicilib ribociclib etc. (2) Have a history of fracture or orthopedic surgery of the bone and joint within the past 6 months; (3) Have knee osteoarthropathy that affects the determination of symptoms in this study as confirmed by X-ray CT pathological examination etc.; (4) Suffer from rheumatic diseases such as rheumatoid arthritis ankylosing spondylitis etc.; (5) Have used non-steroidal anti-inflammatory drugs opioid analgesics or any other drugs for treating joint pain or joint stiffness within the past month; (6) Have an allergic constitution or have had allergic reactions to traditional Chinese medicines or have been confirmed to be allergic to the components of the Jian Gu Tong Luo prescription; (7) Are expected to have the progression of invasive breast cancer during the study period and require radiotherapy; (8) Have other malignancies or have severe heart liver and kidney dysfunction (laboratory indicators are more than twice the upper limit of the normal value); (9) Have severe comorbidities active infections severe bleeding tendencies or abnormal hematopoietic function; (10) Have active hepatitis B active hepatitis C a history of human immunodeficiency virus (HIV) infection or other acquired or congenital immunodeficiency diseases; (11) Pregnant or lactating women or women of childbearing age who are unwilling to take effective contraceptive measures during the entire trial period; (12) Patients who are participating in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Western Ontario and McMaster Universities Arthritis Index (WOMAC) score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Visual Analogue Scale (VAS) score for the bone and joint symptom clusters (pain-numbness-stiffness);Functional Assessment of Cancer Therapy Breast;Six items of sex hormones;Bone mineral density;Bone metabolism markers;Score for the Modified Assessment and Quantification of Chronic Rheumatoid Affections of the Hands;The Brief Pain Inventory-Short Form (BPI-SF);Traditional Chinese Medicine Syndrome Score Scale; | — |
Countries
China
Contacts
Public ContactGanlin Zhang
Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University
Outcome results
None listed