Aromatase inhibitor-associated musculoskeletal symptoms Signs and Symptoms
Conditions
Interventions
The 84 eligible participants are randomly allocated to two different groups:
1. Treatment group: Calcium carbonate and vitamin D3 tablets (Ca 600mg+ vitD3 125IU per tablet, 2 tablets per day) twice a
Sponsors
Beijing Municipal Science and Technology Commission (China)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Stage I-III breast cancer with no evidence of recurrence and metastasis, completed chemotherapy and/or radiotherapy 2. Use of a third-generation aromatase inhibitor (AI) and self-report ongoing musculoskeletal symptoms after initiation of aromatase inhibitor (AI) therapy 3. A baseline worst pain score over the past week on the Brief Pain Inventory-Short Form (BPI-SF) of =3 points on a scale of 0 to 10 4. Traditional Chinese Medicine (TCM) syndrome is differentiated as deficiency of liver and kidney, qi and collaterals stagnation 5. Anticipated survival time is more than six months 6. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 7. All patients provided written informed consent before enrollment
Exclusion criteria
Exclusion criteria: 1. Patients with endocrine and any other diseases influencing bone metabolism (hyperthyroidism, hypothyroidism, diabetes, chusing syndrome, chronic liver disease, nephropathy, myeloma, bone tumor, bone metastasis) 2. Use of the agents influencing bone metabolism (glucocorticoid, thyroid hormone, heparin, anticonvulsant, diuretic, bisphosphonates) except calcium within the past three months 3. Contraindication in calcium agent and vitamin D 4. Diagnosis of primary osteoarticular diseases 5. Complicated with other primary tumors and serious heart, liver, kidney and hematopoietic system diseases 6. Pregnancy, mental illness and cognitive handicap
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The Brief Pain Inventory-Short Form (BPI-SF) to evaluate general pain 2. Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index to assess joint pain, stiffness, and functional status in the knees. 3. The Modified Score for the Assessment and quantification of Chronic Rheumatoid Affections fo the hands (M-SACRAH) to assess joint pain, stiffness, and functional status in the hands. The outcome measures above will be assessed before the treatment, at 1 month, 2 and 3 months during the treatment, the assessments will be repeated at the third month after the treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The Functional Assessment of Cancer Therapy breast cancer-specific quality of life tool (FACT-B) to evaluate quality of life of patients with breast cancer. 2. TCM symptoms scale to evaluate TCM syndrome (deficiency of liver and kidney, qi and collaterals stagnation). 3. Bone Mineral Density (BMD) to evaluate bone density and bone metabolism objectively 4. Bone Metabolic Markers (calcium, phosphorus, alkaline phosphatase, osteocalcin, calcitonin) to evaluate bone density and bone metabolism objectively FACT-B and TCM syndrome will be assessed before the treatment, at 1 month, 2 and 3 months during the treatment, the assessments will be repeated at the third month after the treatment. BMD and bone metabolic markers will be assessed before and after the treatment. | — |
Countries
China
Outcome results
None listed