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Table 1 Eligibility criteria

From: Effects of the traditional Chinese medicine Yi Shen Jian Gu granules on aromatase inhibitor-associated musculoskeletal symptoms: a study protocol for a multicenter, randomized, controlled clinical trial

 

Inclusion criteria

1.

Pathologically confirmed stage I to III breast cancer with no recurrence and metastasis.

2.

Completed chemotherapy and/or radiotherapy.

3.

Currently using a third-generation aromatase inhibitor (anastrozole, letrozole, or exemestane) and self-reported ongoing musculoskeletal symptoms (arthralgia and/or stiffness and/or swelling in one or more joints, bone pain, myalgia, carpal tunnel syndrome, trigger finger), which started or worsened after initiation of aromatase inhibitor therapy and has continued for more than 1 month, and who had a baseline worst pain score over the past week on the Brief Pain Inventory-Short Form ≥3 points on a scale of 0 to 10.

4.

Eastern Cooperative Oncology Group performance status 0-2.

5.

Provided written informed consent before enrollment.

 

Exclusion criteria

1.

Patients with endocrine and any other diseases influencing bone metabolism (for example, hyperthyroidism, hypothyroidism, diabetes, Cushing’s syndrome, chronic liver disease, nephropathy, myeloma, bone tumor, or bone metastasis).

2.

Used of agents influencing bone metabolism (for example, glucocorticoid, thyroid hormone, heparin, anticonvulsants, diuretics, or bisphosphonates), except calcium agents, within the past 3 months.

3.

Contraindications to calcium agents and vitamin D.

4.

Diagnosed with primary osteoarticular diseases.

5.

Presence of other primary tumors and severe heart, liver, kidney, and hematopoietic system diseases.

6.

Presence of pregnancy, mental illness, or cognitive handicap.