Breast cancer
Conditions
Interventions
Control group:Conventional treatment
Experimental group:Baduanjin and conventional treatment
Sponsors
Guangdong Provincial Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Female aged 18-70 years; (2) Pathologically confirmed invasive ductal carcinoma; pathological stage I II or III with no evidence of metastatic disease (M0); (3) Patients must have undergone surgical treatment for breast cancer with negative margins and must have recovered from all side effects of the surgery; (4) According to institutional standards the patient's estrogen receptor (ER) and/or progesterone receptor (PgR) must be positive; (5) Patients must have started taking a third-generation aromatase inhibitor (AI)anastrozole letrozole or exemestaneat least 30 days prior to enrollment and plan to continue taking it for at least 1 year after enrollment; patients may switch AIs but must be on a stable dose for at least 30 days; concurrent use of trastuzumab and/or pertuzumab is allowed; (6) Patients must have completed the S1200 Brief Pain Inventory-Short Form (BPI-SF) within 14 days prior to enrollment; patients must have a score of at least 3 on the worst pain item of the BPI-SF and the pain must have started or worsened since initiating AI therapy; (7) Patients must be willing to provide blood and urine samples for testing serum hormones (estradiol FSH LH) and inflammatory biomarkers (serum TNFa IL-6 IL-12 CRP and urinary CTX-II) and agree to the use of remaining samples for future translational research; baseline samples must be obtained before starting the intervention; (8) ECOG performance status of 0 or 1 and assessed as able to tolerate subsequent treatment; (9) Voluntarily join the study sign informed consent have good compliance and be willing to cooperate with follow-up; (10) Patients must not have concurrent medical/arthritic conditions that may affect or interfere with pain or efficacy assessments including: inflammatory arthritis (e.g. rheumatoid arthritis systemic lupus erythematosus spondyloarthropathy psoriatic arthritis) gout acute monoarthritis consistent with pseudogout Paget's disease affecting the study joints (knee/hand joints) septic arthritis affecting the study avascular necrosis or a history of intra-articular fractures Wilson's disease hemochromatosis alkaptonuria or primary osteochondromatosis; (11) Patients must not have a history of knee and/or hand fractures or surgeries within 6 months prior to enrollment; (12) Patients must not have a medical history that in the opinion of the investigators may affect the study results or pose additional risks to the patient; (13) No prior history of other malignancies except for the following: adequately treated basal cell or squamous cell skin cancer carcinoma in situ of the cervix ductal carcinoma in situ (DCIS) adequately treated and currently in complete remission of stage I or II cancer or any other cancer that has been disease-free for more than 5 years.
Exclusion criteria
Exclusion criteria: (1) Patients who have received Baduanjin exercise therapy within the past 12 months or at any time in the past for joint symptoms; (2) Study participants who have used opioid analgesics topical analgesics oral corticosteroids intramuscular corticosteroids intra-articular steroids or any other drug therapy alternative therapy or physical therapy for joint pain or stiffness within 28 days prior to enrollment; (3) Patients with a history of fractures or surgery involving the affected knee hand or both within 6 months prior to enrollment; (4) Patients with severe brain disorders psychiatric diseases movement disorders obesity (BMI = 28 kg/m²) poor balance or other conditions that prevent them from cooperating with exercise interventions; (5) Patients with uncontrolled hypertension (systolic blood pressure = 180 mmHg or diastolic blood pressure = 100 mmHg); (6) Severe cardiovascular diseases such as severe heart failure or malignant arrhythmias; (7) Patients with severe pulmonary diseases severe diabetes severe liver or kidney dysfunction or other serious conditions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The BPI Worst Pain Item (BPI-WP) score after 12 weeks of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| The WOMAC score;Compliance with endocrine medications;The M-SACRAH score;The use of analgesics;Quality of life; | — |
Countries
China
Contacts
Public ContactXu Rui
Guangdong Provincial Hospital of Traditional Chinese Medicine
Outcome results
None listed