Breast Cancer Survivors Receiving Aromatase Inhibitor Therapy
Conditions
Keywords
Breast Cancer, Aromatase Inhibitor Therapy, Baduanjin Exercise
Brief summary
A 12-week randomized controlled trail was conducted in 72 Chinese breast cancer survivors who had received aromatase inhibitors treatment for more than 6 months. All participants were assigned to either 12 weeks of Baduanjin classes which involved to two 90-minute sessions per week or a wait-list control. Participants completed fitness assessments, measurements of lipopolysaccharide-stimulated production of proinflammatory cytokines interleukin-6 (IL-6), tumor necrosis factor alpha (TNF-α), interleukin-1β(IL-1β) ,C-reactive protein (CRP) ，BMI，BMD and questionnaires to measure QoL, fatigue, sleep quality, Aromatase Inhibitor-Induced Arthralgia, symptoms of climacteric syndrome were completed at baseline and 3 months.
Interventions
OTHERBaduanjin exercise
Sponsors
Guangzhou Sport University
Guangdong Provincial People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Have been diagnosed as stage I to III breast cancer 0.5 to 4.0 years before enrollment * Taking an AI (aromatase inhibitors )，and had been receiving an AI for at least 6 months
Exclusion criteria
* A prior history of breast or any other cancer except basal or squamous cell skin cancer Inflammatory breast cancer * With exercise contraindications：chronic obstructive pulmonary disease, uncontrolled hypertension, evidence of liver or kidney failure, symptomatic ischemic heart disease ,conditions involving the immune system such as autoimmune and/or inflammatory diseases, cognitive impairment, alcohol/drug abuse * Current Baduanjin practice (within the last 6 months), and/or previous Baduanjin practice for more than 3 months * Women reporting 5 hours or more of vigorous physical activity per week
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline Quality of Life (QoL) at 3 months | at baseline and 3 months | European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 version 3 (EORTC QLQ-C30) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline BMD at 3 months | at baseline and 3 months | Bone mineral density |
| Change from Baseline BMI at 3 months | at baseline and 3 months | Body Mass Index |
| Change from Baseline Aerobic Fitness Assessment at 3 months | at baseline and 3 months | Six-min walk test (6MWT) |
| Change from Baseline IL-6 at 3 months | at baseline and 3 months | proinflammatory cytokines interleukin-6 |
| Change from Baseline Fatigue at 3 months | at baseline and 3 months | Piper fatigue questionnaire |
| Change from Baseline sleep quality at 3 months | at baseline and 3 months | Pittsburgh sleep quality index, PSQI |
| Change from Baseline Symptoms of climacteric syndrome at 3 months | at baseline and 3 months | Kupperman Index |
| Change from Baseline Muscle strength test at 3 months | at baseline and 3 months | Upper strength: hand grip (measured by a dynamometer; the average of 3 readings) lower limb strength：sit-to-stand (measured as number of reps in a 30-s period) |
| Change from Baseline Flexibility test at 3 months | at baseline and 3 months | Test of scratching his back and Sit in the chair and reach |
| Change from Baseline Balance test at 3 months | at baseline and 3 months | stand on one foot |
| Change from Baseline TNF-α at 3 months | at baseline and 3 months | tumor necrosis factor alpha |
| Change from Baseline IL-1β at 3 months | at baseline and 3 months | interleukin-1β |
| Change from Baseline CRP at 3 months | at baseline and 3 months | C-reactive protein |
| Change from Baseline Aromatase Inhibitor-Induced Arthralgia at 3 months | at baseline and 3 months | Brief Pain Inventory-Short Form |
Countries
China
Outcome results
None listed