Breast Cancer Survivors Receiving Aromatase Inhibitor Therapy Clinical Trial
Official title:
Evaluating the Impact of Baduanjin Exercise Intervention on Quality of Life in Breast Cancer Survivors Receiving Aromatase Inhibitor Therapy：: A Pilot Study
| Verified date | July 2020 |
| Source | Guangdong Provincial People's Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 86 |
| Est. completion date | November 10, 2018 |
| Est. primary completion date | November 10, 2017 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 70 Years |
| Eligibility |
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 In?ammatory 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 in?ammatory 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 |
| Country | Name | City | State |
|---|---|---|---|
| China | Guangdong General Hospital | Guangzhou | Guangdong |
| Lead Sponsor | Collaborator |
|---|---|
| Guangdong Provincial People's Hospital | Guangzhou Sport University |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change from Baseline Quality of Life (QoL) at 3 months | European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 version 3 (EORTC QLQ-C30) | at baseline and 3 months | |
| Secondary | Change from Baseline IL-6 at 3 months | proin?ammatory cytokines interleukin-6 | at baseline and 3 months | |
| Secondary | Change from Baseline Fatigue at 3 months | Piper fatigue questionnaire | at baseline and 3 months | |
| Secondary | Change from Baseline sleep quality at 3 months | Pittsburgh sleep quality index, PSQI | at baseline and 3 months | |
| Secondary | Change from Baseline Aromatase Inhibitor-Induced Arthralgia at 3 months | Brief Pain Inventory-Short Form | at baseline and 3 months | |
| Secondary | Change from Baseline Symptoms of climacteric syndrome at 3 months | Kupperman Index | at baseline and 3 months | |
| Secondary | Change from Baseline BMD at 3 months | Bone mineral density | at baseline and 3 months | |
| Secondary | Change from Baseline BMI at 3 months | Body Mass Index | at baseline and 3 months | |
| Secondary | Change from Baseline Aerobic Fitness Assessment at 3 months | Six-min walk test (6MWT) | at baseline and 3 months | |
| Secondary | Change from Baseline Muscle strength test at 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) | at baseline and 3 months | |
| Secondary | Change from Baseline Flexibility test at 3 months | Test of scratching his back and Sit in the chair and reach | at baseline and 3 months | |
| Secondary | Change from Baseline Balance test at 3 months | stand on one foot | at baseline and 3 months | |
| Secondary | Change from Baseline TNF-a at 3 months | tumor necrosis factor alpha | at baseline and 3 months | |
| Secondary | Change from Baseline IL-1ß at 3 months | interleukin-1ß | at baseline and 3 months | |
| Secondary | Change from Baseline CRP at 3 months | C-reactive protein | at baseline and 3 months |