Clinical trial NCT03162133: Evaluating the Impact of Baduanjin Exercise Intervention on Quality of Life in Breast Cancer Survivors Receiving Aromatase Inhibitor Therapy
Official title: Evaluating the Impact of Baduanjin Exercise Intervention on Quality of Life in Breast Cancer Survivors Receiving Aromatase Inhibitor Therapy：: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Survivors Receiving Aromatase Inhibitor Therapy
Keywords: Breast Cancer
Aromatase Inhibitor Therapy
Baduanjin Exercise
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
Collaborators: name: Guangzhou Sport University
First posted: 2017-05-22
Enrollment: 86
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline Quality of Life (QoL) at 3 months
timeFrame: at baseline and 3 months
Secondary outcomes:
measure: Change from Baseline IL-6 at 3 months
timeFrame: at baseline and 3 months
measure: Change from Baseline Fatigue at 3 months
timeFrame: at baseline and 3 months
measure: Change from Baseline sleep quality at 3 months
timeFrame: at baseline and 3 months
measure: Change from Baseline Aromatase Inhibitor-Induced Arthralgia at 3 months
timeFrame: at baseline and 3 months
measure: Change from Baseline Symptoms of climacteric syndrome at 3 months
timeFrame: at baseline and 3 months
measure: Change from Baseline BMD at 3 months
timeFrame: at baseline and 3 months
measure: Change from Baseline BMI at 3 months
timeFrame: at baseline and 3 months
measure: Change from Baseline Aerobic Fitness Assessment at 3 months
timeFrame: at baseline and 3 months
measure: Change from Baseline Muscle strength test at 3 months
timeFrame: at baseline and 3 months
measure: Change from Baseline Flexibility test at 3 months
timeFrame: at baseline and 3 months
measure: Change from Baseline Balance test at 3 months
timeFrame: at baseline and 3 months
measure: Change from Baseline TNF-α at 3 months
timeFrame: at baseline and 3 months
measure: Change from Baseline IL-1β at 3 months
timeFrame: at baseline and 3 months
measure: Change from Baseline CRP at 3 months
timeFrame: at baseline and 3 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong General Hospital
state: Guangdong
Study officials:
affiliation: Guangdong Provincial People's Hospital
name: Kun Wang
role: PRINCIPAL_INVESTIGATOR
References: