Breast Cancer Survivors Receiving Aromatase Inhibitor TherapyNCT03162133
Evaluating the Impact of Baduanjin Exercise Intervention on Quality of Life in Breast Cancer Survivors Receiving Aromatase Inhibitor Therapy
A study testing Baduanjin exercise in people with Breast Cancer Survivors Receiving Aromatase Inhibitor Therapy, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer Survivors Receiving Aromatase Inhibitor Therapy
- What is being tested?
- Baduanjin exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteChina
- Study dates
- 10 Nov 2016to 10 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Impact of Baduanjin Exercise Intervention on Quality of Life in Breast Cancer Survivors Receiving Aromatase Inhibitor Therapy：: A Pilot Study
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.
- Being tested
- Baduanjin exercise
- Keywords
- Breast Cancer, Aromatase Inhibitor Therapy, Baduanjin Exercise
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baduanjin exerciseOther
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Experimental | After completing the baseline tests, participants in exercise group were instructed to attend 90-minute, supervised Baduanjin exercise 2 times per week. The Baduanjin intervention used the standardized Baduanjin training program, designed by the General Administration of Sports of China. Two senior Baduanjin teachers from Guangzhou Sports University conducted the training. Receives: Other: Baduanjin exercise |
| Waiting list Control group | Experimental | Participants assigned to the wait-list control were told to continue performing their usual care and daily activities, and to refrain from doing any Baduanjin exercise.
After their post-assessment they were able to attend the Baduanjin classes. Receives: Other: Baduanjin exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: at baseline and 3 months
Secondary outcomes (14)
Change from Baseline IL-6 at 3 months
proinflammatory cytokines interleukin-6
Measured: at baseline and 3 months
Change from Baseline Fatigue at 3 months
Piper fatigue questionnaire
Measured: at baseline and 3 months
Change from Baseline sleep quality at 3 months
Pittsburgh sleep quality index, PSQI
Measured: at baseline and 3 months
Change from Baseline Aromatase Inhibitor-Induced Arthralgia at 3 months
Brief Pain Inventory-Short Form
Measured: at baseline and 3 months
Change from Baseline Symptoms of climacteric syndrome at 3 months
Kupperman Index
Measured: at baseline and 3 months
Change from Baseline BMD at 3 months
Bone mineral density
Measured: at baseline and 3 months
Change from Baseline BMI at 3 months
Body Mass Index
Measured: at baseline and 3 months
Change from Baseline Aerobic Fitness Assessment at 3 months
Six-min walk test (6MWT)
Measured: at baseline and 3 months
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)
Measured: at baseline and 3 months
Change from Baseline Flexibility test at 3 months
Test of scratching his back and Sit in the chair and reach
Measured: at baseline and 3 months
Change from Baseline Balance test at 3 months
stand on one foot
Measured: at baseline and 3 months
Change from Baseline TNF-α at 3 months
tumor necrosis factor alpha
Measured: at baseline and 3 months
Change from Baseline IL-1β at 3 months
interleukin-1β
Measured: at baseline and 3 months
Change from Baseline CRP at 3 months
C-reactive protein
Measured: at baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2017
- Study start10 Nov 2016
- Primary completion10 Nov 2017
- Study completion10 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer Survivors Receiving Aromatase Inhibitor TherapyStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Guangzhou Sport University
- Responsible party
- Principal investigator, KunWang, Guangdong Provincial People's Hospital
- Investigators
- Kun Wang, Principal investigator, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03162133
- Sponsor's protocol ID
- 20170217
- Status last verified
- Jul 2020
- First submitted
- 12 May 2017
- Last updated
- 29 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of Baduanjin Exercise Intervention on Quality of Life in Breast Cancer Survivors Receiving Aromatase Inhibitor Therapy：: A Pilot Study
- ClinicalTrials.gov ID
- NCT03162133
- Acronym / sponsor ID
- 20170217
- Keywords
- Breast Cancer, Aromatase Inhibitor Therapy, Baduanjin Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Collaborators
- Guangzhou Sport University
- Study start
- 10 Nov 2016 (actual)
- Primary completion
- 10 Nov 2017 (actual)
- Study completion
- 10 Nov 2018 (actual)
- First posted
- 22 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Other: Baduanjin exerciseAfter completing the baseline tests, participants in exercise group were instructed to attend 90-minute, supervised Baduanjin exercise 2 times per week. The Baduanjin intervention used the standardized Baduanjin training program, designed by the General Administration of Sports of China. Two senior Baduanjin teachers from Guangzhou Sports University conducted the training. |
| Waiting list Control group | Experimental | Other: Baduanjin exerciseParticipants assigned to the wait-list control were told to continue performing their usual care and daily activities, and to refrain from doing any Baduanjin exercise. After their post-assessment they were able to attend the Baduanjin classes. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Baduanjin exercise | Other | Exercise group, Waiting list Control group |
Primary outcome
Change from Baseline Quality of Life (QoL) at 3 months
Time frame: at baseline and 3 months
European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 version 3 (EORTC QLQ-C30)
14 secondary outcomes
Change from Baseline IL-6 at 3 months
Time frame: at baseline and 3 months
Change from Baseline Fatigue at 3 months
Time frame: at baseline and 3 months
Change from Baseline sleep quality at 3 months
Time frame: at baseline and 3 months
Change from Baseline Aromatase Inhibitor-Induced Arthralgia at 3 months
Time frame: at baseline and 3 months
Change from Baseline Symptoms of climacteric syndrome at 3 months
Time frame: at baseline and 3 months
Change from Baseline BMD at 3 months
Time frame: at baseline and 3 months
Change from Baseline BMI at 3 months
Time frame: at baseline and 3 months
Change from Baseline Aerobic Fitness Assessment at 3 months
Time frame: at baseline and 3 months
Change from Baseline Muscle strength test at 3 months
Time frame: at baseline and 3 months
Change from Baseline Flexibility test at 3 months
Time frame: at baseline and 3 months
Change from Baseline Balance test at 3 months
Time frame: at baseline and 3 months
Change from Baseline TNF-α at 3 months
Time frame: at baseline and 3 months
Change from Baseline IL-1β at 3 months
Time frame: at baseline and 3 months
Change from Baseline CRP at 3 months
Time frame: at baseline and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kun Wang principal investigator
Guangdong Provincial People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baduanjin exercise in people with Breast Cancer Survivors Receiving Aromatase Inhibitor Therapy, run by Guangdong Provincial People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Quality of Life (QoL) at 3 months (time frame: at baseline and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2020.