Female Breast CarcinomaNCT02243163
Effect of Yoga on Life Quality and Immunity in Breast Cancer Patients After Operation and or Chemotherapy
A study testing Yoga exercise in people with Female Breast Carcinoma, run by Chang Bing Show Chwan Memorial Hospital at 1 site in Taiwan.
Trial summary
The purpose of study is to investigate if yoga exercise improve life quality and immune status in breast cancer patients after complete treatment (including surgery and / or radiotherapy and / or chemotherapy) Read more about this study
- Who is it for?
- Ages 20 to 65 years, women only
- Conditions the study is for
- Female Breast Carcinoma
- What is being tested?
- Yoga exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- May 2014to Apr 2015
- 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 20 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to attend yoga program weekly, and fill out inform consent.
- Patients with breast cancer after complete treatment for at least 3 months (including surgery and / or radiotherapy and/or chemotherapy).
Who cannot join
- male
- overweight
- unable to do yoga exercise.
Trial locations and contacts
1 site in 1 country.
Shin-Mae Wang, MD. contact
Shu-Hui Yeh Yeh, PhD contact
Taiwan1 site, 1 recruiting
- Recruiting
Division of Core Laboratory; Chang Bing Show Chwan Memorial Hospital
Changhua County
Kuender D. Yang, PhD, 886-975617006, yangkd.yeh@hotmail.com
About this study
The purpose of study is to investigate if yoga exercise improve life quality and immune status in breast cancer patients after complete treatment (including surgery and / or radiotherapy and / or chemotherapy)
Read the detailed description
It is well-known that exercise promote immune regulation for better life quality. However, the mechanism for better immunity and life quality is not clear. We postulate that Ayurveda yoga might benefit breast cancer women with completion of operation and/or chemotherapy and radiotherapy. The benefits could be due to immune modulation, and improve health perception and life quality, and even potential decrease of cancer relapse.
The study patients will do yoga twice a week for 12 weeks. The study primary endpoints are 1) to improve personal health perception, 2) to improve life quality and 3) to enhance human immunity. The study secondary endpoint will follow up the immunity changes 3 months after the intervention.
We anticipate to reach the primary endpoints and to publish the primary results in one year, the secondary endpoint will complete in the second year.
- Conditions
- Female Breast Carcinoma
- Being tested
- Yoga exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga exerciseBehavioural
Subjects will receive regular 90-minutes yoga classes twice a week for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Yoga exercise | Experimental | Subjects will receive regular 90-minutes yoga classes twice a week for 3 months. Receives: Behavioral: Yoga exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improve personal health and life quality
Health and life quality will assessed by modified fatigue inventory and EORTC QLQ-C30 (version 3) at three different times: (1)baseline data: before yoga exercise, (2)outcome data: at 6 and 12 weeks post-test.
Measured: Change from baseline in personal health and life quality at 6 months.
Secondary outcomes (1)
Immune modulation
Lymphocytes will be extracted from peripheral blood for analyses of lymphocytes subpopulation (Th1/ Th2/ Treg/ Th17), polarization (T-bet/ Gata-3/ Foxp3/ RORrt) and its related cytokines (Th1: IL-12/ IFN-γ/ IL-27; Th2: IL-4/ IL-13/ IL-25; Th17: IL-17A/ IL-6/ IL-21; Treg: TGF/ IL-10. Saliva collection for analyses of cortisol and IL-6 at 3 different times: (1) baseline data: before yoga exercise, (2)outcome data: at 6 and 12 weeks post-test.
Measured: Change from baseline in human immunity at 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2014 (estimated)
- Study startMay 2014
- Primary completionApr 2015 (estimated)
- Study completionApr 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Breast CarcinomaStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Bing Show Chwan Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shu-Hui Yeh, Chang Bing Show Chwan Memorial Hospital
- Investigators
- Shu-Hui Yeh, PhD, Study chair, Chang Bing Show Chwan Memorial Hospital & Central Taiwan University of Science and TechnologyKuender D. Yang, PhD, Study director, Chang Bing Show Chwan Memorial HospitalShin-Mae Wang, MD., Principal investigator, Show Chwan Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02243163
- Sponsor's protocol ID
- 1020106
- Status last verified
- Sep 2014
- First submitted
- 16 Sep 2014
- Last updated
- 17 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Yoga on Life Quality and Immunity in Breast Cancer Patients After Operation and or Chemotherapy
- ClinicalTrials.gov ID
- NCT02243163
- Acronym / sponsor ID
- 1020106
- Conditions
- Female Breast Carcinoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Chang Bing Show Chwan Memorial HospitalUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Apr 2015 (estimated)
- Study completion
- Apr 2015 (estimated)
- First posted
- 17 Sep 2014 (estimated)
- 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.
The purpose of study is to investigate if yoga exercise improve life quality and immune status in breast cancer patients after complete treatment (including surgery and / or radiotherapy and / or chemotherapy)
Detailed description
It is well-known that exercise promote immune regulation for better life quality. However, the mechanism for better immunity and life quality is not clear. We postulate that Ayurveda yoga might benefit breast cancer women with completion of operation and/or chemotherapy and radiotherapy. The benefits could be due to immune modulation, and improve health perception and life quality, and even potential decrease of cancer relapse.
The study patients will do yoga twice a week for 12 weeks. The study primary endpoints are 1) to improve personal health perception, 2) to improve life quality and 3) to enhance human immunity. The study secondary endpoint will follow up the immunity changes 3 months after the intervention.
We anticipate to reach the primary endpoints and to publish the primary results in one year, the secondary endpoint will complete in the second year.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Yoga exercise | Experimental | Behavioral: Yoga exerciseSubjects will receive regular 90-minutes yoga classes twice a week for 3 months. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Able to attend yoga program weekly, and fill out inform consent.
- Patients with breast cancer after complete treatment for at least 3 months (including surgery and / or radiotherapy and/or chemotherapy).
Key exclusion criteria (3 listed)
- male
- overweight
- unable to do yoga exercise.
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 |
|---|---|---|
| Yoga exerciseSubjects will receive regular 90-minutes yoga classes twice a week for 3 months. | Behavioural | Yoga exercise |
Primary outcome
Improve personal health and life quality
Time frame: Change from baseline in personal health and life quality at 6 months.
Health and life quality will assessed by modified fatigue inventory and EORTC QLQ-C30 (version 3) at three different times: (1)baseline data: before yoga exercise, (2)outcome data: at 6 and 12 weeks post-test.
1 secondary outcome
Immune modulation
Time frame: Change from baseline in human immunity at 3 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2014.
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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.
Shin-Mae Wang, MD. contact
Shu-Hui Yeh Yeh, PhD contact
Shu-Hui Yeh, PhD study chair
Chang Bing Show Chwan Memorial Hospital & Central Taiwan University of Science and Technology
Kuender D. Yang, PhD study director
Chang Bing Show Chwan Memorial Hospital
Shin-Mae Wang, MD. principal investigator
Show Chwan Memorial 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 Yoga exercise in people with Female Breast Carcinoma, run by Chang Bing Show Chwan Memorial Hospital at 1 site in Taiwan.
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 3 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: status not confirmed, as of the sponsor's last update on 17 Sep 2014. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shin-Mae Wang, MD. (wangznmg@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improve personal health and life quality (time frame: Change from baseline in personal health and life quality at 6 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 17 Sep 2014.