Breast CancerYogaNCT00476203
Yoga Study in Breast Cancer Patients
A study testing Yoga and Delayed yoga classes in people with Breast Cancer, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial summary
This purpose of this study is to test whether a 6-month yoga program improves quality of life and reduces fatigue and weight gain in breast cancer survivors. Read more about this study
- Who is it for?
- Ages 21 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Yoga and Delayed yoga classes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to May 2011
- 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 21 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- Age 21-75
- Diagnosed with a primary breast cancer Stage 0-IIIa
- Current tamoxifen or aromatase inhibitor use is allowed
- At least 3 months post treatment (e.g., surgery, chemotherapy, or radiation therapy)
- BMI: 24 kg/m2 or greater (If Asian or Asian-American BMI: 23 kg/m2 or greater)
Show all 9Show fewer
- No contraindications to participating in a yoga program
- Able to come for clinic visits, and attend weekly classes, and fill out questionnaires and logs in English
- Gives informed consent, agrees to be randomly assigned
Who cannot join
- Plans to leave the study area within the follow-up period
- Is pregnant or plans to become pregnant during the study period.
- History of myocardial infarction (heart attack) or stroke in the previous 6 months, or diabetes (current diagnosis)
- Has practiced yoga more than 1 time per month in the past six months.
- Current use of medications likely to interfere with adherence to interventions or study outcomes
- Alcohol or drug abuse, significant mental illness (as assessed by study staff impression)
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
About this study
Official title: Effect of Yoga on Weight and Fatigue in Breast Cancer Patients Study
This purpose of this study is to test whether a 6-month yoga program improves quality of life and reduces fatigue and weight gain in breast cancer survivors.
Read the detailed description
Women who are overweight or obese have a higher risk of breast cancer than normal weight women. Furthermore, women who are overweight or obese or gain weight after diagnosis have an increased risk of recurrence or dying from breast cancer compared with normal weight women. Yoga has been associated with reduced weight gain and weight loss in persons without cancer. However, no studies have tested whether yoga leads to less weight gain or weight loss in breast cancer patients. Both obesity and the sequelae of breast cancer therapy can result in reduced health-related quality of life and severe fatigue, which may also be favorably affected by yoga practice. The specific aims of the proposed trial are to examine, in women with Stage 0-IIIa breast cancer who are at least 3 months post primary treatment for their disease (other than tamoxifen or aromatase inhibitors), the effects of a 6-month yoga intervention on health-related quality of life, fatigue, and body weight.
- Conditions
- Breast Cancer
- Being tested
- Yoga, Delayed yoga classes
- Keywords
- Breast Cancer, Yoga, Quality of Life, Obesity, Fatigue, Weight
- Medical subject headings
- Breast Neoplasms, Obesity, Fatigue, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YogaBehavioural
Instructor-led yoga classes 1/time per week + 4 days of home practice
Delayed yoga classesOther
Delayed yoga classes (after 6 months) offered [wait list control group]
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Immediate yoga classes offered Receives: Behavioral: Yoga |
| 2 | Other | Delayed yoga classes (after 6 months) offered [wait list control group] Receives: Other: Delayed yoga classes |
What is being measured
The primary outcome is the main question the study is designed to answer.
quality of life, fatigue, and body weight
Measured: baseline, 6 months, 12 months
Secondary outcomes (1)
waist and hip circumference
Measured: baseline, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2007 (estimated)
- Study startMay 2007
- Primary completionMay 2010
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Investigators
- Alyson Littman, PhD, Study director, Department of Epidemiology, UWAnne McTiernan, MD, PhD, Principal investigator, Fred Hutchinson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00476203
- Sponsor's protocol ID
- PHS - 6434
- Other IDs
- U54CA116847-01
- Acronym
- Yoga
- Status last verified
- Nov 2012
- First submitted
- 17 May 2007
- Last updated
- 28 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Littman AJ, Bertram LC, Ceballos R, Ulrich CM, Ramaprasad J, McGregor B, McTiernan A. Randomized controlled pilot trial of yoga in overweight and obese breast cancer survivors: effects on quality of life and anthropometric measures. Support Care Cancer. 2012 Feb;20(2):267-77. doi: 10.1007/s00520-010-1066-8. Epub 2011 Jan 5.
PubMed 21207071
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Yoga on Weight and Fatigue in Breast Cancer Patients Study
- ClinicalTrials.gov ID
- NCT00476203
- Acronym / sponsor ID
- Yoga / PHS - 6434
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Yoga, Quality of Life, Obesity, Fatigue, Weight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- May 2007
- Primary completion
- May 2010 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 21 May 2007 (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.
This purpose of this study is to test whether a 6-month yoga program improves quality of life and reduces fatigue and weight gain in breast cancer survivors.
Detailed description
Women who are overweight or obese have a higher risk of breast cancer than normal weight women. Furthermore, women who are overweight or obese or gain weight after diagnosis have an increased risk of recurrence or dying from breast cancer compared with normal weight women. Yoga has been associated with reduced weight gain and weight loss in persons without cancer. However, no studies have tested whether yoga leads to less weight gain or weight loss in breast cancer patients. Both obesity and the sequelae of breast cancer therapy can result in reduced health-related quality of life and severe fatigue, which may also be favorably affected by yoga practice. The specific aims of the proposed trial are to examine, in women with Stage 0-IIIa breast cancer who are at least 3 months post primary treatment for their disease (other than tamoxifen or aromatase inhibitors), the effects of a 6-month yoga intervention on health-related quality of life, fatigue, and body weight.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: YogaImmediate yoga classes offered |
| 2 | Other | Other: Delayed yoga classesDelayed yoga classes (after 6 months) offered [wait list control group] |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Female
- Age 21-75
- Diagnosed with a primary breast cancer Stage 0-IIIa
- Current tamoxifen or aromatase inhibitor use is allowed
- At least 3 months post treatment (e.g., surgery, chemotherapy, or radiation therapy)
Key exclusion criteria (6 listed)
- Plans to leave the study area within the follow-up period
- Is pregnant or plans to become pregnant during the study period.
- History of myocardial infarction (heart attack) or stroke in the previous 6 months, or diabetes (current diagnosis)
- Has practiced yoga more than 1 time per month in the past six months.
- Current use of medications likely to interfere with adherence to interventions or study outcomes
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 |
|---|---|---|
| YogaInstructor-led yoga classes 1/time per week + 4 days of home practice | Behavioural | 1 |
| Delayed yoga classesDelayed yoga classes (after 6 months) offered [wait list control group] | Other | 2 |
Primary outcome
quality of life, fatigue, and body weight
Time frame: baseline, 6 months, 12 months
1 secondary outcome
waist and hip circumference
Time frame: baseline, 6 months, 12 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 28 Nov 2012.
- Results publication: PubMed 21207071Littman AJ, Bertram LC, Ceballos R, Ulrich CM, Ramaprasad J, McGregor B, McTiernan A. Randomized controlled pilot trial of yoga in overweight and obese breast cancer survivors: effects on quality of life and anthropometric measures. Support Care Cancer. 2012 Feb;20(2):267-77. doi: 10.1007/s00520-010-1066-8. Epub 2011 Jan 5.
- Yoga for breast cancer patients study home pageLink provided by the sponsor.
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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.
Alyson Littman, PhD study director
Department of Epidemiology, UW
Anne McTiernan, MD, PhD principal investigator
Fred Hutchinson Cancer Center
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 and Delayed yoga classes in people with Breast Cancer, run by Fred Hutchinson Cancer Center at 1 site in United States.
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 9 inclusion and 6 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 28 Nov 2012. 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 United States. 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?
quality of life, fatigue, and body weight (time frame: baseline, 6 months, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00476203, which also lists 1 linked publication.
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 28 Nov 2012.