Breast CancerNCT00727662
A Yoga and Wellness Program for Breast Cancer Survivors With Persistent Fatigue
A study testing Iyengar Yoga and Wellness Seminar Series in people with Breast Cancer and Fatigue, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
Trial summary
This randomized controlled trial will compare the effectiveness of an Iyengar Yoga intervention to a Wellness Seminar health education lecture series, for improvements in energy, mood and biological functioning in breast cancer survivors with persistent, post-treatment fatigue. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women only
- Conditions the study is for
- Breast Cancer, Fatigue
- What is being tested?
- Iyengar Yoga and Wellness Seminar Series
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Dec 2010
- 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 40 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with early, resectable breast cancer (Stage I or II)
- Completed treatment with surgery, radiation, and/or chemotherapy between 6 months and 5 years previously
- No other cancer in last 5 years, including breast cancer recurrence
- Postmenopausal women
- Age 40 - 65
- Reporting persistent cancer-related fatigue
Who cannot join
- Evidence that fatigue is directly related to a medical or psychiatric disorder (e.g., untreated hypothyroidism, diabetes, anemia (defined as hematocrit < 24), chronic fatigue syndrome, current major depression, insomnia, sleep apnea, restless leg syndrome)
- Evidence that fatigue is related to other non-cancer related factors (e.g., shift work, recent change in activity or schedule)
- Physical problems or conditions that could make yoga unsafe (e.g., serious neck injuries, unstable joints; also severe cachexia, dizziness, bone pain, severe nausea, etc)
- Regular use of medications and/or behavioral therapies that would confound evaluation of IY, including regular participation in yoga classes
- Presence of medical conditions that involve the immune system and would confound immune evaluation (e.g., autoimmune disorder, inflammatory disease)
- Use of medications that might confound immune evaluation (e.g., regular use of corticosteroids, narcotics, opiates)
Show all 9Show fewer
- Unable to commit to intervention schedule
- Body mass index greater than 30 kg/m2
- Regular tobacco (defined as daily or near daily) or alcohol use (defined as > 2 drinks/day)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Cousins Center for PNI
Los Angeles, California, 90095
About this study
Official title: Iyengar Yoga for Breast Cancer Survivors With Persistent Fatigue
This randomized controlled trial will compare the effectiveness of an Iyengar Yoga intervention to a Wellness Seminar health education lecture series, for improvements in energy, mood and biological functioning in breast cancer survivors with persistent, post-treatment fatigue. It is anticipated that the Iyengar Yoga intervention will be feasible and acceptable to breast cancer survivors with minimal side effects and that the Yoga intervention will be effective in improving fatigue and physical performance.
Read the detailed description
Fatigue is the most common and distressing side effect of cancer treatment and persists beyond successful treatment completion in approximately 30% of breast cancer survivors, causing serious disruption in quality of life. Behavioral interventions incorporating physical activity or relaxation/stress management have demonstrated beneficial effects on cancer-related fatigue, although research in cancer survivors is limited. Mind-body interventions such as yoga are extremely popular among cancer patients and offer a promising alternative to traditional treatments. Research is needed to establish the feasibility and efficacy of these interventions in cancer populations, particularly those who are experiencing problems with fatigue.
- Conditions
- Breast Cancer, Fatigue
- Being tested
- Iyengar Yoga, Wellness Seminar Series
- Keywords
- Breast Cancer, Fatigue, Proinflammatory Cytokines, Physical functioning, Quality of life
- Medical subject headings
- Breast Neoplasms, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iyengar YogaOther
Also called Yoga
The poses and breathing techniques to be used in this study are based on sequences developed by B.K.S. Iyengar for breast cancer survivors who suffer from fatigue. Women will start with simple versions of the poses and progress to more advanced versions over the course of the intervention.
Wellness Seminar SeriesOther
Also called Health education
The Wellness Seminar Series consists of lectures on key topics, followed by group discussion. This series will focus entirely on cancer survivorship, including sessions on quality of life, side effects of cancer treatment, stress, nutrition and psychosocial issues.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Yoga Receives: Other: Iyengar Yoga |
| 2 | Active comparator | A Wellness Seminar series Receives: Other: Wellness Seminar Series |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue
Measured: Measured at baseline, after the 12 week intervention and at 3 months post-intervention
Secondary outcomes (1)
Secondary outcomes include depressed mood, sleep disturbance, pain, quality of life, and proinflammatory cytokine activity
Measured: Measured at baseline, after the 12 week intervention and at 3 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2008 (estimated)
- Study startJun 2008
- Primary completionOct 2010
- Study completionDec 2010
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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Principal investigator, Bower, Julienne, National Center for Complementary and Integrative Health (NCCIH)
- Investigators
- Julienne E Bower, Ph.D., Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00727662
- Sponsor's protocol ID
- U01AT003682
- Status last verified
- Apr 2015
- First submitted
- 31 Jul 2008
- Last updated
- 14 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bower JE, Woolery A, Sternlieb B, Garet D. Yoga for cancer patients and survivors. Cancer Control. 2005 Jul;12(3):165-71. doi: 10.1177/107327480501200304.
PubMed 16062164
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iyengar Yoga for Breast Cancer Survivors With Persistent Fatigue
- ClinicalTrials.gov ID
- NCT00727662
- Acronym / sponsor ID
- U01AT003682
- Conditions
- Breast Cancer, Fatigue
- Keywords
- Breast Cancer, Fatigue, Proinflammatory Cytokines, Physical functioning, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Study start
- Jun 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 4 Aug 2008 (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 randomized controlled trial will compare the effectiveness of an Iyengar Yoga intervention to a Wellness Seminar health education lecture series, for improvements in energy, mood and biological functioning in breast cancer survivors with persistent, post-treatment fatigue. It is anticipated that the Iyengar Yoga intervention will be feasible and acceptable to breast cancer survivors with minimal side effects and that the Yoga intervention will be effective in improving fatigue and physical performance.
Detailed description
Fatigue is the most common and distressing side effect of cancer treatment and persists beyond successful treatment completion in approximately 30% of breast cancer survivors, causing serious disruption in quality of life. Behavioral interventions incorporating physical activity or relaxation/stress management have demonstrated beneficial effects on cancer-related fatigue, although research in cancer survivors is limited. Mind-body interventions such as yoga are extremely popular among cancer patients and offer a promising alternative to traditional treatments. Research is needed to establish the feasibility and efficacy of these interventions in cancer populations, particularly those who are experiencing problems with fatigue.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Iyengar YogaYoga |
| 2 | Active comparator | Other: Wellness Seminar SeriesA Wellness Seminar series |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosed with early, resectable breast cancer (Stage I or II)
- Completed treatment with surgery, radiation, and/or chemotherapy between 6 months and 5 years previously
- No other cancer in last 5 years, including breast cancer recurrence
- Postmenopausal women
- Age 40 - 65
Key exclusion criteria (9 listed)
- Evidence that fatigue is directly related to a medical or psychiatric disorder (e.g., untreated hypothyroidism, diabetes, anemia (defined as hematocrit < 24), chronic fatigue syndrome, current major depression, insomnia, sleep apnea, restless leg syndrome)
- Evidence that fatigue is related to other non-cancer related factors (e.g., shift work, recent change in activity or schedule)
- Physical problems or conditions that could make yoga unsafe (e.g., serious neck injuries, unstable joints; also severe cachexia, dizziness, bone pain, severe nausea, etc)
- Regular use of medications and/or behavioral therapies that would confound evaluation of IY, including regular participation in yoga classes
- Presence of medical conditions that involve the immune system and would confound immune evaluation (e.g., autoimmune disorder, inflammatory disease)
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 |
|---|---|---|
| Iyengar YogaAlso: YogaThe poses and breathing techniques to be used in this study are based on sequences developed by B.K.S. Iyengar for breast cancer survivors who suffer from fatigue. Women will start with simple versions of the poses and progress to more advanced versions over the course of the intervention. | Other | 1 |
| Wellness Seminar SeriesAlso: Health educationThe Wellness Seminar Series consists of lectures on key topics, followed by group discussion. This series will focus entirely on cancer survivorship, including sessions on quality of life, side effects of cancer treatment, stress, nutrition and psychosocial issues. | Other | 2 |
Primary outcome
Fatigue
Time frame: Measured at baseline, after the 12 week intervention and at 3 months post-intervention
1 secondary outcome
Secondary outcomes include depressed mood, sleep disturbance, pain, quality of life, and proinflammatory cytokine activity
Time frame: Measured at baseline, after the 12 week intervention and at 3 months post-intervention
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 14 Apr 2015.
- Background: PubMed 16062164Bower JE, Woolery A, Sternlieb B, Garet D. Yoga for cancer patients and survivors. Cancer Control. 2005 Jul;12(3):165-71. doi: 10.1177/107327480501200304.
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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.
Julienne E Bower, Ph.D. principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iyengar Yoga and Wellness Seminar Series in people with Breast Cancer and Fatigue, run by National Center for Complementary and Integrative Health (NCCIH) 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 6 inclusion and 9 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 14 Apr 2015. 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?
Fatigue (time frame: Measured at baseline, after the 12 week intervention and at 3 months post-intervention). 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 NCT00727662, 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 14 Apr 2015.