Breast CancerNCT00486525

Hatha Yoga in Improving Physical Activity, Inflammation, Fatigue, and Distress in Breast Cancer Survivors

A study testing Yoga Therapy in people with Breast Cancer and Depression, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

RATIONALE: Yoga may improve inflammation, fatigue, and depression in female breast cancer survivors. PURPOSE: This randomized clinical trial is studying how well Hatha yoga works in improving physical activity, inflammation, fatigue, and distress in female breast cancer survivors. Read more about this study

Who is it for?: Ages 21 years and older, women only
Conditions the study is for: Breast Cancer, Depression, Fatigue
What is being tested?: Yoga Therapy
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 200 participants
Where: 1 siteUnited States
Study dates: Aug 2007to Mar 2013
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Hemoglobin ≥ 10 g/dL (patients with a hemoglobin of < 10 g/dL may be retested in 6 weeks after treatment of anemia and allowed to participate in study if blood counts recovered)
Physically able to fully participate in yoga intervention

Who cannot join

Inability to comfortably get up and down from the floor 2-3 times in a session
Breathing problems requiring use of oxygen
Problems walking without a cane or walker assistance
Prior knee or hip replacement with limited movement in the joint
Inability to comfortably lie on the stomach
Alcohol, or drug abuse

Show all 20Show fewer

Diagnosis of any of the following conditions:
Diabetes
Chronic obstructive pulmonary disease
Uncontrolled hypertension
Evidence of liver or kidney failure
Symptomatic ischemic heart disease
Significant visual or auditory problems
Mental disorder or cognitive impairment
Notable serious cardiovascular history (e.g., prior life-threatening abnormal heart rhythms)
Other medical conditions involving the immune system such as autoimmune and/or inflammatory diseases including rheumatoid arthritis and ulcerative colitis
History of breast or any other cancer, except basal or squamous cell skin cancer
PRIOR CONCURRENT THERAPY:
See Disease Characteristics
No regular use of medications with major immunological consequences (e.g., steroids)

Trial locations and contacts

1 site in 1 country.

United States1 site

Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210-1240

Other trials in United States

About this study

Official title: Breast Cancer Survivors: Physical Activity, Inflammation, Fatigue, and Distress

RATIONALE: Yoga may improve inflammation, fatigue, and depression in female breast cancer survivors.

PURPOSE: This randomized clinical trial is studying how well Hatha yoga works in improving physical activity, inflammation, fatigue, and distress in female breast cancer survivors.

Read the detailed description

OBJECTIVES:

Primary

To determine if the yoga intervention will decrease inflammation, fatigue, and depressive symptoms relative to the waiting-list controls in women who are stage 0-IIIa breast cancer survivors.

OUTLINE: Patients are stratified according to stage of cancer (stage 0 vs stage I vs stage II and stage IIIA) and prior radiation therapy (yes vs no). Patients are randomized to 1 of 2 intervention arms.

Arm I (waiting-list control): Patients are encouraged to perform usual activities, but asked to refrain from any yoga practice or other related activities. After a six-month observation period, patients undergo yoga intervention as described in arm II .
Arm II (yoga intervention): Patients participate in a Hatha yoga intervention session comprising body postures and breath control techniques for 1.5 hours twice a week for 12 weeks. Patients are encouraged to practice Hatha yoga at home. Patients complete daily diaries on home Hatha yoga practices and submit them at each session.

Conditions: Breast Cancer, Depression, Fatigue, Pain
Being tested: Yoga Therapy
Keywords: fatigue, depression, pain, cancer survivor, stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer, breast cancer in situ
Medical subject headings: Breast Neoplasms, Depression, Fatigue, Pain, Breast Carcinoma In Situ

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Yoga TherapyProcedure or surgery
Also called Yoga
Patients will undergo yoga therapy

Study groups in NCT00486525
Study group	Role	What they receive
Arm I: Yoga Therapy	Experimental	Patients participate in a Hatha yoga session over 90 minutes twice weekly for 12 weeks. Patients are also encouraged to practice yoga at home using the appropriate DVD/video segments for the month. Receives: Procedure: Yoga Therapy
Arm II: Wait-List	No intervention	Wait-listed women were told to continue performing their usual activities, and to refrain from beginning any yoga practice. After their final assessment they were offered the yoga classes.

What is being measured

The primary outcome is the main question the study is designed to answer.

Stimulated ln (TNF-a)
log-transformed Lipopolysaccharide (LPS) stimulated Tumor Necrosis Factor-alpha (TNF-alpha)
Measured: Immediately post-treatment and 3 months post-treatment
Stimulated ln (IL-6)
log-transformed Lipopolysaccharide (LPS) stimulated Interleukin-6 (IL-6)
Measured: Immediately post-treatment and 3 months post-treatment
Stimulated ln (IL-1b)
log-transformed Lipopolysaccharide (LPS) stimulated Interleukin-1 beta (IL-1b)
Measured: Immediately post-treatment and 3 months post-treatment
MFSI-SF Fatigue
The 30-item Multidimensional Fatigue Symptom Inventory-Short form (MFSI-SF) assesses behavioral, cognitive, physical, and affective expressions of fatigue.
Items are rated on a 5-point scale indicating how true each statement was for the respondent during the last week (0=not at all; 4=extremely). The total score represents the sum of the subscales measuring general, physical, emotional, and mental fatigue, minus the vigor scale, providing a possible range of scores from -24 to 96, with higher scores indicating greater fatigue.
Measured: Immediately post-treatment and 3 months post-treatment
Vitality, SF-36
The SF-36's (RAND Health Survey) energy/fatigue (vitality) scale focuses on the frequency of feelings of fatigue over the last month.
Standardized scores on the RAND SF-36 vigor/vitality scale range from 0-100, with higher scores indicating less fatigue.
Measured: Immediately post-treatment and 3 months post-treatment
CES-D
The Center for Epidemiological Studies Depression Scale (CES-D) is a self-report scale designed to measure current symptoms of depression rated on a four-point likert scale.
Scores range from 0-60, with higher scores indicating a higher frequency of depressive symptoms.
Measured: Immediately post-treatment and 3 months post-treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2007Mar 2013

First posted14 Jun 2007 (estimated)
Study startAug 2007
Primary completionNov 2012
Study completionMar 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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 Ohio State University Comprehensive 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: Single blind
Who is masked: Outcomes assessor
Enrolment: 200 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00486525
Sponsor's protocol ID: OSU-06137
Other IDs: NCI-2012-00564, R01CA126857
Status last verified: Apr 2014
First submitted: 13 Jun 2007
Last updated: 5 May 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Kiecolt-Glaser JK, Bennett JM, Andridge R, Peng J, Shapiro CL, Malarkey WB, Emery CF, Layman R, Mrozek EE, Glaser R. Yoga's impact on inflammation, mood, and fatigue in breast cancer survivors: a randomized controlled trial. J Clin Oncol. 2014 Apr 1;32(10):1040-9. doi: 10.1200/JCO.2013.51.8860. Epub 2014 Jan 27.
PubMed 24470004

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Breast Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 5 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Breast Cancer Survivors: Physical Activity, Inflammation, Fatigue, and Distress
ClinicalTrials.gov ID: NCT00486525
Acronym / sponsor ID: OSU-06137
Conditions: Breast Cancer, Depression, Fatigue, Pain
Keywords: fatigue, depression, pain, cancer survivor, stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer
Study type: Interventional
Recruitment status: Completed
Enrolment: 200 participants (actual)
Lead sponsor: Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: Aug 2007
Primary completion: Nov 2012 (actual)
Study completion: Mar 2013 (actual)
First posted: 14 Jun 2007 (estimated)
Results: Posted 10 Apr 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

RATIONALE: Yoga may improve inflammation, fatigue, and depression in female breast cancer survivors.

PURPOSE: This randomized clinical trial is studying how well Hatha yoga works in improving physical activity, inflammation, fatigue, and distress in female breast cancer survivors.

Detailed description

OBJECTIVES:

Primary

To determine if the yoga intervention will decrease inflammation, fatigue, and depressive symptoms relative to the waiting-list controls in women who are stage 0-IIIa breast cancer survivors.

Arm I (waiting-list control): Patients are encouraged to perform usual activities, but asked to refrain from any yoga practice or other related activities. After a six-month observation period, patients undergo yoga intervention as described in arm II .
Arm II (yoga intervention): Patients participate in a Hatha yoga intervention session comprising body postures and breath control techniques for 1.5 hours twice a week for 12 weeks. Patients are encouraged to practice Hatha yoga at home. Patients complete daily diaries on home Hatha yoga practices and submit them at each session.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Arm I: Yoga Therapy	Experimental	Procedure: Yoga TherapyPatients participate in a Hatha yoga session over 90 minutes twice weekly for 12 weeks. Patients are also encouraged to practice yoga at home using the appropriate DVD/video segments for the month.
Arm II: Wait-List	No intervention	–Wait-listed women were told to continue performing their usual activities, and to refrain from beginning any yoga practice. After their final assessment they were offered the yoga classes.

Who may qualify

Ages: 21 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Hemoglobin ≥ 10 g/dL (patients with a hemoglobin of < 10 g/dL may be retested in 6 weeks after treatment of anemia and allowed to participate in study if blood counts recovered)
Physically able to fully participate in yoga intervention

Key exclusion criteria (20 listed)

Inability to comfortably get up and down from the floor 2-3 times in a session
Breathing problems requiring use of oxygen
Problems walking without a cane or walker assistance
Prior knee or hip replacement with limited movement in the joint
Inability to comfortably lie on the stomach

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 TherapyAlso: YogaPatients will undergo yoga therapy	Procedure or surgery	Arm I: Yoga Therapy

Primary outcome

Stimulated ln (TNF-a)
Time frame: Immediately post-treatment and 3 months post-treatment
log-transformed Lipopolysaccharide (LPS) stimulated Tumor Necrosis Factor-alpha (TNF-alpha)
Stimulated ln (IL-6)
Time frame: Immediately post-treatment and 3 months post-treatment
log-transformed Lipopolysaccharide (LPS) stimulated Interleukin-6 (IL-6)
Stimulated ln (IL-1b)
Time frame: Immediately post-treatment and 3 months post-treatment
log-transformed Lipopolysaccharide (LPS) stimulated Interleukin-1 beta (IL-1b)
MFSI-SF Fatigue
Time frame: Immediately post-treatment and 3 months post-treatment
The 30-item Multidimensional Fatigue Symptom Inventory-Short form (MFSI-SF) assesses behavioral, cognitive, physical, and affective expressions of fatigue. Items are rated on a 5-point scale indicating how true each statement was for the respondent during the last week (0=not at all; 4=extremely). The total score represents the sum of the subscales measuring general, physical, emotional, and mental fatigue, minus the vigor scale, providing a possible range of scores from -24 to 96, with higher scores indicating greater fatigue.
Vitality, SF-36
Time frame: Immediately post-treatment and 3 months post-treatment
The SF-36's (RAND Health Survey) energy/fatigue (vitality) scale focuses on the frequency of feelings of fatigue over the last month. Standardized scores on the RAND SF-36 vigor/vitality scale range from 0-100, with higher scores indicating less fatigue.
CES-D
Time frame: Immediately post-treatment and 3 months post-treatment
The Center for Epidemiological Studies Depression Scale (CES-D) is a self-report scale designed to measure current symptoms of depression rated on a four-point likert scale. Scores range from 0-60, with higher scores indicating a higher frequency of depressive symptoms.

Results and safety

Results posted to the registry on 10 Apr 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm I: Yoga Therapy	100	94
Arm II: Wait-List	100	87

Primary outcome: Stimulated ln (TNF-a)

Time frame: Immediately post-treatment and 3 months post-treatment. Least squares mean (Standard Error). Unit: ln (pg/mL)

Measure	Arm I: Yoga Therapy n = 92	Arm II: Wait-List n = 84
Immediately post-treatment	8.31 (0.041)	8.39 (0.040)
3 months post-treatment	8.31 (0.042)	8.44 (0.043)

Arm I: Yoga Therapy vs Arm II: Wait-List: Mean Difference (Final Values): -0.075 (95% CI -0.19 to 0.039), p = 0.20, Mixed Models Analysis
Arm I: Yoga Therapy vs Arm II: Wait-List: Mean Difference (Final Values): -0.13 (95% CI -0.25 to -0.015), p = 0.027, Mixed Models Analysis
Arm I: Yoga Therapy vs Arm II: Wait-List: Slope: -0.021 (95% CI -0.060 to 0.018), p = 0.28, Mixed Models Analysis

Population analysed: Any subjects who do not have any measurements post-baseline are excluded from analyses.

Primary outcome: Stimulated ln (IL-6)

Time frame: Immediately post-treatment and 3 months post-treatment. Least squares mean (Standard Error). Unit: ln (pg/mL)

Measure	Arm I: Yoga Therapy n = 92	Arm II: Wait-List n = 84
Immediately post-treatment	9.68 (0.043)	9.76 (0.044)
3 months post-treatment	9.69 (0.044)	9.85 (0.047)

Arm I: Yoga Therapy vs Arm II: Wait-List: Mean Difference (Final Values): -0.079 (95% CI -0.2 to -0.042), p = 0.2, Mixed Models Analysis
Arm I: Yoga Therapy vs Arm II: Wait-List: Mean Difference (Final Values): -0.16 (95% CI -0.28 to -0.031), p = 0.015, Mixed Models Analysis
Arm I: Yoga Therapy vs Arm II: Wait-List: Slope: -0.022 (95% CI -0.063 to 0.019), p = 0.3, Mixed Models Analysis

Population analysed: Any subjects who do not have any measurements post-baseline are excluded from analyses.

Primary outcome: Stimulated ln (IL-1b)

Time frame: Immediately post-treatment and 3 months post-treatment. Least squares mean (Standard Error). Unit: ln (pg/mL)

Measure	Arm I: Yoga Therapy n = 92	Arm II: Wait-List n = 84
Immediately post-treatment	8.31 (0.077)	8.42 (0.071)
3 months post-treatment	8.32 (0.079)	8.55 (0.074)

Arm I: Yoga Therapy vs Arm II: Wait-List: Mean Difference (Final Values): -0.10 (95% CI -0.31 to 0.11), p = 0.33, Mixed Models Analysis
Arm I: Yoga Therapy vs Arm II: Wait-List: Mean Difference (Final Values): -0.23 (95% CI -0.44 to -0.014), p = 0.037, Mixed Models Analysis
Arm I: Yoga Therapy vs Arm II: Wait-List: Slope: -0.034 (95% CI -0.10 to 0.035), p = 0.33, Mixed Models Analysis

Population analysed: Any subjects who do not have any measurements post-baseline are excluded from analyses.

Primary outcome: MFSI-SF Fatigue

Time frame: Immediately post-treatment and 3 months post-treatment. Least squares mean (Standard Error). Unit: units on a scale

Measure	Arm I: Yoga Therapy n = 96	Arm II: Wait-List n = 90
Immediately post-treatment	6.1 (1.7)	10.3 (1.4)
3 months post-treatment	5.4 (1.7)	12.4 (1.4)

Arm I: Yoga Therapy vs Arm II: Wait-List: Mean Difference (Final Values): -4.2 (95% CI -8.5 to 0.15), p = 0.058, Mixed Models Analysis
Arm I: Yoga Therapy vs Arm II: Wait-List: Mean Difference (Final Values): -7.0 (95% CI -11.4 to -2.7), p = 0.002, Mixed Models Analysis
Arm I: Yoga Therapy vs Arm II: Wait-List: Slope: -1.7 (95% CI -3.1 to -0.28), p = 0.019, Mixed Models Analysis

Population analysed: Any subjects who do not have any measurements post-baseline are excluded from analyses.

Adverse events

Time frame: Post-intervention. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm I: Yoga Therapy	0 of 100 (0%)	2 of 100 (2%)	Not reported
Arm II: Wait-List	0 of 100 (0%)	0 of 100 (0%)	Not reported

Limitations and caveats (from the sponsor): We did not compare yoga to an active control group; Fatigue and depressive symptoms were not used as part of the inclusion criteria. Accordingly, our data may underestimate yoga's potential benefit.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 24470004Kiecolt-Glaser JK, Bennett JM, Andridge R, Peng J, Shapiro CL, Malarkey WB, Emery CF, Layman R, Mrozek EE, Glaser R. Yoga's impact on inflammation, mood, and fatigue in breast cancer survivors: a randomized controlled trial. J Clin Oncol. 2014 Apr 1;32(10):1040-9. doi: 10.1200/JCO.2013.51.8860. Epub 2014 Jan 27.
The JameslineLink 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.

Janice Kiecolt-Glaser, PhD study chair

Ohio State University Comprehensive 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 Therapy in people with Breast Cancer and Depression, run by Ohio State University Comprehensive 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 2 inclusion and 20 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 5 May 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 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?

Yes. Results are posted in the registry (first posted 10 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Stimulated ln (TNF-a) (time frame: Immediately post-treatment and 3 months post-treatment). The study lists 6 primary outcomes in all. 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 NCT00486525, 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 5 May 2014.