Breast CancerNCT00982748
Yoga Breathing for Fatigue in Patients Undergoing Chemotherapy
A study testing Pranayama (Yoga Breathing) Techniques in people with Breast Cancer, run by University of California, San Francisco at 1 site in United States.
Trial summary
The purpose of this study is to determine the feasibility and efficacy of yoga breathing techniques to manage fatigue and other cancer-related side effects, in cancer patients undergoing chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Pranayama (Yoga Breathing) Techniques
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Dec 2009
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A diagnosis of cancer that requires at least 2 further cycles of chemotherapy on an every 14, 21, or 28 day schedule
- A score of at least 4/10 on a 0-10 (0-none, 10-most) visual analog scale for fatigue at the time of enrollment
- Able to read, write and understand English
- Karnofsky Performance Status greater than 60
- Ability to give informed consent
Who cannot join
- Severe COPD
- Receiving chronic oxygen therapy
- Congestive heart failure: NYHA class 3 or greater
- Transfusion dependent anemia
- Uncontrolled thyroid disease
- Advance kidney disease requiring dialysis
Show all 9Show fewer
- Advance liver disease
- More than three previous chemotherapy regimens
- Current, ongoing yoga breathing practice
Trial locations and contacts
1 site in 1 country.
United States1 site
Osher Center for Integrative Medicine, UCSF
San Francisco, California, 94115
About this study
Official title: Effects of Pranayama on Fatigue Among Patients Undergoing Chemotherapy
The purpose of this study is to determine the feasibility and efficacy of yoga breathing techniques to manage fatigue and other cancer-related side effects, in cancer patients undergoing chemotherapy.
Read the detailed description
Fatigue is the most common complaint among cancer patients. This pilot study will evaluate the effects of pranayama (ancient yoga breathing techniques) on fatigue and quality of life among 30 patients undergoing chemotherapy, on an every 2, 3, or 4 week schedule, with a fatigue score of at least 4 on a scale of 0 (none) to 10 (most). Patients will be randomized to either pranayama or wait-list control. The pranayama group will learn and practice 3 breathing techniques on a daily basis. The study period will occur during 2 consecutive cycles of chemotherapy (cycle A and Cycle B), and the wait-list control patients will crossover to the treatment arm at the beginning of his/her Cycle B. Fatigue will be measured using the revised Piper Fatigue Scale along with quality of life measures. These study measures will be conducted at baseline, at the end of cycle A, and at the end of cycle B. We hypothesize that pranayama will improve clinical symptoms of fatigue and quality of life among patients undergoing chemotherapy.
- Conditions
- Breast Cancer
- Being tested
- Pranayama (Yoga Breathing) Techniques
- Keywords
- Fatigue, Chemotherapy, Yoga, Breathing, Cancer, Anxiety, Pranayama, Stress, Fatigue-associated symptoms in chemotherapy patients, Quality of life in chemotherapy patients
- Medical subject headings
- Breast Neoplasms, Fatigue, Respiratory Aspiration, Neoplasms, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pranayama (Yoga Breathing) TechniquesBehavioural
1-hour long yoga breathing classes, taught once per week for 2-8 consecutive weeks. Dose (Number of classes) administered is dependent on randomization arm and individuals' chemotherapy cycle length.
| Study group | Role | What they receive |
|---|---|---|
| Group B | Active comparator | Study participants in this arm attend yoga breathing classes once per week over the span of one chemotherapy cycle. Receives: Behavioral: Pranayama (Yoga Breathing) Techniques |
| Group A | Experimental | Participants in this study arm attend weekly yoga breathing classes during two consecutive cycles of chemotherapy Receives: Behavioral: Pranayama (Yoga Breathing) Techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
Feasibility will be evaluated based on recruitment, retention, completion of study classes and home practice, and completion of study measures
Measured: Baseline and second cycle of chemotherapy
Secondary outcomes (1)
Cancer associated symptoms and quality of life
fatigue, sleep, stress, anxiety and depression quality of life
Measured: baseline and final cycle of chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2009 (estimated)
- Study startOct 2008
- Primary completionDec 2009
- Study completionDec 2009
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 University of California, San FranciscoThe 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anand Dhruva, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00982748
- Sponsor's protocol ID
- 08803
- Other IDs
- Mt.Zion Healthfund 20070658
- Status last verified
- Aug 2011
- First submitted
- 18 Sep 2009
- Last updated
- 25 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dhruva A, Miaskowski C, Abrams D, Acree M, Cooper B, Goodman S, Hecht FM. Yoga breathing for cancer chemotherapy-associated symptoms and quality of life: results of a pilot randomized controlled trial. J Altern Complement Med. 2012 May;18(5):473-9. doi: 10.1089/acm.2011.0555. Epub 2012 Apr 23.
PubMed 22525009
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pranayama on Fatigue Among Patients Undergoing Chemotherapy
- ClinicalTrials.gov ID
- NCT00982748
- Acronym / sponsor ID
- 08803
- Conditions
- Breast Cancer
- Keywords
- Fatigue, Chemotherapy, Yoga, Breathing, Cancer, Anxiety, Pranayama, Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 23 Sep 2009 (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 this study is to determine the feasibility and efficacy of yoga breathing techniques to manage fatigue and other cancer-related side effects, in cancer patients undergoing chemotherapy.
Detailed description
Fatigue is the most common complaint among cancer patients. This pilot study will evaluate the effects of pranayama (ancient yoga breathing techniques) on fatigue and quality of life among 30 patients undergoing chemotherapy, on an every 2, 3, or 4 week schedule, with a fatigue score of at least 4 on a scale of 0 (none) to 10 (most). Patients will be randomized to either pranayama or wait-list control. The pranayama group will learn and practice 3 breathing techniques on a daily basis. The study period will occur during 2 consecutive cycles of chemotherapy (cycle A and Cycle B), and the wait-list control patients will crossover to the treatment arm at the beginning of his/her Cycle B. Fatigue will be measured using the revised Piper Fatigue Scale along with quality of life measures. These study measures will be conducted at baseline, at the end of cycle A, and at the end of cycle B. We hypothesize that pranayama will improve clinical symptoms of fatigue and quality of life among patients undergoing chemotherapy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group B | Active comparator | Behavioral: Pranayama (Yoga Breathing) TechniquesStudy participants in this arm attend yoga breathing classes once per week over the span of one chemotherapy cycle. |
| Group A | Experimental | Behavioral: Pranayama (Yoga Breathing) TechniquesParticipants in this study arm attend weekly yoga breathing classes during two consecutive cycles of chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- A diagnosis of cancer that requires at least 2 further cycles of chemotherapy on an every 14, 21, or 28 day schedule
- A score of at least 4/10 on a 0-10 (0-none, 10-most) visual analog scale for fatigue at the time of enrollment
- Able to read, write and understand English
- Karnofsky Performance Status greater than 60
- Ability to give informed consent
Key exclusion criteria (9 listed)
- Severe COPD
- Receiving chronic oxygen therapy
- Congestive heart failure: NYHA class 3 or greater
- Transfusion dependent anemia
- Uncontrolled thyroid 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 |
|---|---|---|
| Pranayama (Yoga Breathing) Techniques1-hour long yoga breathing classes, taught once per week for 2-8 consecutive weeks. Dose (Number of classes) administered is dependent on randomization arm and individuals' chemotherapy cycle length. | Behavioural | Group A, Group B |
Primary outcome
Feasibility
Time frame: Baseline and second cycle of chemotherapy
Feasibility will be evaluated based on recruitment, retention, completion of study classes and home practice, and completion of study measures
1 secondary outcome
Cancer associated symptoms and quality of life
Time frame: baseline and final cycle of chemotherapy
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 25 Aug 2011.
- Derived from this study: PubMed 22525009Dhruva A, Miaskowski C, Abrams D, Acree M, Cooper B, Goodman S, Hecht FM. Yoga breathing for cancer chemotherapy-associated symptoms and quality of life: results of a pilot randomized controlled trial. J Altern Complement Med. 2012 May;18(5):473-9. doi: 10.1089/acm.2011.0555. Epub 2012 Apr 23.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pranayama (Yoga Breathing) Techniques in people with Breast Cancer, run by University of California, San Francisco 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 5 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 25 Aug 2011. 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?
Feasibility (time frame: Baseline and second cycle of chemotherapy). 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 NCT00982748, 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 25 Aug 2011.