Breast NeoplasmsIFaBNCT01686737
Iyengar Yoga for Chemotherapy-induced Fatigue in Breast Cancer Patients
A study testing Iyengar Yoga and Walking in people with Breast Neoplasms and Fatigue, run by Universität Duisburg-Essen at 2 sites in Germany.
Trial summary
Breast cancer is the most frequent cancer in women and is associated with profound restrictions of health-related quality of life and psychosocial health. More than three-quarters of women with breast cancer suffer from fatigue during cancer treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms, Fatigue
- What is being tested?
- Iyengar Yoga and Walking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesGermany
- Study dates
- Nov 2012to Jul 2014
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- non-metastatic invasive breast cancer
- currently receiving adjuvant chemotherapy
- moderate to severe chemotherapy-induced fatigue
- physical and cognitive capacity to participate in yoga or walking
Who cannot join
- diagnosed and pharmacologically treated psychiatric disorder except depressive adaptation disorder as a reaction to cancer diagnosis
- ECOG status > 1
- prior malignancy with a disease-free survival < 10 years except curatively treated basalioma of the skin and carcinoma in situ of the cervix
- prior ductal carcinoma in situ (DCIS) ot the breast
- pregnancy or breastfeeding
- regular practice of yoga or walking during the past 12 months
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Brustzentrum Köln-Hohenlind, St. Elisabeth-Krankenhaus Köln-Hohenlind
Cologne, 50935
Klinik für Senologie / Brustzentrum, Kliniken Essen-Mitte
Essen, 45136
About this study
Breast cancer is the most frequent cancer in women and is associated with profound restrictions of health-related quality of life and psychosocial health. More than three-quarters of women with breast cancer suffer from fatigue during cancer treatment. While exercise interventions can improve fatigue in breast cancer patients, many patients request complementary treatment approaches. Therefore, this study investigates the effects of yoga in women with breast cancer compared to aerobic exercise and usual care.
It is hypothesized that yoga is more effective than usual care and equally effective as aerobic exercise.
- Conditions
- Breast Neoplasms, Fatigue
- Being tested
- Iyengar Yoga, Walking
- 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 YogaBehavioural
- 12 weeks of Iyengar yoga
- 2 weekly sessions of 60 minutes
WalkingBehavioural
- 12 weeks of walking
- 2 weekly sessions of 60 minutes
| Study group | Role | What they receive |
|---|---|---|
| Yoga | Experimental | Iyengar Yoga
* 12 weeks of Iyengar yoga
* 2 weekly sessions of 60 minutes Receives: Behavioral: Iyengar Yoga |
| Aerobic exercise | Active comparator | Walking
* 12 weeks of walking
* 2 weekly sessions of 60 minutes Receives: Behavioral: Walking |
| Usual Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue
Multidimensional Fatigue Inventory
Measured: Week 12
Secondary outcomes (7)
Fatigue
Multidimensional Fatigue Inventory
Measured: Week 36
Health-related quality of life
Functional Assessment of Cancer Therapy - Breast
Measured: Week 12, week 36
Depression and anxiety
Hospital Anxiety and Depression Scale
Measured: Week 12, week 36
Sleep quality
Pittsburgh Sleep Quality Index
Measured: Week 12, week 36
Perceived Stress
- Perceived Stress Scale
- Impact of Event Scale
Measured: Week 12, week 36
Salivary Cortisol
Cortisol awakening response
Measured: Week 12, week 36
Safety
Adverse events
Measured: Week 0-36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2012 (estimated)
- Study startNov 2012
- Primary completionJan 2014 (estimated)
- Study completionJul 2014 (estimated)
Why it stopped: Recruitment problems
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universität Duisburg-Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Holger Cramer, Universität Duisburg-Essen
- Investigators
- Holger Cramer, PhD, Principal investigator, University of Duisburg-Essen, Chair of Complementary and Integrative MedicineGustav J. Dobos, MD, Study director, University of Duisburg-Essen, Chair of Complementary and Integrative Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01686737
- Sponsor's protocol ID
- 2012210
- Acronym
- IFaB
- Status last verified
- Feb 2013
- First submitted
- 12 Sep 2012
- Last updated
- 5 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iyengar Yoga for Chemotherapy-induced Fatigue in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT01686737
- Acronym / sponsor ID
- IFaB / 2012210
- Conditions
- Breast Neoplasms, Fatigue
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Recruitment problems
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Universität Duisburg-EssenUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 18 Sep 2012 (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.
Breast cancer is the most frequent cancer in women and is associated with profound restrictions of health-related quality of life and psychosocial health. More than three-quarters of women with breast cancer suffer from fatigue during cancer treatment. While exercise interventions can improve fatigue in breast cancer patients, many patients request complementary treatment approaches. Therefore, this study investigates the effects of yoga in women with breast cancer compared to aerobic exercise and usual care.
It is hypothesized that yoga is more effective than usual care and equally effective as aerobic exercise.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Yoga | Experimental | Behavioral: Iyengar YogaIyengar Yoga * 12 weeks of Iyengar yoga * 2 weekly sessions of 60 minutes |
| Aerobic exercise | Active comparator | Behavioral: WalkingWalking * 12 weeks of walking * 2 weekly sessions of 60 minutes |
| Usual Care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- non-metastatic invasive breast cancer
- currently receiving adjuvant chemotherapy
- moderate to severe chemotherapy-induced fatigue
- physical and cognitive capacity to participate in yoga or walking
Key exclusion criteria (6 listed)
- diagnosed and pharmacologically treated psychiatric disorder except depressive adaptation disorder as a reaction to cancer diagnosis
- ECOG status > 1
- prior malignancy with a disease-free survival < 10 years except curatively treated basalioma of the skin and carcinoma in situ of the cervix
- prior ductal carcinoma in situ (DCIS) ot the breast
- pregnancy or breastfeeding
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 Yoga* 12 weeks of Iyengar yoga * 2 weekly sessions of 60 minutes | Behavioural | Yoga |
| Walking* 12 weeks of walking * 2 weekly sessions of 60 minutes | Behavioural | Aerobic exercise |
Primary outcome
Fatigue
Time frame: Week 12
Multidimensional Fatigue Inventory
7 secondary outcomes
Fatigue
Time frame: Week 36
Health-related quality of life
Time frame: Week 12, week 36
Depression and anxiety
Time frame: Week 12, week 36
Sleep quality
Time frame: Week 12, week 36
Perceived Stress
Time frame: Week 12, week 36
Salivary Cortisol
Time frame: Week 12, week 36
Safety
Time frame: Week 0-36
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2013.
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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.
Holger Cramer, PhD principal investigator
University of Duisburg-Essen, Chair of Complementary and Integrative Medicine
Gustav J. Dobos, MD study director
University of Duisburg-Essen, Chair of Complementary and Integrative Medicine
2 sites 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 Walking in people with Breast Neoplasms and Fatigue, run by Universität Duisburg-Essen at 2 sites in Germany.
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 4 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: withdrawn, as of the sponsor's last update on 5 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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 was withdrawn before enrolling participants, so there are no results.
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: Week 12). 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 5 Feb 2013.