Breast CancerPhase 2NCT01387841
Effect of Yoga in Reducing Chemotherapy Induced Nausea and Vomiting
A Phase 2 study testing yoga and Jacobsons PMRT group in people with Breast Cancer and Malignant Female Reproductive System Neoplasm, run by Bharath Charitable Cancer Hospital and Institute at 1 site in India.
Trial summary
This randomized controlled three arm study compares the effects of a yoga intervention with jacobsons progressive muscle relaxation training and only standard of care in chemotherapy naive cancer patients. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Malignant Female Reproductive System Neoplasm, Lymphomas
- What is being tested?
- yoga and Jacobsons PMRT group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIndia
- Study dates
- May 2010to Jan 2013
- Phase
- Phase 2
- 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 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with gynecologic malignancies (breast, ovary) and Lymphomas.
- Age between 30-70 years.
- Chemotherapy naïve.
- High school education.
Who cannot join
- Those with brain metastases
- Concurring medical condition likely to influence survival
- Uncontrolled diabetes and hypertension
- GI metastases, peritoneal fluid, uraemia
- Neurological disorders such as Parkinson's disease, myotonic dystrophy etc.
- GI obstruction and past H/o abdominal surgeries.
- Cognitive impairments.
- Regular participation in a behavioral intervention/yoga in the last six months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Yoga Versus Relaxation on Chemotherapy Induced Nausea and Vomiting (CINV) Outcomes Following Chemotherapy
- This randomized controlled three arm study compares the effects of a yoga intervention with jacobsons progressive muscle relaxation training and only standard of care in chemotherapy naive cancer patients.
- This study will also assess the neurophysiological correlates of nausea and vomiting and assess if effects of intervention on nausea and vomiting outcomes are mediated by changes in gastric motility (electrogastrogram) or stress arousal (cardiac autonomic function and sympathetic skin response) or self reported anxiety.
- Conditions
- Breast Cancer, Malignant Female Reproductive System Neoplasm, Lymphomas, Chemotherapy-induced Nausea and Vomiting
- Being tested
- yoga, Jacobsons PMRT group
- Keywords
- yoga, chemotherapy, nausea, vomiting
- Medical subject headings
- Breast Neoplasms, Lymphoma, Vomiting, Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
yogaBehavioural
Postures,relaxation techniques
Jacobsons PMRT groupBehavioural
Also called PMRT
jacobsons Progressive muscle relaxation training involving 16 muscle groups
| Study group | Role | What they receive |
|---|---|---|
| Yoga group | Experimental | Yoga intervention with standard antiemetic care Receives: Behavioral: yoga |
| PMRT/Jacobsons Relaxation training | Active comparator | 25 minutes of progressive muscle relaxation training will be given to this group with standard antiemetic care Receives: Behavioral: Jacobsons PMRT group |
| Standard antiemetic care | No intervention | Standard antiemetic care only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of yoga on chemotherapy induced nausea and vomiting
This study is to evaluate the effects of yoga intervention vs. Jacobsons progressive muscle relaxation vs. standard of care only on chemotherapy induced nausea and emesis (CINV) outcomes
Measured: 4 months (prior to every cycle of chemotherapy,for 4 cycles)
Secondary outcomes (1)
Quality of life after chemotherapy
Here we evaluate the effects of yoga intervention on secondary outcomes such as quality of life and anxiety states
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2011 (estimated)
- Study startMay 2010
- Primary completionDec 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bharath Charitable Cancer Hospital and Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Bangalore Institute of Oncology, CENTRAL COUNCIL FOR RESEARCH IN YOGA AND NATUROPATHY
- Responsible party
- Principal investigator, Dr Raghavendra Rao M, Bharath Charitable Cancer Hospital and Institute
- Investigators
- RAGHAVENDRA RAO, PHD, Principal investigator, HCG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01387841
- Sponsor's protocol ID
- Y010810
- Status last verified
- Jul 2013
- First submitted
- 1 Jul 2011
- Last updated
- 24 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Yoga Versus Relaxation on Chemotherapy Induced Nausea and Vomiting (CINV) Outcomes Following Chemotherapy
- ClinicalTrials.gov ID
- NCT01387841
- Acronym / sponsor ID
- Y010810
- Conditions
- Breast Cancer, Malignant Female Reproductive System Neoplasm, Lymphomas, Chemotherapy-induced Nausea and Vomiting
- Keywords
- yoga, chemotherapy, nausea, vomiting
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Bharath Charitable Cancer Hospital and InstituteUniversity, hospital or other
- Collaborators
- Bangalore Institute of Oncology, CENTRAL COUNCIL FOR RESEARCH IN YOGA AND NATUROPATHY
- Study start
- May 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 6 Jul 2011 (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 three arm study compares the effects of a yoga intervention with jacobsons progressive muscle relaxation training and only standard of care in chemotherapy naive cancer patients.
- This study will also assess the neurophysiological correlates of nausea and vomiting and assess if effects of intervention on nausea and vomiting outcomes are mediated by changes in gastric motility (electrogastrogram) or stress arousal (cardiac autonomic function and sympathetic skin response) or self reported anxiety.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Yoga group | Experimental | Behavioral: yogaYoga intervention with standard antiemetic care |
| PMRT/Jacobsons Relaxation training | Active comparator | Behavioral: Jacobsons PMRT group25 minutes of progressive muscle relaxation training will be given to this group with standard antiemetic care |
| Standard antiemetic care | No intervention | –Standard antiemetic care only |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with gynecologic malignancies (breast, ovary) and Lymphomas.
- Age between 30-70 years.
- Chemotherapy naïve.
- High school education.
Key exclusion criteria (8 listed)
- Those with brain metastases
- Concurring medical condition likely to influence survival
- Uncontrolled diabetes and hypertension
- GI metastases, peritoneal fluid, uraemia
- Neurological disorders such as Parkinson's disease, myotonic dystrophy etc.
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 |
|---|---|---|
| yogaPostures,relaxation techniques | Behavioural | Yoga group |
| Jacobsons PMRT groupAlso: PMRTjacobsons Progressive muscle relaxation training involving 16 muscle groups | Behavioural | PMRT/Jacobsons Relaxation training |
Primary outcome
Effect of yoga on chemotherapy induced nausea and vomiting
Time frame: 4 months (prior to every cycle of chemotherapy,for 4 cycles)
This study is to evaluate the effects of yoga intervention vs. Jacobsons progressive muscle relaxation vs. standard of care only on chemotherapy induced nausea and emesis (CINV) outcomes
1 secondary outcome
Quality of life after chemotherapy
Time frame: 4 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 24 Jul 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.
RAGHAVENDRA RAO, PHD principal investigator
HCG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing yoga and Jacobsons PMRT group in people with Breast Cancer and Malignant Female Reproductive System Neoplasm, run by Bharath Charitable Cancer Hospital and Institute at 1 site in India.
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 8 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 24 Jul 2013. 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 India. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Effect of yoga on chemotherapy induced nausea and vomiting (time frame: 4 months (prior to every cycle of chemotherapy,for 4 cycles)). 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 24 Jul 2013.