Breast CancerNCT04042870
Effect of Sukshma Vyayama Yoga on Aromatase Inhibitor-Induced Arthralgia in Breast Cancer Survivors
A study testing Joint Loosening Yoga in people with Breast Cancer, run by AshtaYoga, LLC at 1 site in United States.
Trial summary
The purpose of this study is to investigate the efficacy of sukshma vyayama joint loosening yoga in improving aromatase inhibitor-induced arthralgia in post-menopausal breast cancer survivors and secondarily, to evaluate the feasibility of delivering the intervention on Facebook. Read more about this study
- Who is it for?
- Ages 35 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Joint Loosening Yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Sep 2018to 19 Oct 2018
- 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 35 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Postmenopausal breast cancer survivors undergoing treatment with aromatase inhibitor hormonal therapy with self-reported arthralgia
- Must have initiated anastrazole, exemestane, or letrozole within 30 days of baseline assessment
- 35-70 years old
- Must be available during the dates of the study and willing to participate in the study
- Must have access to computer, tablet or smart phone and Internet connection
- Must be a member of Facebook
- Eligible if their arthralgia started after initiation of an AI or if they had preexisting joint pain that was exacerbated by AI use
- English speaking
Who cannot join
- Non English-speaking
- Physically unable to perform the intervention
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: Effect of Sukshma Vyayama Joint Loosening Yoga on Aromatase Inhibitor-Induced Arthralgia in Post-Menopausal Breast Cancer Survivors: A Feasibility Study Conducted on Facebook
The purpose of this study is to investigate the efficacy of sukshma vyayama joint loosening yoga in improving aromatase inhibitor-induced arthralgia in post-menopausal breast cancer survivors and secondarily, to evaluate the feasibility of delivering the intervention on Facebook.
Read the detailed description
Cancer survival rates are improving in the United States but this increased survivorship is offset by persistent treatment related symptoms, particularly for post-menopausal breast cancer survivors treated with aromatase inhibitor (AI) hormonal therapy. AI therapy is well known to cause arthralgia that can compromise a woman's quality of life. National Comprehensive Cancer Center Network (NCCCN) guidelines for breast cancer treatment recommend that post-menopausal women with estrogen receptor-positive tumors receive aromatase inhibitors, e.g., anastrozole (Arimidex), letrozole (Femara) or exemestane (Aromasin) as a key part of treatment to lower the risk of breast cancer recurrence, breast cancer in the opposite breast, and death from breast cancer. Estrogen receptor-positive breast cancer represents almost 50% of all newly diagnosed cases of breast cancer. Currently, AIs are prescribed for five to ten years. The length of this treatment, coupled with difficult arthritic side effects can make it difficult for patients to complete therapy. Arthralgia occurs in up to 50% of breast cancer survivors treated with AIs and is the most common reason for poor AI adherence. Up to 50% of patients do not take AIs as prescribed and up to 20% will become non-compliant with treatment within the first year due to pain and discomfort. To get the most benefit out of hormone therapy, however, patients must take the full course of treatment. Both non-adherence and early discontinuation of AIs have been shown to be independent predictors of mortality. Women who complete the full course have better survival than those who do not. Given the efficacy of AIs in preventing breast cancer recurrence, and the proportion of women who discontinue these drugs because of adverse events, interventions to improve adverse effects are important.
This study investigated the efficacy of sukshma vyayama joint loosening yoga in reducing and improving aromatase inhibitor-induced joint pain and achiness in post-menopausal breast cancer patients, and evaluated the feasibility of delivering the intervention on Facebook. Hypothesis: Given global disparities in healthcare, being able to safely deliver evidence-based yoga interventions via the internet is important.
- Conditions
- Breast Cancer
- Being tested
- Joint Loosening Yoga
- Keywords
- Breast Cancer, Yoga, Aromatase Inhibitor, Arthralgia, Sukshma Vyayama
- Medical subject headings
- Breast Neoplasms, Arthralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Joint Loosening YogaBehavioural
Sukshma Vyayama Joint Loosening Yoga was practiced Monday - Friday for four weeks. Each session included twelve joint loosening exercises performed in a chair, each performed 10 times with mindful awareness of physical movements and breath synchronization. Sessions lasted 15 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Joint Loosening Yoga | Experimental | Yoga Intervention. Dose: 15 minutes, M-F for 4-weeks. Receives: Behavioral: Joint Loosening Yoga |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Patient-Reported Arthralgia Inventory (PRAI) Measure for Joint Arthralgia
The Patient-Reported Arthralgia Inventory measures self-reported pain intensity in 16 specific joints over the past 7 days. This questionnaire consists of 16 questions answered on a 0 to 10 scale (0 = no pain at all; 10 = worst pain you can imagine) with a min of 0 and a max of 160. Higher scores indicate more pain.
Measured: Baseline and Four weeks
Change in Brief Pain Inventory Short Form (BPI SF) Measure for Body Pain
The Brief Pain Inventory Short Form measures self-reported pain intensity in the body in the last 24-hours. This questionnaire consists of 8 questions (4 on pain quality) answered on a scale 0-10 (0 = no pain; 10 = pain as bad as you can imagine) with a min of 0 and a max of 40. Higher scores indicate more pain.
Measured: Baseline and Four weeks
Change in Brief Pain Inventory Short Form (BPI SF) Measure for Quality of Life
The Brief Pain Inventory Short Form measures self-reported QoL in the last 24-hours. This questionnaire consists of 7 questions answered on a scale 0-10 (0 = does not interfere; 10 = completely interferes) with a min of 0 and a max of 70. Higher scores indicate lower QoL.
Measured: Baseline and Four weeks
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Measure for Pain, Stiffness, and Physical Function of Knee and Hip
The Western Ontario and McMaster Universities Osteoarthritis Index measures self-reported pain, stiffness, and functional limitation of knee and hip during activity in the last 48-hours. This questionnaire consists of 24 questions answered on a scale 0-4 (0 = none; 4 = extreme). Measures include five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). Higher scores indicate greater pain, stiffness, and functional limitation.
Measured: Baseline and Four weeks
Change in Disability of the Arm, Shoulder and Hand (DASH) Measure of Ability to Use Arm, Shoulder, and Hand
The Disability of the Arm, Shoulder and Hand tool measures self-reported ability to do daily activities in the last week and impact on QoL. The questionnaire consists of 30 questions answered on a scale 1-5 (1 = no difficulty; 5 = unable) with a min of 30 and a max of 150. Measures include 21 items for daily functional activity (score range 30-105), two for interference with social or work activity (score range 2-10), five for pain and discomfort (score range 5-25), one for sleep (score range 1-5), and one for confidence (score range 1-5). Higher scores indicate greater pain and disability.
Measured: Baseline and Four weeks
Secondary outcomes (1)
Effectiveness of Delivering Intervention on Facebook
Measure whether sufficient numbers of subjects enroll in order to complete the study.
Measured: Four Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2019
- Study start4 Sep 2018
- Primary completion28 Sep 2018
- Study completion19 Oct 2018
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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pre / Post Single Control
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- AshtaYoga, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Columbia University, Swami Vivekananda Yoga Anusandhana Samsthana
- Responsible party
- Sponsor
- Investigators
- Leigh Leibel, MSc, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04042870
- Sponsor's protocol ID
- AI Yoga Study on Facebook - 1
- Status last verified
- Aug 2019
- First submitted
- 14 Jul 2019
- Last updated
- 2 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Leibel L, Metri K, Prasad R, Mears JG, Effect of Sukshma Vyayama on Aromatase Inhibitor-Induced Arthralgia in Post-Menopausal Breast Cancer Survivors: A Feasibility Study Conducted on Facebook, J Clin Oncol 37, 2019 (suppl; abstr e23129)
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sukshma Vyayama Joint Loosening Yoga on Aromatase Inhibitor-Induced Arthralgia in Post-Menopausal Breast Cancer Survivors: A Feasibility Study Conducted on Facebook
- ClinicalTrials.gov ID
- NCT04042870
- Acronym / sponsor ID
- AI Yoga Study on Facebook - 1
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Yoga, Aromatase Inhibitor, Arthralgia, Sukshma Vyayama
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- AshtaYoga, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Columbia University, Swami Vivekananda Yoga Anusandhana Samsthana
- Study start
- 4 Sep 2018 (actual)
- Primary completion
- 28 Sep 2018 (actual)
- Study completion
- 19 Oct 2018 (actual)
- First posted
- 2 Aug 2019 (actual)
- 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 investigate the efficacy of sukshma vyayama joint loosening yoga in improving aromatase inhibitor-induced arthralgia in post-menopausal breast cancer survivors and secondarily, to evaluate the feasibility of delivering the intervention on Facebook.
Detailed description
Cancer survival rates are improving in the United States but this increased survivorship is offset by persistent treatment related symptoms, particularly for post-menopausal breast cancer survivors treated with aromatase inhibitor (AI) hormonal therapy. AI therapy is well known to cause arthralgia that can compromise a woman's quality of life. National Comprehensive Cancer Center Network (NCCCN) guidelines for breast cancer treatment recommend that post-menopausal women with estrogen receptor-positive tumors receive aromatase inhibitors, e.g., anastrozole (Arimidex), letrozole (Femara) or exemestane (Aromasin) as a key part of treatment to lower the risk of breast cancer recurrence, breast cancer in the opposite breast, and death from breast cancer. Estrogen receptor-positive breast cancer represents almost 50% of all newly diagnosed cases of breast cancer. Currently, AIs are prescribed for five to ten years. The length of this treatment, coupled with difficult arthritic side effects can make it difficult for patients to complete therapy. Arthralgia occurs in up to 50% of breast cancer survivors treated with AIs and is the most common reason for poor AI adherence. Up to 50% of patients do not take AIs as prescribed and up to 20% will become non-compliant with treatment within the first year due to pain and discomfort. To get the most benefit out of hormone therapy, however, patients must take the full course of treatment. Both non-adherence and early discontinuation of AIs have been shown to be independent predictors of mortality. Women who complete the full course have better survival than those who do not. Given the efficacy of AIs in preventing breast cancer recurrence, and the proportion of women who discontinue these drugs because of adverse events, interventions to improve adverse effects are important.
This study investigated the efficacy of sukshma vyayama joint loosening yoga in reducing and improving aromatase inhibitor-induced joint pain and achiness in post-menopausal breast cancer patients, and evaluated the feasibility of delivering the intervention on Facebook. Hypothesis: Given global disparities in healthcare, being able to safely deliver evidence-based yoga interventions via the internet is important.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pre / Post Single Control
| Arm | Type | Receives |
|---|---|---|
| Joint Loosening Yoga | Experimental | Behavioral: Joint Loosening YogaYoga Intervention. Dose: 15 minutes, M-F for 4-weeks. |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Postmenopausal breast cancer survivors undergoing treatment with aromatase inhibitor hormonal therapy with self-reported arthralgia
- Must have initiated anastrazole, exemestane, or letrozole within 30 days of baseline assessment
- 35-70 years old
- Must be available during the dates of the study and willing to participate in the study
- Must have access to computer, tablet or smart phone and Internet connection
Key exclusion criteria (2 listed)
- Non English-speaking
- Physically unable to perform the intervention
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 |
|---|---|---|
| Joint Loosening YogaSukshma Vyayama Joint Loosening Yoga was practiced Monday - Friday for four weeks. Each session included twelve joint loosening exercises performed in a chair, each performed 10 times with mindful awareness of physical movements and breath synchronization. Sessions lasted 15 minutes. | Behavioural | Joint Loosening Yoga |
Primary outcome
Change in Patient-Reported Arthralgia Inventory (PRAI) Measure for Joint Arthralgia
Time frame: Baseline and Four weeks
The Patient-Reported Arthralgia Inventory measures self-reported pain intensity in 16 specific joints over the past 7 days. This questionnaire consists of 16 questions answered on a 0 to 10 scale (0 = no pain at all; 10 = worst pain you can imagine) with a min of 0 and a max of 160. Higher scores indicate more pain.
Change in Brief Pain Inventory Short Form (BPI SF) Measure for Body Pain
Time frame: Baseline and Four weeks
The Brief Pain Inventory Short Form measures self-reported pain intensity in the body in the last 24-hours. This questionnaire consists of 8 questions (4 on pain quality) answered on a scale 0-10 (0 = no pain; 10 = pain as bad as you can imagine) with a min of 0 and a max of 40. Higher scores indicate more pain.
Change in Brief Pain Inventory Short Form (BPI SF) Measure for Quality of Life
Time frame: Baseline and Four weeks
The Brief Pain Inventory Short Form measures self-reported QoL in the last 24-hours. This questionnaire consists of 7 questions answered on a scale 0-10 (0 = does not interfere; 10 = completely interferes) with a min of 0 and a max of 70. Higher scores indicate lower QoL.
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Measure for Pain, Stiffness, and Physical Function of Knee and Hip
Time frame: Baseline and Four weeks
The Western Ontario and McMaster Universities Osteoarthritis Index measures self-reported pain, stiffness, and functional limitation of knee and hip during activity in the last 48-hours. This questionnaire consists of 24 questions answered on a scale 0-4 (0 = none; 4 = extreme). Measures include five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). Higher scores indicate greater pain, stiffness, and functional limitation.
Change in Disability of the Arm, Shoulder and Hand (DASH) Measure of Ability to Use Arm, Shoulder, and Hand
Time frame: Baseline and Four weeks
The Disability of the Arm, Shoulder and Hand tool measures self-reported ability to do daily activities in the last week and impact on QoL. The questionnaire consists of 30 questions answered on a scale 1-5 (1 = no difficulty; 5 = unable) with a min of 30 and a max of 150. Measures include 21 items for daily functional activity (score range 30-105), two for interference with social or work activity (score range 2-10), five for pain and discomfort (score range 5-25), one for sleep (score range 1-5), and one for confidence (score range 1-5). Higher scores indicate greater pain and disability.
1 secondary outcome
Effectiveness of Delivering Intervention on Facebook
Time frame: Four Weeks
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 2 Aug 2019.
- Results publicationLeibel L, Metri K, Prasad R, Mears JG, Effect of Sukshma Vyayama on Aromatase Inhibitor-Induced Arthralgia in Post-Menopausal Breast Cancer Survivors: A Feasibility Study Conducted on Facebook, J Clin Oncol 37, 2019 (suppl; abstr e23129)
- Individual participant dataSharing planned: No
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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.
Leigh Leibel, MSc principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Joint Loosening Yoga in people with Breast Cancer, run by AshtaYoga, LLC 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 8 inclusion and 2 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 2 Aug 2019. 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?
Change in Patient-Reported Arthralgia Inventory (PRAI) Measure for Joint Arthralgia (time frame: Baseline and Four weeks). The study lists 5 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 NCT04042870, 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 2 Aug 2019.