Breast CancerNCT03956875
Yoga for Aromatase Inhibitor-related Knee Pain Relief in Breast Cancer Patients
A study testing yoga in people with Breast Cancer and Aromatase Inhibitor, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
The purpose of the study was to investigate the therapeutic effect of Yoga on aromatic inhibitor-induced chronic knee pain in patients with breast cancer. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Breast Cancer, Aromatase Inhibitor, Yoga
- What is being tested?
- yoga
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Mar 2019to 5 Sep 2019
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with breast cancer and is taking an aromatic ring enzyme inhibitor. Knee joint pain for more than three months. Ages are over 20 years old and under 70 years old.
Who cannot join
- At the same time, there are multiple sources of pain associated with non-breast cancer, such as visceral pain, traumatic pain, which must be excluded by the moderator.
- Addicted drug abusers, subject to the judgment of the host. Women who may be pregnant, pregnant women, within three months after childbirth.
- Have a serious mental illness or an unstable mental state, which will affect the clinical assessment.
- Severe hearing impairment, visual impairment, or dementia. It is not easy to measure by the host.
- Limb edema and severe skin damage are not suitable for yoga practitioners by the physician.
- The spinal lesions are excessively severe, affecting the normal function of the operation, and the test cannot be completed.
- Have been a yoga practitioner for nearly a month, or a regular exerciser for over 90 minutes per week for the past month.
- Cancer has been transferred (stage IV)
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study was to investigate the therapeutic effect of Yoga on aromatic inhibitor-induced chronic knee pain in patients with breast cancer.
Read the detailed description
Estrogen plays a critical role in breast cancer growth in pre-and post-menopausal women. The aromatic catalyzer has relationship with biosynthesis of estrogen, therefore, aromatic inhibitors became as a standard therapy of breast cancer in post-menopausal women. Arthralgia and joint stiffness are most common side effect in aromatic inhibitor treatment. Yoga is benefit for the patients with chronic pain improvement, and also can improve quality of life. Therefore, the purpose of the present study was to investigate the therapeutic effect of Yoga on aromatic inhibitor-induced chronic knee pain in patients with breast cancer.The investigators designed a crossover study, a total of 60 patients divided equally to control group (massage for 6 weeks in home care) and treatment group (Yoga treatment for 12 times/6 weeks). There is two weeks wash out period after finishing 6 weeks treatment, and then the patients in control group changed to treatment, in contrast, the patients in the treatment changed to control group. The assessment time was pre-treatment (vision 1), finishing 6 weeks treatment (vision), finishing 6 weeks treatment after crossover (vision 3). The major assessment was brief pain inventory scores changed The results in the present study predict Yoga treatment for 6 weeks can improve aromatic inhibitor-induced knee pain and also can improve quality of life in patients with breast cancer.
- Conditions
- Breast Cancer, Aromatase Inhibitor, Yoga, Knee Pain
- Being tested
- yoga
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
yogaOther
Also called massage
yoga is a mind-body practice that guides the body through a series of poses and breathing exercises
| Study group | Role | What they receive |
|---|---|---|
| yoga | Active comparator | Yoga treatment Receives: Other: yoga |
| massage | Placebo comparator | massage Receives: Other: yoga |
What is being measured
The primary outcome is the main question the study is designed to answer.
womac questionnaire
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis.
Measured: 3 minutes
Secondary outcomes (1)
M.E.A.D (Meridian Energy Analysis Device)
The instrument mainly detects 24 representative points of the twelve meridians around the human body. The bioelectrical resistance of each meridian is measured by the test rod to evaluate the conductivity of each meridian, and the physiology of the subject is analyzed by computer. situation.
Measured: 5minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2019
- Study start10 Mar 2019
- Primary completion5 Sep 2019
- Study completion5 Sep 2019
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.
- More trials run by China Medical University HospitalThe 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
- Model description
- The investigators designed a crossover study, a total of 60 patients divided equally to control group (massage for 6 weeks in home care) and treatment group (Yoga treatment for 12 times/6 weeks).
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03956875
- Sponsor's protocol ID
- CMUH107-REC3-102
- Status last verified
- Dec 2019
- First submitted
- 17 May 2019
- Last updated
- 2 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yoga for Aromatase Inhibitor-related Knee Pain Relief in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT03956875
- Acronym / sponsor ID
- CMUH107-REC3-102
- Conditions
- Breast Cancer, Aromatase Inhibitor, Yoga, Knee Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 10 Mar 2019 (actual)
- Primary completion
- 5 Sep 2019 (actual)
- Study completion
- 5 Sep 2019 (actual)
- First posted
- 21 May 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 the study was to investigate the therapeutic effect of Yoga on aromatic inhibitor-induced chronic knee pain in patients with breast cancer.
Detailed description
Estrogen plays a critical role in breast cancer growth in pre-and post-menopausal women. The aromatic catalyzer has relationship with biosynthesis of estrogen, therefore, aromatic inhibitors became as a standard therapy of breast cancer in post-menopausal women. Arthralgia and joint stiffness are most common side effect in aromatic inhibitor treatment. Yoga is benefit for the patients with chronic pain improvement, and also can improve quality of life. Therefore, the purpose of the present study was to investigate the therapeutic effect of Yoga on aromatic inhibitor-induced chronic knee pain in patients with breast cancer.The investigators designed a crossover study, a total of 60 patients divided equally to control group (massage for 6 weeks in home care) and treatment group (Yoga treatment for 12 times/6 weeks). There is two weeks wash out period after finishing 6 weeks treatment, and then the patients in control group changed to treatment, in contrast, the patients in the treatment changed to control group. The assessment time was pre-treatment (vision 1), finishing 6 weeks treatment (vision), finishing 6 weeks treatment after crossover (vision 3). The major assessment was brief pain inventory scores changed The results in the present study predict Yoga treatment for 6 weeks can improve aromatic inhibitor-induced knee pain and also can improve quality of life in patients with breast cancer.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The investigators designed a crossover study, a total of 60 patients divided equally to control group (massage for 6 weeks in home care) and treatment group (Yoga treatment for 12 times/6 weeks).
| Arm | Type | Receives |
|---|---|---|
| yoga | Active comparator | Other: yogaYoga treatment |
| massage | Placebo comparator | Other: yogamassage |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosed with breast cancer and is taking an aromatic ring enzyme inhibitor. Knee joint pain for more than three months. Ages are over 20 years old and under 70 years old.
Key exclusion criteria (8 listed)
- At the same time, there are multiple sources of pain associated with non-breast cancer, such as visceral pain, traumatic pain, which must be excluded by the moderator.
- Addicted drug abusers, subject to the judgment of the host. Women who may be pregnant, pregnant women, within three months after childbirth.
- Have a serious mental illness or an unstable mental state, which will affect the clinical assessment.
- Severe hearing impairment, visual impairment, or dementia. It is not easy to measure by the host.
- Limb edema and severe skin damage are not suitable for yoga practitioners by the physician.
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 |
|---|---|---|
| yogaAlso: massageyoga is a mind-body practice that guides the body through a series of poses and breathing exercises | Other | massage, yoga |
Primary outcome
womac questionnaire
Time frame: 3 minutes
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis.
1 secondary outcome
M.E.A.D (Meridian Energy Analysis Device)
Time frame: 5minutes
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 Jan 2020.
- Individual participant dataSharing planned: Undecided. undecided
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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 yoga in people with Breast Cancer and Aromatase Inhibitor, run by China Medical University Hospital at 1 site in Taiwan.
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 1 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 2 Jan 2020. 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 Taiwan. 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. Some participants in this study may receive a placebo. 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?
womac questionnaire (time frame: 3 minutes). 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 2 Jan 2020.