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Yoga for Aromatase Inhibitor-related Knee Pain Relief in Breast Cancer Patients

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ClinicalTrials.gov Identifier: NCT03956875
Recruitment Status : Recruiting
First Posted : May 21, 2019
Last Update Posted : May 21, 2019
Sponsor:
Information provided by (Responsible Party):
China Medical University Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Aromatase Inhibitor Yoga Knee Pain Other: yoga Not Applicable

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. We 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: We 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)
Primary Purpose: Supportive Care
Official Title: Yoga for Aromatase Inhibitor-related Knee Pain Relief in Breast Cancer Patients
Actual Study Start Date : March 10, 2019
Estimated Primary Completion Date : September 5, 2019
Estimated Study Completion Date : September 5, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Active Comparator: yoga
Yoga treatment
Other: yoga
yoga is a mind-body practice that guides the body through a series of poses and breathing exercises
Other Name: massage

Placebo Comparator: massage
massage
Other: yoga
yoga is a mind-body practice that guides the body through a series of poses and breathing exercises
Other Name: massage




Primary Outcome Measures :
  1. womac questionnaire [ Time Frame: 3 mins ]
    The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis.


Secondary Outcome Measures :
  1. M.E.A.D (Meridian Energy Analysis Device) [ Time Frame: 5mins ]
    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.



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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03956875


Contacts
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Contact: Ching-Liang Hsieh, PhD 0975682012 clhsieh@mail.cmuh.org.tw

Locations
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Taiwan
Ching-Liang Hsieh Recruiting
Taichung, Taiwan, 404
Contact: Ching-Liang Hsieh, PhD    0975682012 ext 0975682012    clhsieh@mail.cmuh.org.tw   
Contact: Ching-Liang Hsieh    0975682012 ext 0975682012    clhsieh@mail.cmuh.org.tw   
Sponsors and Collaborators
China Medical University Hospital

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Responsible Party: China Medical University Hospital
ClinicalTrials.gov Identifier: NCT03956875     History of Changes
Other Study ID Numbers: CMUH107-REC3-102
First Posted: May 21, 2019    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs