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

Primary Purpose

Breast Cancer, Aromatase Inhibitor, Yoga

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
yoga
Sponsored by
China Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Ching-Liang Hsieh

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

yoga

massage

Arm Description

Yoga treatment

massage

Outcomes

Primary Outcome Measures

womac questionnaire
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis.

Secondary Outcome Measures

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.

Full Information

First Posted
May 17, 2019
Last Updated
December 27, 2019
Sponsor
China Medical University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03956875
Brief Title
Yoga for Aromatase Inhibitor-related Knee Pain Relief in Breast Cancer Patients
Official Title
Yoga for Aromatase Inhibitor-related Knee Pain Relief in Breast Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
March 10, 2019 (Actual)
Primary Completion Date
September 5, 2019 (Actual)
Study Completion Date
September 5, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China Medical University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Aromatase Inhibitor, Yoga, Knee Pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
yoga
Arm Type
Active Comparator
Arm Description
Yoga treatment
Arm Title
massage
Arm Type
Placebo Comparator
Arm Description
massage
Intervention Type
Other
Intervention Name(s)
yoga
Other Intervention Name(s)
massage
Intervention Description
yoga is a mind-body practice that guides the body through a series of poses and breathing exercises
Primary Outcome Measure Information:
Title
womac questionnaire
Description
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis.
Time Frame
3 minutes
Secondary Outcome Measure Information:
Title
M.E.A.D (Meridian Energy Analysis Device)
Description
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.
Time Frame
5minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Facility Information:
Facility Name
Ching-Liang Hsieh
City
Taichung
ZIP/Postal Code
404
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
undecided

Learn more about this trial

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

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