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

NCT ID: NCT03956875

Last Updated: 2020-01-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-10
• Study Completion Date: 2019-09-05

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.

Conditions

Breast Cancer; Aromatase Inhibitor; Yoga; Knee Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

yoga

Yoga treatment

Group Type: ACTIVE_COMPARATOR

yoga

Intervention Type: OTHER

yoga is a mind-body practice that guides the body through a series of poses and breathing exercises

massage

massage

Group Type: PLACEBO_COMPARATOR

yoga

Intervention Type: OTHER

yoga is a mind-body practice that guides the body through a series of poses and breathing exercises

Interventions

yoga

yoga is a mind-body practice that guides the body through a series of poses and breathing exercises

Intervention Type: OTHER

Other Intervention Names

massage

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)

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China Medical University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ching-Liang Hsieh

Taichung, , Taiwan

Countries

Taiwan

Other Identifiers

CMUH107-REC3-102

Identifier Type: -

Identifier Source: org_study_id