Lymphedema Clinical Trial
Official title:
Feasibility and Preliminary Efficacy of Hatha Yoga in Breast Cancer Survivors: Pilot Study
Verified date | March 2019 |
Source | Vanderbilt-Ingram Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This pilot clinical trial studies Hatha yoga in reducing physical and emotional problems in breast cancer survivors with stage II-III lymphedema. Yoga practices may benefit breast cancer survivors with lymphedema as they directly support lymph transport (postures, breathing, relaxation) and emotional well-being (relaxation, meditation).
Status | Terminated |
Enrollment | 27 |
Est. completion date | March 2019 |
Est. primary completion date | November 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: Lymphedema Group: - Lymphedema, symptomatic of stage II or III based upon screening responses; or L-Dex reading of = 7 at initial visit, - > 3 months (mths) post-breast cancer treatment - No active cancer - Has compression sleeve - Ability to understand English in order to complete questionnaires - Willing to do guided and home yoga practice - Willing and able to provide informed consent as demonstrated by passing screening tool questions that includes the Short Portable Mental Status Questionnaire - Medical clearance - Reliable transportation to the study site No Lymphedema Group: - No known lymphedema or intermittent swelling, not symptomatic of Stage II or III lymphedema (L-Dex = 7) - >3 months post- breast cancer treatment - No active cancer - Ability to understand English in order to complete questionnaires - Willing to do guided and home Yoga practice - Willing and able to provide informed consent as demonstrated by passing screening tool questions that includes the Short Portable Mental Status Questionnaire - Medical clearance - Reliable transportation to the study site. Exclusion Criteria (Both Groups): - Active cancer - Undergoing radiation therapy or chemotherapy - Medical conditions that would prohibit the safe implementation of a yoga practice (e.g., vertigo, compromised mental status) - Active yoga practice < 3 months - Currently undergoing phase I complete decongestive therapy (CDT) - Inability to complete study forms |
Country | Name | City | State |
---|---|---|---|
United States | Vanderbilt University School of Nursing | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt-Ingram Cancer Center | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pose Modifications | number of poses requiring modifications as indicated in the modification form | Up to 8 weeks | |
Primary | Assess safety | Number of participants with treatment-related adverse events as assessed by the CTCAE v4.0 | Up to 8 weeks |
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