Huntington Memorial Hospital
Pasadena, California, 91105, United States
NCT Number: NCT02528539
Introduction: Breast cancer women who are treated with axillary node dissection are at increased risk for lymphedema - the lifetime risk in these women is estimated at 15-50% and the risk can significantly increase with chemotherapy and radiation therapy
Objectives:
1. To evaluate the feasibility and effectiveness of implementing the integrative therapy program (ITP) intervention. ITP consists of self-management education in conjunction with acupuncture. 2. To determine if ITP affects quality of life, self-efficacy, lymphedema knowledge, pain, and early detection and management of lymphedema.
Design: the exploratory study aims to evaluate the feasibility and benefits of the integrative therapy program (ITP) intervention post-operatively for 18 months.
Subjects: Women with breast cancer treated with axillary node dissection with normal baseline pre-operative bioimpedance (L-dex U400) score.
Sample size: 30 subjects
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Notify Me18 year and older
Female
Interventional
Not applicable
Pasadena, California, 91105, United States
Recruitment and Intervention:
The study participants are recruited by their breast surgeon after they undergo axillary node dissection surgery. 4-6 weeks following surgery, the participants will receive a combination of acupuncture and self management education .
Contents of self-management education include:
Outcome measurements include: L-Dex U400 measurement, arm circumference, pain scale, self-efficacy, and lymphedema knowledge, and Functional Assessment of Cancer Therapy-Breast FACT-B.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The study participants will receive weekly acupuncture treatment plus education on self-management for 10 weeks after axillary node dissection, then a total of five follow up acupuncture treatments once every 3 months at 6, 9, 12, 15, and 18 months. The education and self management will be reinforced monthly by telephone visit.
Acupuncture points include: LI 4, LV3, HT3, SP9, GB 20, KD 3, Yintang, and Ashi points
Other names: Integrative Therapy Program
Time frame: 18 months
use L-dex machine
Time frame: 18 months
measure the circumference in centimeters
Time frame: 18 months
questionnaires
Time frame: 18 months
questionnaires
Time frame: 18 months
survey
Time frame: 18 months
1-10 scale
Huntington Memorial Hospital
Other
Prevention of Secondary Lymphedema by Utilizing Self-management Education in Conjunction With Acupuncture Among Breast Cancer Patients Who Are at High Risk of Developing Lymphedema
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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