Clinical trial NCT02528539: Prevention of Lymphedema Among Breast Cancer Patients Through Implementation of an Integrative Therapy Program (ITP)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymphedema
Keywords: Prevention
lymphedema
acupuncture
self-management
Lead sponsor: Huntington Memorial Hospital
Sponsor class: OTHER
First posted: 2015-08-19
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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

Detailed description: 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:

1. Lymphedema knowledge: functions of the lymphatic system, anatomy of the lymph nodes and direction of the lymphatic drainage, risk factors that could precipitate lymphedema, the signs and symptoms of lymphedema and infection, and lymphedema resources.
2. Selfcare techniques:healthy diet (eating whole food encouraged), neck, shoulder and chest wall stretching exercises, walk daily, self-manual lymphatic drainage with deep breathing techniques, and self-acupressure over eighteen months following their surgery.

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.

Eligibility criteria: Inclusion Criteria:

1. Subjects must be able to read and understand the informed consent form and have the capacity to give consent.
2. Adults age 18 and older
3. Subject with a newly diagnosed stage I-III breast cancer with a documented pre-operative baseline L-Dex U400 who underwent axillary lymph node dissection within 4-6 weeks prior to enrollment.
4. Subjects must be able to return to the study site for the duration of the study (18 months).

Exclusion Criteria:

1. Subjects who do not read or understand the informed consent are ineligible.
2. Subjects who have any contraindications to the affected upper-limb exercises, which include congestive heart failure, cardiac arrhythmia, deep vein thrombosis, infectious disease complications such as cellulitis and lymphangitis.
3. Women with double mastectomy with axillary node dissection bilaterally.
4. Women with a prior history of axillary surgeries in the ipsilateral side and/or primary lymphedema
5. Women with metal implants (e.g. shoulder replacement) or cardiac implants (e.g. automated implanted cardiac defibrillator (AICD) or pacemaker).
6. All subjects with objective or subjective signs and symptoms of lymphedema.
7. Women of childbearing age who are pregnant.

Primary outcomes:
measure: Bioimpedance (L-dex U400)
timeFrame: 18 months
measure: Arm circumference measurements of the upper limbs using at 4 cm interval
timeFrame: 18 months
Secondary outcomes:
measure: Self-Efficacy Scale
timeFrame: 18 months
measure: Lymphedema Knowledge Scale
timeFrame: 18 months
measure: Quality of Life (Functional Assessment of Cancer Therapy-Breast)
timeFrame: 18 months
measure: Wong-Baker FACES Pain Scale
timeFrame: 18 months
Other outcomes:
Locations:
city: Pasadena
country: United States
facility: Huntington Memorial Hospital
state: California
Study officials:
affiliation: Huntington Hospital
name: Suzie S Kline, PhD
role: PRINCIPAL_INVESTIGATOR
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