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Prevention of Lymphedema Among Breast Cancer Patients Through Implementation of an Integrative Therapy Program (ITP)

Sponsor
Huntington Memorial Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02528539
Collaborator
(none)
10
Enrollment
1
Location
1
Arm
41
Actual Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Other: ITP
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
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
Actual Study Start Date :
Aug 1, 2013
Actual Primary Completion Date :
Aug 30, 2015
Actual Study Completion Date :
Dec 30, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: ITP (Integrative Thearpy Program)

This ITP intervention consists of two distinct phases, Phase I, the active treatment phase and Phase II, the follow-up phase. Phase I (Intervention phase) begins post-operatively in 4-6 weeks with a baseline visit that includes 30-minute acupuncture treatment, followed by the 30-minute self-management educational session, and the participants will return weekly for 10 weeks. Phase II (Follow up phase) begins at month 6 and ends at month 18 from the surgery. The phase II consists of 1-hour quarterly ITP therapy at months 6, 9, 12, 15, and 18 and monthly telephone visits between ITP therapies at months 7, 8, 10, 11, 13, 14, 16, and 17. Self-management reinforcement and support will be implemented during telephone follow up visits

Other: ITP
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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Bioimpedance (L-dex U400) [18 months]

      use L-dex machine

    2. Arm circumference measurements of the upper limbs using at 4 cm interval [18 months]

      measure the circumference in centimeters

    Secondary Outcome Measures

    1. Self-Efficacy Scale [18 months]

      questionnaires

    2. Lymphedema Knowledge Scale [18 months]

      questionnaires

    3. Quality of Life (Functional Assessment of Cancer Therapy-Breast) [18 months]

      survey

    4. Wong-Baker FACES Pain Scale [18 months]

      1-10 scale

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Huntington Memorial Hospital Pasadena California United States 91105

    Sponsors and Collaborators

    • Huntington Memorial Hospital

    Investigators

    • Principal Investigator: Suzie S Kline, PhD, Huntington Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Suzie Kline, PhD, NP, LAc, Huntington Memorial Hospital
    ClinicalTrials.gov Identifier:
    NCT02528539
    Other Study ID Numbers:
    • HMH2015.002
    First Posted:
    Aug 19, 2015
    Last Update Posted:
    Mar 2, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Suzie Kline, PhD, NP, LAc, Huntington Memorial Hospital
    Prevention
    lymphedema
    acupuncture
    self-management
    Additional relevant MeSH terms:
    Lymphedema

    Study Results

    No Results Posted as of Mar 2, 2022