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Completed

NCT Number: NCT02528539

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

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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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Huntington Memorial Hospital

Pasadena, California, 91105, United States

About this study

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:

  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects must be able to read and understand the informed consent form and have the capacity to give consent.
  • Adults age 18 and older
  • 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.
  • Subjects must be able to return to the study site for the duration of the study (18 months).

Exclusion criteria

  • Subjects who do not read or understand the informed consent are ineligible.
  • 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.
  • Women with double mastectomy with axillary node dissection bilaterally.
  • Women with a prior history of axillary surgeries in the ipsilateral side and/or primary lymphedema
  • Women with metal implants (e.g. shoulder replacement) or cardiac implants (e.g. automated implanted cardiac defibrillator (AICD) or pacemaker).
  • All subjects with objective or subjective signs and symptoms of lymphedema.
  • Women of childbearing age who are pregnant.

Treatment and study plan

ITP

Other

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

Primary outcomes

  1. Bioimpedance (L-dex U400)

    Time frame: 18 months

    use L-dex machine

  2. Arm circumference measurements of the upper limbs using at 4 cm interval

    Time frame: 18 months

    measure the circumference in centimeters

Secondary outcomes

  1. Self-Efficacy Scale

    Time frame: 18 months

    questionnaires

  2. Lymphedema Knowledge Scale

    Time frame: 18 months

    questionnaires

  3. Quality of Life (Functional Assessment of Cancer Therapy-Breast)

    Time frame: 18 months

    survey

  4. Wong-Baker FACES Pain Scale

    Time frame: 18 months

    1-10 scale

Sponsors and collaborators

Lead sponsor

Huntington Memorial Hospital

Other

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Aug 19, 2015
Registry last updated
Mar 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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