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

Not Applicable

Completed

• Conditions: Lymphedema
• Interventions: Other: ITP

• Registration Number: NCT02528539
• Lead Sponsor: Huntington Memorial Hospital

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.

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2015-08-17
• Study First Submitted QC: 2015-08-18
• Study First Posted: 2015-08-19
• Primary Completion: 2015-08-30
• Study Completion: 2016-12-30
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-14
• Last Update Posted: 2022-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ITP (Integrative Thearpy Program)	ITP	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

Primary Outcome Measures

Name	Time	Method
Arm circumference measurements of the upper limbs using at 4 cm interval	18 months	measure the circumference in centimeters
Bioimpedance (L-dex U400)	18 months	use L-dex machine

Secondary Outcome Measures

Name	Time	Method
Quality of Life (Functional Assessment of Cancer Therapy-Breast)	18 months	survey
Self-Efficacy Scale	18 months	questionnaires
Lymphedema Knowledge Scale	18 months	questionnaires
Wong-Baker FACES Pain Scale	18 months	1-10 scale

Trial Locations

Locations (1)

Huntington Memorial Hospital; 🇺🇸 Pasadena, California, United States