Back to resultsPrevention of Lymphedema Among Breast Cancer Patients Through Implementation of an Integrative Therapy Program (ITP)
Primary Purpose
Lymphedema
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ITP
Sponsored by
About this trial
This is an interventional prevention trial for Lymphedema focused on measuring Prevention, lymphedema, acupuncture, self-management
Eligibility Criteria
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.
Sites / Locations
- Huntington Memorial Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ITP (Integrative Thearpy Program)
Arm Description
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
Outcomes
Primary Outcome Measures
Bioimpedance (L-dex U400)
use L-dex machine
Arm circumference measurements of the upper limbs using at 4 cm interval
measure the circumference in centimeters
Secondary Outcome Measures
Self-Efficacy Scale
questionnaires
Lymphedema Knowledge Scale
questionnaires
Quality of Life (Functional Assessment of Cancer Therapy-Breast)
survey
Wong-Baker FACES Pain Scale
1-10 scale
Full Information
NCT ID
NCT02528539
First Posted
August 17, 2015
Last Updated
February 14, 2022
Sponsor
Huntington Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02528539
Brief Title
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
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
August 2013 (Actual)
Primary Completion Date
August 30, 2015 (Actual)
Study Completion Date
December 30, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Huntington Memorial Hospital
4. Oversight
Data Monitoring Committee
No
5. 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:
To evaluate the feasibility and effectiveness of implementing the integrative therapy program (ITP) intervention. ITP consists of self-management education in conjunction with acupuncture.
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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphedema
Keywords
Prevention, lymphedema, acupuncture, self-management
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ITP (Integrative Thearpy Program)
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
ITP
Other Intervention Name(s)
Integrative Therapy Program
Intervention Description
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
Primary Outcome Measure Information:
Title
Bioimpedance (L-dex U400)
Description
use L-dex machine
Time Frame
18 months
Title
Arm circumference measurements of the upper limbs using at 4 cm interval
Description
measure the circumference in centimeters
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Self-Efficacy Scale
Description
questionnaires
Time Frame
18 months
Title
Lymphedema Knowledge Scale
Description
questionnaires
Time Frame
18 months
Title
Quality of Life (Functional Assessment of Cancer Therapy-Breast)
Description
survey
Time Frame
18 months
Title
Wong-Baker FACES Pain Scale
Description
1-10 scale
Time Frame
18 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzie S Kline, PhD
Organizational Affiliation
Huntington Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Huntington Memorial Hospital
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Prevention of Lymphedema Among Breast Cancer Patients Through Implementation of an Integrative Therapy Program (ITP)
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