Identification of a Screening Tool and Treatment of Lymphedema Secondary to the Management of Breast Cancer Study
| Status: | Terminated |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/25/2017 |
| Start Date: | January 2006 |
| End Date: | November 2007 |
The proposed research is designed to establish lymphedema incidence rates for a varied
population of breast cancer patients. Patients with breast preservation, mastectomy,
sentinel lymph node biopsy, axillary dissection and radiation therapy will be included with
the goal of determining the impact that each of these treatments has on development of
lymphedema. Establishing incidence in these populations is crucial to the remainder of the
study. We conduct a two phase study. The first phase will use arm measurements, a symptom
survey (The Lymphedema and Breast Questionnaire), a functional survey (Disability of the
Arm, Shoulder, and Hand Questionnaire), and operative and pathology information to create a
simple screening tool to predict the development of lymphedema. Currently, lymphedema is
only diagnosed after arm swelling develops. The goal of the screening tool is to identify
those patients at significantly increased risk for development of lymphedema as compared to
the general population of breast cancer survivors. Phase 2 of the study will test a
lymphedema prevention strategy in a high risk population. The goal of this phase is to
reduce the incidence of lymphedema in those patients that have undergone an axillary node
dissection with radiation therapy by using a combination of education, a compression sleeve
and decongestive exercises. If prevention is successful, the development of a screening tool
becomes even more important to identify those patients that should undergo a prevention
regimen.
population of breast cancer patients. Patients with breast preservation, mastectomy,
sentinel lymph node biopsy, axillary dissection and radiation therapy will be included with
the goal of determining the impact that each of these treatments has on development of
lymphedema. Establishing incidence in these populations is crucial to the remainder of the
study. We conduct a two phase study. The first phase will use arm measurements, a symptom
survey (The Lymphedema and Breast Questionnaire), a functional survey (Disability of the
Arm, Shoulder, and Hand Questionnaire), and operative and pathology information to create a
simple screening tool to predict the development of lymphedema. Currently, lymphedema is
only diagnosed after arm swelling develops. The goal of the screening tool is to identify
those patients at significantly increased risk for development of lymphedema as compared to
the general population of breast cancer survivors. Phase 2 of the study will test a
lymphedema prevention strategy in a high risk population. The goal of this phase is to
reduce the incidence of lymphedema in those patients that have undergone an axillary node
dissection with radiation therapy by using a combination of education, a compression sleeve
and decongestive exercises. If prevention is successful, the development of a screening tool
becomes even more important to identify those patients that should undergo a prevention
regimen.
Background: Lymphedema has varied definitions, all based on limb volume changes. None
incorporates limb volume changes, symptoms, and functional deficits. We will determine the
incidence of lymphedema in breast cancer patients and the impact of breast conserving
therapy, radiation therapy, sentinel lymph node biopsy, and axillary node dissection. The
impact of lymphedema can be evaluated in a number of ways; 1) The Lymphedema and Breast
Cancer Questionnaire (LBCQ) identifies symptoms that are unique to patients with lymphedema
and 2) The Disability of the Arm, Hand, and Shoulder (DASH) survey will be used to determine
the functional impact of lymphedema.
Objective/Hypothesis: Our hypotheses are: 1) Local therapies for breast cancer result in
different lymphedema rates depending on the combination of therapies used. 2) A simple
screening tool that incorporates symptoms, limb volume measurements, and tumor staging and
treatment modalities can predict those patients that will develop lymphedema. 3) Functional
impairment of the arm is severe in patients with lymphedema. 4) Prevention of lymphedema in
a high risk population is possible with education, a compression sleeve, and decongestive
exercise.
Specific Aims: 1) Evaluate patients both pre-operatively and at specific time intervals
post-operatively to establish the incidence of lymphedema in sentinel lymph node biopsy and
axillary dissection groups. 2) Create a simple screening tool using arm measurements,
symptoms identified by the LBCQ, and treatment and staging information to identify patients
that should go on to further testing and treatment. 3) Utilize the DASH survey to measure
the extent of disability from lymphedema and surgical treatment. 4) Conduct a randomized
trial of lymphedema prevention in a high-risk breast cancer population.
Study Design: This proposal will be conducted in two phases. Phase 1 will accomplish
Specific Aim 1, 2, and 3. Patients with newly diagnosed breast cancer awaiting definitive
surgery, will be enrolled pre-operatively and undergo arm measurements and complete the LBCQ
and the DASH surveys. These same study procedures will be completed at 1, 3, 6, 12, 18, and
24 months postoperative. Documentation collected during the study will include: demographic
information; co-morbid conditions; operative and pathology reports; and use of adjuvant
therapies such as chemotherapy, hormonal therapy, and radiation therapy. Incidence rates of
lymphedema and the impact of extent of surgery and radiation therapy will be determined. We
will also use this information to develop a simple screening tool to identify patients that
will develop lymphedema prior to the development of significant limb volume changes.
Specific Aim 4 is Phase 2 of the proposal. A high risk population (those that have an
axillary node dissection and radiation therapy) will be randomized to standard education
versus standard education, compression sleeve, and exercise. The effectiveness of prevention
to reduce incidence and severity of lymphedema and the impact on symptoms and functional
impairment will be determined. This work will move toward a new paradigm of lymphedema
management with a simple screening tool to identify high risk patients before significant
swelling occurs and investigate prevention strategies to decrease the incidence of
lymphedema.
Cancer Relevance: Lymphedema is a feared complication of breast cancer treatment. Currently
it is recognized and treated only after development of significant limb volume changes when
it is symptomatic and difficult to treat. Documentation of the impact of local therapies on
the development of lymphedema will allow clinicians to make more informed decisions
regarding risk benefit ratios of each of our local therapies. Development of a screening
tool will allow us to identify high risk populations. Ideally, the high risk population will
be identified and an effective prevention strategy implemented. Phase one of this study will
help to answer the questions regarding incidence and create a screening tool and phase two
will allow the evaluation of a prevention strategy.
incorporates limb volume changes, symptoms, and functional deficits. We will determine the
incidence of lymphedema in breast cancer patients and the impact of breast conserving
therapy, radiation therapy, sentinel lymph node biopsy, and axillary node dissection. The
impact of lymphedema can be evaluated in a number of ways; 1) The Lymphedema and Breast
Cancer Questionnaire (LBCQ) identifies symptoms that are unique to patients with lymphedema
and 2) The Disability of the Arm, Hand, and Shoulder (DASH) survey will be used to determine
the functional impact of lymphedema.
Objective/Hypothesis: Our hypotheses are: 1) Local therapies for breast cancer result in
different lymphedema rates depending on the combination of therapies used. 2) A simple
screening tool that incorporates symptoms, limb volume measurements, and tumor staging and
treatment modalities can predict those patients that will develop lymphedema. 3) Functional
impairment of the arm is severe in patients with lymphedema. 4) Prevention of lymphedema in
a high risk population is possible with education, a compression sleeve, and decongestive
exercise.
Specific Aims: 1) Evaluate patients both pre-operatively and at specific time intervals
post-operatively to establish the incidence of lymphedema in sentinel lymph node biopsy and
axillary dissection groups. 2) Create a simple screening tool using arm measurements,
symptoms identified by the LBCQ, and treatment and staging information to identify patients
that should go on to further testing and treatment. 3) Utilize the DASH survey to measure
the extent of disability from lymphedema and surgical treatment. 4) Conduct a randomized
trial of lymphedema prevention in a high-risk breast cancer population.
Study Design: This proposal will be conducted in two phases. Phase 1 will accomplish
Specific Aim 1, 2, and 3. Patients with newly diagnosed breast cancer awaiting definitive
surgery, will be enrolled pre-operatively and undergo arm measurements and complete the LBCQ
and the DASH surveys. These same study procedures will be completed at 1, 3, 6, 12, 18, and
24 months postoperative. Documentation collected during the study will include: demographic
information; co-morbid conditions; operative and pathology reports; and use of adjuvant
therapies such as chemotherapy, hormonal therapy, and radiation therapy. Incidence rates of
lymphedema and the impact of extent of surgery and radiation therapy will be determined. We
will also use this information to develop a simple screening tool to identify patients that
will develop lymphedema prior to the development of significant limb volume changes.
Specific Aim 4 is Phase 2 of the proposal. A high risk population (those that have an
axillary node dissection and radiation therapy) will be randomized to standard education
versus standard education, compression sleeve, and exercise. The effectiveness of prevention
to reduce incidence and severity of lymphedema and the impact on symptoms and functional
impairment will be determined. This work will move toward a new paradigm of lymphedema
management with a simple screening tool to identify high risk patients before significant
swelling occurs and investigate prevention strategies to decrease the incidence of
lymphedema.
Cancer Relevance: Lymphedema is a feared complication of breast cancer treatment. Currently
it is recognized and treated only after development of significant limb volume changes when
it is symptomatic and difficult to treat. Documentation of the impact of local therapies on
the development of lymphedema will allow clinicians to make more informed decisions
regarding risk benefit ratios of each of our local therapies. Development of a screening
tool will allow us to identify high risk populations. Ideally, the high risk population will
be identified and an effective prevention strategy implemented. Phase one of this study will
help to answer the questions regarding incidence and create a screening tool and phase two
will allow the evaluation of a prevention strategy.
Inclusion Criteria:
Age of 18 years or older, biopsy proven breast cancer with no known metastatic cancer,
surgical management of breast cancer with node evaluation to be completed at Johns Hopkins
Hospital, ability to speak and read English, willing and able to continue follow-up at
Johns Hopkins Avon foundation Breast Center -
Exclusion Criteria: Known psychiatric illness, unwillingness to be followed for two years,
functional arm deficits, prior radiation therapy to the breast or axilla, any prior
diagnosis of cancer except basal cell cancer
We found this trial at
1
site
1800 Orleans Street
Baltimore, Maryland 21287
Baltimore, Maryland 21287
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