Complete Decongestive Therapy in Breast Cancer-Related Lymphedema
Primary Purpose
Lymphedema of Upper Limb
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Standard of care complete decongestive therapy
Sponsored by
About this trial
This is an interventional treatment trial for Lymphedema of Upper Limb focused on measuring Breast Cancer, Lymphedema
Eligibility Criteria
Inclusion Criteria:
- Have active unilateral breast cancer-related lymphedema
- Medically stable
- Have not participated in lymphedema therapy the past 3 months
- An affected limb volume measurement of >10% excess volume
Ages 18-95 years old
- Patients undergoing any medical treatment for their breast cancer diagnosis will be included in this study.
- Patients with any stage breast cancer will be included in this study.
- Patients with a prior diagnosis of breast cancer, other cancer will be included in this study. There is no minimum time requirement that has prolapsed between their diagnosis and this study.
All subjects must have given signed, informed consent prior to registration on study.
Exclusion Criteria:
- Prophylactic treatment indicated
- A presence of upper extremity wounds present
- Active signs of infection or deep vein thrombosis (DVT)
- Bilateral lymphedema present
- Evidence of contraindications to CDT: uncontrolled hypertension, heart disease including congestive heart failure, and renal insufficiency
- Severe lymphedema present as defined by > 30% increase in limb volume
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Treatment 2x/wk
Treatment 4x/wk
Arm Description
Participants will receive standard of care complete decongestive therapy 2x/wk for 4 weeks.
Participants will receive standard of care complete decongestive therapy 4x/wk for 4 weeks.
Outcomes
Primary Outcome Measures
Change from baseline in impairments in function, activity limitations, and participation restrictions
A questionnaire looking at impairments in function, activity limitations, and participation restrictions consists of 29 questions divided into five domains: physical function, mental function, household activities, mobility activities, and life and social activities.
Changes from baseline in symptoms associated with lymphedema
This outcome measure will assess the presence of symptoms associated with lymphedema.
Secondary Outcome Measures
Changes from baseline in lymphedema volume
Circumferential measurements by tape measure calculated into volume percentage
Full Information
NCT ID
NCT02458391
First Posted
November 17, 2014
Last Updated
October 23, 2018
Sponsor
University of Indianapolis
Collaborators
Novacare, Midwestern University
1. Study Identification
Unique Protocol Identification Number
NCT02458391
Brief Title
Complete Decongestive Therapy in Breast Cancer-Related Lymphedema
Official Title
Therapeutic Quantity of Complete Decongestive Therapy in Breast Cancer-Related Lymphedema: A Double Blinded Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Withdrawn
Why Stopped
No participants available
Study Start Date
July 2015 (undefined)
Primary Completion Date
July 2015 (Anticipated)
Study Completion Date
July 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Indianapolis
Collaborators
Novacare, Midwestern University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to investigate which number of lymphedema therapy treatments/week best reduces upper extremity swelling, increased arm function, and reduces the most lymphedema symptoms.
Detailed Description
Complete Decongestive Therapy (CDT) is the "gold standard" in lymphedema care and has been found to be efficacious in numerous studies. These studies have varying treatment protocols of intensive phase I CDT with dosing ranging from 2x/wk for a mean of 7.5 wks to 6x/wk until a plateau in arm volumes were achieved. This variability in research does not lend itself to recommendations of evidence-based protocol use of CDT in an outpatient setting.
Although CDT is backed by efficacy studies, the daily dosing given to patients is based on anecdotal rather than evidence-based practice. Because the traditional protocol was developed from "longstanding experience," research is necessary to determine the best dosing of the intensive phase of CDT. The purpose of this study is to investigate what level of dosing in the intensive CDT phase promotes best volume reduction and increased upper extremity function in the breast cancer-related lymphedema patient population. This particular study will answer: What dosing produces best volumetric reduction and upper extremity function in the intensive phase of complete decongestive therapy for outpatients with breast cancer-related lymphedema 2x/wk for 4wks or 4x/wk for 4 wks?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphedema of Upper Limb
Keywords
Breast Cancer, Lymphedema
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment 2x/wk
Arm Type
Experimental
Arm Description
Participants will receive standard of care complete decongestive therapy 2x/wk for 4 weeks.
Arm Title
Treatment 4x/wk
Arm Type
Experimental
Arm Description
Participants will receive standard of care complete decongestive therapy 4x/wk for 4 weeks.
Intervention Type
Other
Intervention Name(s)
Standard of care complete decongestive therapy
Intervention Description
Participants will receive standard of care complete decongestive therapy consisting of meticulous skin and nail care, manual lymphatic drainage, compression bandaging, remedial exercises and self-care training.
Primary Outcome Measure Information:
Title
Change from baseline in impairments in function, activity limitations, and participation restrictions
Description
A questionnaire looking at impairments in function, activity limitations, and participation restrictions consists of 29 questions divided into five domains: physical function, mental function, household activities, mobility activities, and life and social activities.
Time Frame
At first treatment appointment (roughly week 1), after 4 weeks of treatment, at discharge (roughly after 8 weeks), and at a 4 week follow-up session after discharge (up to 12 weeks)
Title
Changes from baseline in symptoms associated with lymphedema
Description
This outcome measure will assess the presence of symptoms associated with lymphedema.
Time Frame
At first treatment appointment (week 1), after 4 weeks of treatment, at discharge (roughly after 8 weeks), and at a 4 week follow-up session after discharge (up to 12 weeks)
Secondary Outcome Measure Information:
Title
Changes from baseline in lymphedema volume
Description
Circumferential measurements by tape measure calculated into volume percentage
Time Frame
At first treatment appointment (week 1), after 4 weeks of treatment, at discharge (roughly after 8 weeks), and at a 4 week follow-up session after discharge (up to 12 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have active unilateral breast cancer-related lymphedema
Medically stable
Have not participated in lymphedema therapy the past 3 months
An affected limb volume measurement of >10% excess volume
Ages 18-95 years old
Patients undergoing any medical treatment for their breast cancer diagnosis will be included in this study.
Patients with any stage breast cancer will be included in this study.
Patients with a prior diagnosis of breast cancer, other cancer will be included in this study. There is no minimum time requirement that has prolapsed between their diagnosis and this study.
All subjects must have given signed, informed consent prior to registration on study.
Exclusion Criteria:
Prophylactic treatment indicated
A presence of upper extremity wounds present
Active signs of infection or deep vein thrombosis (DVT)
Bilateral lymphedema present
Evidence of contraindications to CDT: uncontrolled hypertension, heart disease including congestive heart failure, and renal insufficiency
Severe lymphedema present as defined by > 30% increase in limb volume
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Rundquist, PhD, PT
Organizational Affiliation
University of Indianapolis
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
Citation
Fu, M.R., Hu, S. Cleland, C.M. Kang, Y. (June, 29, 2012). Measuring lymphedema symptom burdens: A psychometric study. The Multinational Association of Supportive Care in Cancer's annual meeting (MASCC/ISOO): 2012 International Symposium on Supportive Care in Cancer in New York City on June 28-30, 2012.
Results Reference
result
PubMed Identifier
17684090
Citation
Mayrovitz HN, Macdonald J, Davey S, Olson K, Washington E. Measurement decisions for clinical assessment of limb volume changes in patients with bilateral and unilateral limb edema. Phys Ther. 2007 Oct;87(10):1362-8. doi: 10.2522/ptj.20060382. Epub 2007 Aug 7.
Results Reference
result
PubMed Identifier
16445334
Citation
Taylor R, Jayasinghe UW, Koelmeyer L, Ung O, Boyages J. Reliability and validity of arm volume measurements for assessment of lymphedema. Phys Ther. 2006 Feb;86(2):205-14.
Results Reference
result
PubMed Identifier
21493748
Citation
Devoogdt N, Van Kampen M, Geraerts I, Coremans T, Christiaens MR. Lymphoedema Functioning, Disability and Health questionnaire (Lymph-ICF): reliability and validity. Phys Ther. 2011 Jun;91(6):944-57. doi: 10.2522/ptj.20100087. Epub 2011 Apr 14.
Results Reference
result
Learn more about this trial
Complete Decongestive Therapy in Breast Cancer-Related Lymphedema
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