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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Withdrawn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
University of Indianapolis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphedema of Upper Limb focused on measuring Breast Cancer, Lymphedema

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Have active unilateral breast cancer-related lymphedema
  2. Medically stable
  3. Have not participated in lymphedema therapy the past 3 months
  4. An affected limb volume measurement of >10% excess volume
  5. 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:

  1. Prophylactic treatment indicated
  2. A presence of upper extremity wounds present
  3. Active signs of infection or deep vein thrombosis (DVT)
  4. Bilateral lymphedema present
  5. Evidence of contraindications to CDT: uncontrolled hypertension, heart disease including congestive heart failure, and renal insufficiency
  6. 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

    First Posted
    November 17, 2014
    Last Updated
    October 23, 2018
    Sponsor
    University of Indianapolis
    Collaborators
    Novacare, Midwestern University
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    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

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    Complete Decongestive Therapy in Breast Cancer-Related Lymphedema

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