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Complete Decongestive Therapy in Breast Cancer-Related Lymphedema

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ClinicalTrials.gov Identifier: NCT02458391
Recruitment Status : Withdrawn (No participants available)
First Posted : June 1, 2015
Last Update Posted : October 24, 2018
Sponsor:
Collaborators:
Novacare
Midwestern University
Information provided by (Responsible Party):
Katie M. Polo, MHS, OTR/L, CLT-LANA, University of Indianapolis

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.

Condition or disease Intervention/treatment Phase
Lymphedema of Upper Limb Other: Standard of care complete decongestive therapy Not Applicable

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?


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Therapeutic Quantity of Complete Decongestive Therapy in Breast Cancer-Related Lymphedema: A Double Blinded Randomized Control Trial
Study Start Date : July 2015
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphedema

Arm Intervention/treatment
Experimental: Treatment 2x/wk
Participants will receive standard of care complete decongestive therapy 2x/wk for 4 weeks.
Other: Standard of care complete decongestive therapy
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.

Experimental: Treatment 4x/wk
Participants will receive standard of care complete decongestive therapy 4x/wk for 4 weeks.
Other: Standard of care complete decongestive therapy
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 Measures :
  1. Change from baseline in impairments in function, activity limitations, and participation restrictions [ 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) ]
    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.

  2. Changes from baseline in 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) ]
    This outcome measure will assess the presence of symptoms associated with lymphedema.


Secondary Outcome Measures :
  1. Changes from baseline in lymphedema volume [ 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) ]
    Circumferential measurements by tape measure calculated into volume percentage



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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02458391


Sponsors and Collaborators
University of Indianapolis
Novacare
Midwestern University
Investigators
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Principal Investigator: Peter Rundquist, PhD, PT University of Indianapolis

Publications of Results:
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Responsible Party: Katie M. Polo, MHS, OTR/L, CLT-LANA, Sponsor Investigator, University of Indianapolis
ClinicalTrials.gov Identifier: NCT02458391     History of Changes
Other Study ID Numbers: UIndianapolis
First Posted: June 1, 2015    Key Record Dates
Last Update Posted: October 24, 2018
Last Verified: October 2018

Keywords provided by Katie M. Polo, MHS, OTR/L, CLT-LANA, University of Indianapolis:
Breast Cancer
Lymphedema

Additional relevant MeSH terms:
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Breast Neoplasms
Lymphedema
Breast Cancer Lymphedema
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Lymphatic Diseases
Postoperative Complications
Pathologic Processes