Complete Decongestive Therapy in Breast Cancer-Related Lymphedema

Therapeutic Quantity of Complete Decongestive Therapy in Breast Cancer-Related Lymphedema: A Double Blinded Randomized Control Trial

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.

Study Overview

• Status: Withdrawn
• Conditions: Lymphedema of Upper Limb
• Intervention / Treatment: Other: Standard of care complete decongestive therapy

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?

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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)
Changes from baseline in symptoms associated with lymphedema	This outcome measure will assess the presence of symptoms associated with lymphedema.	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 Measures

Outcome Measure	Measure Description	Time Frame
Changes from baseline in lymphedema volume	Circumferential measurements by tape measure calculated into volume percentage	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)

Collaborators and Investigators

• Sponsor: University of Indianapolis
• Collaborators: Novacare; Midwestern University
• Investigators: Principal Investigator: Peter Rundquist, PhD, PT, University of Indianapolis

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Anticipated): July 1, 2015
• Study Completion (Anticipated): July 1, 2015

Study Registration Dates

• First Submitted: November 17, 2014
• First Submitted That Met QC Criteria: May 27, 2015
• First Posted (Estimate): June 1, 2015

Study Record Updates

• Last Update Posted (Actual): October 24, 2018
• Last Update Submitted That Met QC Criteria: October 23, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Lymphedema; Breast Cancer
• Additional Relevant MeSH Terms: Pathologic Processes; Lymphatic Diseases; Postoperative Complications; Lymphedema; Breast Cancer Lymphedema
• Other Study ID Numbers: UIndianapolis

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No