Complete Decongestive Therapy in Breast Cancer-Related Lymphedema

NCT02458391 | Withdrawn DMC

• 1 other identifier: UIndianapolis
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lymphedema of Upper Limb

Keywords

Breast Cancer; Lymphedema

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Changes from baseline in lymphedema volume

  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)

Study Arms (2)

Treatment 2x/wk

EXPERIMENTAL

Participants will receive standard of care complete decongestive therapy 2x/wk for 4 weeks.

Other: Standard of care complete decongestive therapy

Treatment 4x/wk

EXPERIMENTAL

Participants will receive standard of care complete decongestive therapy 4x/wk for 4 weeks.

Other: Standard of care complete decongestive therapy

Interventions

Standard of care complete decongestive therapy OTHER

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.

Treatment 2x/wk; Treatment 4x/wk

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Indianapolis: lead
• Novacare: collaborator
• Midwestern University: collaborator

Related Publications (4)

• 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.

  RESULT

• 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.

  PMID: 17684090 RESULT

• 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.

  PMID: 16445334 RESULT

• 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.

  PMID: 21493748 RESULT

MeSH Terms

Conditions

Breast Neoplasms; Lymphedema

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Peter Rundquist, PhD, PT

  University of Indianapolis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sponsor Investigator

Study Record Dates

• First Submitted: November 17, 2014
• First Posted: June 1, 2015
• Study Start: July 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: October 24, 2018

Record last verified: 2018-10