Clinical trial · Interventional

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

NCT02458391CI-TRIAL-00035422withdrawnN/AClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Why stopped (as posted): No participants available

Summary

Brief summary (as posted)

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

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Lymphedema of Upper Limb	—	UNRESOLVED	—

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Standard of care complete decongestive therapy	Other	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
Treatment 2x/wk
description
Participants will receive standard of care complete decongestive therapy 2x/wk for 4 weeks.
interventionNames
1. Other: Standard of care complete decongestive therapy
type
EXPERIMENTAL
label
Treatment 4x/wk
description
Participants will receive standard of care complete decongestive therapy 4x/wk for 4 weeks.
interventionNames
1. Other: Standard of care complete decongestive therapy

Primary outcomes (2)

measure
Change from baseline in impairments in function, activity limitations, and participation restrictions
timeFrame

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 95 Years

Show eligibility criteria text

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

References

Publications (4)

RESULTFu, 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.
RESULTMayrovitz 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
RESULTTaylor 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
RESULTDevoogdt 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