Complete Decongestive Therapy in Breast Cancer-Related Lymphedema

University of Indianapolis

Status: Withdrawn

Conditions: Lymphedema of Upper Limb

Treatments: Other: Standard of care complete decongestive therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02458391

UIndianapolis

Details and patient eligibility

About

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.

Full 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?

Sex: All

Ages: 18 to 95 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

Treatment 2x/wk

Experimental group

Description:

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

Treatment:

Other: Standard of care complete decongestive therapy

Treatment 4x/wk

Experimental group

Description:

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

Treatment:

Other: Standard of care complete decongestive therapy