NCT00951067

Brief Summary

The purpose of this study is to determine how well different treatments for acquired lymphedema work. The study will compare 5 different non-invasive treatments for acquired lymphedema of the arm to see which treats lymphedema best.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 4, 2009

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

January 31, 2014

Status Verified

January 1, 2014

Enrollment Period

4.5 years

First QC Date

August 3, 2009

Last Update Submit

January 30, 2014

Conditions

Lymphedema

Keywords

LymphedemaBreast CancerUpper ExtremityArm

Outcome Measures

Primary Outcomes (1)

  • Arm Volume

    Arm volume will be measured at 2 weeks before treatment starts, day treatment begins, and then 1 month, 3 months, 6 months, and 7 months after treatment starts

Secondary Outcomes (2)

  • Infection (cellulitis)

    Presence of infection will be recorded at 2 weeks before treatment starts, day treatment begins, and then 1 month, 3 months, 6 months, and 7 months after treatment starts

  • Quality of Life Survey

    Survey will be given at 2 weeks before treatment starts, day treatment begins, and then 1 month, 3 months, 6 months, and 7 months after treatment starts

Study Arms (5)

Group A

ACTIVE COMPARATOR

Exercise, Elevation, and Garment Compression

Other: Exercise, Elevation, and Compression Garment

Group B

ACTIVE COMPARATOR

Pneumatic Compression Device (B)

Device: E0650 PCD with non-sequential waveform

Group C

ACTIVE COMPARATOR

Pneumatic Compression Device (C)

Device: E0651 PCD with sequential, non-gradient waveform

Group D

ACTIVE COMPARATOR

Pneumatic Compression Device (D)

Device: E0652 PCD with sequential, gradient waveform

Group E

ACTIVE COMPARATOR

Pneumatic Compression Device (E)

Device: E0652 PCD with peristaltic pulse waveform

Interventions

Exercise, Elevation, and Compression GarmentOTHER

Patients will be asked to daily: * exercise * elevate arm * wear an arm compression garment

Group A
E0650 PCD with non-sequential waveformDEVICE

Use of an E0650 PCD with non-sequential waveform for two hours every day.

Also known as: Brand: Huntleigh Flowtron Hydroven™ 3
Group B
E0651 PCD with sequential, non-gradient waveformDEVICE

Use of an E0651 PCD with sequential, non-gradient waveform for two hours every day

Also known as: Brand: Petite Basic System (Model 701A) Lympha Press
Group C
E0652 PCD with sequential, gradient waveformDEVICE

Use of an E0652 PCD with sequential, gradient waveform for two hours every day.

Also known as: Brand: Bio Compression Sequential Circulator 3008
Group D
E0652 PCD with peristaltic pulse waveformDEVICE

Use the E0652 PCD with peristaltic pulse waveform for two hours every day.

Also known as: NormaTec brand
Group E

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with acquired lymphedema of the arm.

You may not qualify if:

  • Refusal of consent
  • Unlikely compliance with the research protocol
  • Acute upper extremity DVT

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Boston at Waltham

Waltham, Massachusetts, 02453, United States

Location

MeSH Terms

Conditions

LymphedemaBreast Neoplasms

Interventions

Exercise

Condition Hierarchy (Ancestors)

Lymphatic DiseasesHemic and Lymphatic DiseasesNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Arin K Greene, MD, MMSc

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2009

First Posted

August 4, 2009

Study Start

August 1, 2009

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

January 31, 2014

Record last verified: 2014-01

Locations

US(1)