NCT00058851

Brief Summary

The purpose of this study is to examine the short-term and long-term efficacy of massage therapy alone compared to massage therapy plus compression bandaging in the treatment of breast cancer treatment-related swelling of the arms and legs.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2003

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 14, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 15, 2003

Completed
4.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

August 19, 2009

Status Verified

August 1, 2009

First QC Date

April 14, 2003

Last Update Submit

August 17, 2009

Conditions

Lymphedema

Keywords

Manual lymph drainageCombined physiotherapy

Outcome Measures

Primary Outcomes (1)

  • volume change

Interventions

Manual lymph drainagePROCEDURE
Combined physiotherapyPROCEDURE
Compression bandagingPROCEDURE

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Lymphedema (5% to 20% increase in volume) after breast cancer treatment

You may not qualify if:

  • Physically unable to perform massage or bandaging during home program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arizona

Tucson, Arizona, 85724, United States

Location

MeSH Terms

Conditions

Lymphedema

Interventions

Manual Lymphatic DrainageCompression Bandages

Condition Hierarchy (Ancestors)

Lymphatic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

MassageTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsDrainagePhysical Therapy ModalitiesRehabilitationBandagesEquipment and Supplies

Study Officials

  • Michael J Bernas, MS

    University of Arizona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

April 14, 2003

First Posted

April 15, 2003

Study Start

January 1, 2003

Study Completion

November 1, 2007

Last Updated

August 19, 2009

Record last verified: 2009-08

Locations

US(1)