NCT00935714

Brief Summary

Arm exercise influences arm volume and symptoms in breast cancer related lymphedema.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

July 8, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 9, 2009

Completed
23 days until next milestone

Study Start

First participant enrolled

August 1, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Last Updated

August 19, 2009

Status Verified

August 1, 2009

Enrollment Period

5 months

First QC Date

July 8, 2009

Last Update Submit

August 18, 2009

Conditions

Breast CancerLymphedema

Keywords

ArmLymphedemaBreast CancerExerciseBreast Cancer related Lymphedema

Outcome Measures

Primary Outcomes (1)

  • Improved arm volume measurement

    Weekly for five weeks

Secondary Outcomes (1)

  • Quality of Life

    Weekly for 5 weeks

Study Arms (2)

Muscle Group

ACTIVE COMPARATOR

Exercise

Other: Exercise

Sequence

ACTIVE COMPARATOR

Exercise

Other: Exercise

Interventions

ExerciseOTHER
Muscle Group

Eligibility Criteria

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

You may qualify if:

  • unilateral arm lymphedema as a result of breast cancer treatment
  • completion of breast cancer treatments
  • arm lymphedema onset 3 months or more after surgery and persistent for at least 6 months
  • in the maintenance phase of lymphedema treatment

You may not qualify if:

  • women with recurrent cancer
  • intercurrent diseases affecting the swollen arm
  • lack of understanding of the Hebrew language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe Medical Center

Hadera, 38100, Israel

RECRUITING

MeSH Terms

Conditions

Breast NeoplasmsLymphedemaMotor ActivityBreast Cancer Lymphedema

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesLymphatic DiseasesHemic and Lymphatic DiseasesBehaviorPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Jillian H Bracha, BSc

CONTACT

972-523784551gillianb@hy.health.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

July 8, 2009

First Posted

July 9, 2009

Study Start

August 1, 2009

Primary Completion

January 1, 2010

Last Updated

August 19, 2009

Record last verified: 2009-08

Locations

IL(1)