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Breast Cancer | Effect of Upper Limb Posture on Limb Volume as Expressed in Circumference Measurement in Healthy Women and in Women With Breast Cancer Related Lymphedema

Breast Cancer research study

What is the primary objective of this study?

Lymphedema is one side effect of breast cancer treatment. Measuring the edematous limb enables monitoring changes in the lymphedema and the effect of treatment. Circumference measurement using a measuring tape is an inexpensive simple method and therefore useful and widespread in clinical practice. Circumference measurement performance varies amongst therapists and lacks uniformity in the literature. To date, the effect of different limb positions on measurement results has not been examined. Purpose: The purpose of this study is to describe 1) the effect of position on upper limb volume measurement by using circumference measurement and 2) to examine whether the difference between positions are similar in the upper limbs of the same woman, and 3) between groups of women who are in the intensive phase, in the maintenance phase of lymphedema treatment and women without lymphedema

Who is eligible to participate?

Inclusion Criteria: - 15 women who have completed breast cancer treatments, with a diagnosis of unilateral arm lymphedema, in the intensive phase of lymphedema treatment; - 15 women who have completed breast cancer treatment and are in the maintenance phase of lymph edema treatment and - 15 healthy women adjusted in age and BMI. Exclusion Criteria: - active cancer, - cardiovascular disorder, - wounds or inflammation in the measured upper limb, and - illness with fever.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Breast Cancer

Lymphedema

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Other:circumferential measurements in different upper limb positions.circumferential measurements in different upper limb positions, in 90 degrees forward flexion and depending position

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

women who have completed treatmentswomen who have completed breast cancer treatments, with a diagnosis of unilateral arm lymphedema, in the intensive phase of lymphedema treatment

women who have completed treatment in maintenance phasewomen who have completed breast cancer treatment and are in the maintenance phase of lymph edema treatment

healthy womenhealthy women adjusted in age and BMI

Study Status

Unknown status

Start Date: November 2012

Completed Date:

Phase:

Type: Observational

Design:

Primary Outcome: Circumferential upper limb measurement

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator:

Lead Sponsor: Tel-Aviv Sourasky Medical Center

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01672125

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