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

NCT ID: NCT01672125

Last Updated: 2012-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-11-30

Brief Summary

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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

Detailed Description

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Study design: Analytical cross section study Population: 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.

Research tools: Questionnaire to gather personal details, information about the cancer and the lymphedema. Plastic, retractable measuring tape with an accuracy of 1 mm. Fixed points on the limb are measured according to anatomical landmarks and afterwards the limb volume is calculated using the formula for a truncated cone.

Conditions

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Breast Cancer Lymphedema

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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women who have completed treatments

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

circumferential measurements in different upper limb positions.

Intervention Type OTHER

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

women who have completed treatment in maintenance phase

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

circumferential measurements in different upper limb positions.

Intervention Type OTHER

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

healthy women

healthy women adjusted in age and BMI

circumferential measurements in different upper limb positions.

Intervention Type OTHER

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

Interventions

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circumferential measurements in different upper limb positions.

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Tel Aviv Medical Center

Tel Aviv, , Israel

Site Status

Countries

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Israel

Central Contacts

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Ruthi Peleg, BPT

Role: CONTACT

Phone: +97236973104

Email: [email protected]

Other Identifiers

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TASMC-12-EG-449-CTIL

Identifier Type: -

Identifier Source: org_study_id