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

• Conditions: Breast Cancer; Lymphedema
• Interventions: Other: circumferential measurements in different upper limb positions.

• Registration Number: NCT01672125
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

Brief Summary

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

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.

Study Timeline

• Status Verified: 2012-08
• Study First Submitted: 2012-08-21
• Study First Submitted QC: 2012-08-23
• Last Update Submitted: 2012-08-23
• Study First Posted: 2012-08-24
• Last Update Posted: 2012-08-24
• Study Start: 2012-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 45

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
women who have completed treatment in maintenance phase	circumferential measurements in different upper limb positions.	women who have completed breast cancer treatment and are in the maintenance phase of lymph edema treatment
healthy women	circumferential measurements in different upper limb positions.	healthy women adjusted in age and BMI
women who have completed treatments	circumferential measurements in different upper limb positions.	women who have completed breast cancer treatments, with a diagnosis of unilateral arm lymphedema, in the intensive phase of lymphedema treatment

Primary Outcome Measures

Name	Time	Method
Circumferential upper limb measurement	3 hours for each subject

Trial Locations

Locations (1)

Tel Aviv Medical Center; 🇮🇱 Tel Aviv, Israel