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

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

Study Overview

• Status: Unknown
• Conditions: Breast Cancer; Lymphedema
• Intervention / Treatment: Other: circumferential measurements in different upper limb positions.

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 Type: Observational
• Enrollment (Anticipated): 45

Contacts and Locations

Study Locations

• Israel
  • Tel Aviv, Israel, 64239
    • Tel Aviv Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

women who have completed breast cancer treatments, with a diagnosis of unilateral arm lymphedema, in the intensive phase and in the maintenance phase of lymphedema treatment, 15 healthy women adjusted in age and BMI.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Other: circumferential measurements in different upper limb positions.; 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	Other: circumferential measurements in different upper limb positions.; circumferential measurements in different upper limb positions, in 90 degrees forward flexion and depending position
healthy women; healthy women adjusted in age and BMI	Other: circumferential measurements in different upper limb positions.; circumferential measurements in different upper limb positions, in 90 degrees forward flexion and depending position

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Circumferential upper limb measurement	3 hours for each subject

Collaborators and Investigators

• Sponsor: Tel-Aviv Sourasky Medical Center

Study record dates

Study Major Dates

• Study Start: November 1, 2012

Study Registration Dates

• First Submitted: August 21, 2012
• First Submitted That Met QC Criteria: August 23, 2012
• First Posted (Estimate): August 24, 2012

Study Record Updates

• Last Update Posted (Estimate): August 24, 2012
• Last Update Submitted That Met QC Criteria: August 23, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Neoplasms; Lymphatic Diseases; Neoplasms by Site; Postoperative Complications; Breast Diseases; Breast Neoplasms; Lymphedema; Breast Cancer Lymphedema
• Other Study ID Numbers: TASMC-12-EG-449-CTIL