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

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 45 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-11-30

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.

Conditions

Breast Cancer; Lymphedema

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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

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

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

Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Tel Aviv Medical Center

Tel Aviv, , Israel

Countries

Israel

Central Contacts

Ruthi Peleg, BPT

Role: CONTACT

ruthiwolff@gmail.com

+97236973104

Other Identifiers

TASMC-12-EG-449-CTIL

Identifier Type: -

Identifier Source: org_study_id