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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01672125
First received: August 21, 2012
Last updated: August 23, 2012
Last verified: August 2012
  Purpose

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


Condition Intervention
Breast Cancer
Lymphedema
Other: circumferential measurements in different upper limb positions.

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Effect of Upper Limb Posture on Limb Volume as Expressed in Circumference Measurement in Healthy Women and in Women With Breast Cancer Related Lymphedema

Resource links provided by NLM:


Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • Circumferential upper limb measurement [ Time Frame: 3 hours for each subject ] [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: November 2012
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01672125

Contacts
Contact: Ruthi Peleg, BPT +97236973104 ruthiwolff@gmail.com

Locations
Israel
Tel Aviv Medical Center Not yet recruiting
Tel Aviv, Israel, 64239
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
  More Information

No publications provided

Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01672125     History of Changes
Other Study ID Numbers: TASMC-12-EG-449-CTIL
Study First Received: August 21, 2012
Last Updated: August 23, 2012
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Breast Neoplasms
Lymphedema
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Lymphatic Diseases

ClinicalTrials.gov processed this record on October 01, 2014