Breast CancerNCT01672125
Effect of Upper Limb Posture on Limb Volume as Expressed in Circumference Measurement in Healthy Women and in Women With Breast Cancer Related Lymphedema
An observational study of Breast Cancer and Lymphedema, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Lymphedema
- What is being tested?
- circumferential measurements in different upper limb positions.
- How many people
- 45 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2012to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- active cancer,
- cardiovascular disorder,
- wounds or inflammation in the measured upper limb, and
- illness with fever.
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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
- Being tested
- circumferential measurements in different upper limb positions.
- Medical subject headings
- Breast Neoplasms, Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
circumferential measurements in different upper limb positions.Other
circumferential measurements in different upper limb positions, in 90 degrees forward flexion and depending position
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: circumferential measurements in different upper limb positions. | |
| 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 Receives: Other: circumferential measurements in different upper limb positions. | |
| healthy women | healthy women adjusted in age and BMI Receives: Other: circumferential measurements in different upper limb positions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Circumferential upper limb measurement
Measured: 3 hours for each subject
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2012 (estimated)
- Study startNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01672125
- Sponsor's protocol ID
- TASMC-12-EG-449-CTIL
- Status last verified
- Aug 2012
- First submitted
- 21 Aug 2012
- Last updated
- 24 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01672125
- Acronym / sponsor ID
- TASMC-12-EG-449-CTIL
- Conditions
- Breast Cancer, Lymphedema
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Nov 2012
- First posted
- 24 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| women who have completed treatments | – | Other: 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 |
| women who have completed treatment in maintenance phase | – | Other: 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 | – | Other: circumferential measurements in different upper limb positions.healthy women adjusted in age and BMI |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- active cancer,
- cardiovascular disorder,
- wounds or inflammation in the measured upper limb, and
- illness with fever.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| circumferential measurements in different upper limb positions.circumferential measurements in different upper limb positions, in 90 degrees forward flexion and depending position | Other | healthy women, women who have completed treatment in maintenance phase, women who have completed treatments |
Primary outcome
Circumferential upper limb measurement
Time frame: 3 hours for each subject
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Lymphedema, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ruthi Peleg, BPT (+97236973104, ruthiwolff@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Circumferential upper limb measurement (time frame: 3 hours for each subject). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2012.