Breast CancerNCT01969253
A Prospective Observational Study of Lymphedema in Breast Cancer With Axillary Lymph Node Dissection
An observational study of Breast Cancer, run by National Cancer Center, Korea at 1 site in South Korea.
Trial summary
Over the past few years, several studies have been made on various outcomes about the incidence of lymphedema. Because the outcomes can be came out differently each study by measurement, criteria, treatment period, treatment method and morbid extremities of lymphedema. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 400 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2012to Dec 2013
- 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 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: This prospective study is observational study that focused on incidence of lymphedema in breast cancer patients. Annually six hundred patients have received treatment of breast cancer from the breast cancer center at National Cancer Center in Korea. Among of them, two hundred patients have received surgical treatment with axillary dissection. About four hundred patients were recruited consecutively for enrollment from May 2012 to December 2013.
Who may be able to join
- Older than 20 years old
- Patient who underwent unilateral Breast Cancer surgery with ALND
- Informed consent must to be signed
Who cannot join
- Previous history of breast cancer
- History of abnormality or vascular disease in upper extremity
- Patients with other serious systemic illness (renal failure, hepatic dysfunction, congestive heart failure, neurological or psychological impairment) that would confound the study or impair the patients' ability to participate.
- History of infection on upper extremity
- History of corticosteroid use on whole body for any reason
- Inability to provide informed consent (e.g. dementia or severe cognitive impairment)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Observational Study of Lymphedema in Breast Cancer With Axillary Lymph Node Dissection (ALND)
Over the past few years, several studies have been made on various outcomes about the incidence of lymphedema. Because the outcomes can be came out differently each study by measurement, criteria, treatment period, treatment method and morbid extremities of lymphedema. Therefore it is required for understanding about the incidence, risk factor and physical progress for to be treated and prevented of lymphedema. Also it is necessary that to understand characteristics of lymphedema measurements and to establish diagnostic criteria of lymphedema through comparative study.
The aim of this study was to analyze the incidence and risk factor of lymphedema through prospectively observation, and to determine effects on the quality of life of lymphedema after breast cancer surgery with ALND.
Read the detailed description
Primary Objectives:
- To analyze incidence rate of lymphedema using tape measurements, perometre, bioimpedance, spectroscopy.
Secondary Objectives:
- To determine the risk factor of lymphedema in postoperative breast cancer.
- To understand that lymphedema has an effect on quality of life and physical function in postoperative breast cancer.
- To complete uestionnaire about physical and quality of life in postoperative breast cancer with ALND patients.
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Axillary Lymph Node Dissection, Lymphedema
- Medical subject headings
- Breast Neoplasms, Lymphedema
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the incidence of lymphedema in upper arm after ALND
In this study, we evaluated the incidence of lymphedema in upper arm using tape measurement, perometre and bioimpedance spectroscopy during pre,post-operative visit, 3, 6, 9month and 1year clinical follow-up.
Measured: Up to 1year
Secondary outcomes (2)
To Evaluate quality of life using questionnaire
- European Organization for Research and Treatment of Cancer(EORTC) the 30-item version of the core Quality of Life Questionnaire (EORTC QLQ C30)
- EORTC Quality of Life Questionnaire - Breast Cancer Module (EORTC QLQ BR23)
Measured: Up to 1year
Physical assess
- Questionnaire: Disabilities of the arm shoulder and hand using (DASH)
- Physical examination
Measured: Up to 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2013 (estimated)
- Study startMay 2012
- Primary completionDec 2013
- Study completionDec 2013
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Responsible party
- Principal investigator, So-Youn Jung, National Cancer Center, Korea
- Investigators
- So-Youn Jung, Principal investigator, National Cancer Center, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01969253
- Sponsor's protocol ID
- NCC-1210181-2
- Status last verified
- Oct 2015
- First submitted
- 14 Aug 2013
- Last updated
- 15 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study of Lymphedema in Breast Cancer With Axillary Lymph Node Dissection (ALND)
- ClinicalTrials.gov ID
- NCT01969253
- Acronym / sponsor ID
- NCC-1210181-2
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Axillary Lymph Node Dissection, Lymphedema
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- May 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 25 Oct 2013 (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.
Over the past few years, several studies have been made on various outcomes about the incidence of lymphedema. Because the outcomes can be came out differently each study by measurement, criteria, treatment period, treatment method and morbid extremities of lymphedema. Therefore it is required for understanding about the incidence, risk factor and physical progress for to be treated and prevented of lymphedema. Also it is necessary that to understand characteristics of lymphedema measurements and to establish diagnostic criteria of lymphedema through comparative study.
The aim of this study was to analyze the incidence and risk factor of lymphedema through prospectively observation, and to determine effects on the quality of life of lymphedema after breast cancer surgery with ALND.
Detailed description
Primary Objectives:
- To analyze incidence rate of lymphedema using tape measurements, perometre, bioimpedance, spectroscopy.
Secondary Objectives:
- To determine the risk factor of lymphedema in postoperative breast cancer.
- To understand that lymphedema has an effect on quality of life and physical function in postoperative breast cancer.
- To complete uestionnaire about physical and quality of life in postoperative breast cancer with ALND patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This prospective study is observational study that focused on incidence of lymphedema in breast cancer patients. Annually six hundred patients have received treatment of breast cancer from the breast cancer center at National Cancer Center in Korea. Among of them, two hundred patients have received surgical treatment with axillary dissection. About four hundred patients were recruited consecutively for enrollment from May 2012 to December 2013.
Key inclusion criteria (3 listed)
- Older than 20 years old
- Patient who underwent unilateral Breast Cancer surgery with ALND
- Informed consent must to be signed
Key exclusion criteria (6 listed)
- Previous history of breast cancer
- History of abnormality or vascular disease in upper extremity
- Patients with other serious systemic illness (renal failure, hepatic dysfunction, congestive heart failure, neurological or psychological impairment) that would confound the study or impair the patients' ability to participate.
- History of infection on upper extremity
- History of corticosteroid use on whole body for any reason
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To evaluate the incidence of lymphedema in upper arm after ALND
Time frame: Up to 1year
In this study, we evaluated the incidence of lymphedema in upper arm using tape measurement, perometre and bioimpedance spectroscopy during pre,post-operative visit, 3, 6, 9month and 1year clinical follow-up.
2 secondary outcomes
To Evaluate quality of life using questionnaire
Time frame: Up to 1year
Physical assess
Time frame: Up to 1year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2015.
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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.
So-Youn Jung principal investigator
National Cancer Center, Korea
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, run by National Cancer Center, Korea at 1 site in South Korea.
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 6 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: finished, as of the sponsor's last update on 15 Oct 2015. 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the incidence of lymphedema in upper arm after ALND (time frame: Up to 1year). 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 15 Oct 2015.