Breast CancerNCT01427166
Non-Invasive Imaging for Cording in Breast Cancer Patients
A study testing Non invasive venous ultrasound in people with Breast Cancer, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
To date, the scientific literature has yet to provide sufficient evidence regarding the pathophysiology of cording. The objective of this protocol is to evaluate the utility of non invasive vascular imaging for assessing the pathophysiology of cording in a small study cohort of patients who were treated for breast… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Non invasive venous ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Aug 2012
- Phase
- Interventional
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must be enrolled in Partners protocol # 2008P000540 "Prospective Analysis of Symptoms, Functionality and Quality of Life Questionnaires to Evaluate Lymphedema in Patients Following Treatment for Breast Cancer"
- Confirmed case of cording by a medical provider (Physician, Nurse Practitioner, Physician Assistant)
- Participants must be at least 18 years of age
- Life expectancy of greater than 1 year.
- Ability to understand and the willingness to sign a written informed consent document.
- Willingness to comply with required follow up Perometer measurements and clinical visits.
Who cannot join
- Participants who are not enrolled or have been removed from Partners Protocol # 2008P000540 will be excluded from this trial.
- Participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- History of prior surgery or radiation to the head, neck, upper limb, or trunk.
- Patients with a history of a different malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Evaluation of Non Invasive Imaging for Assessing the Pathophysiology of Cording in Patients Treated for Breast Cancer
To date, the scientific literature has yet to provide sufficient evidence regarding the pathophysiology of cording. The objective of this protocol is to evaluate the utility of non invasive vascular imaging for assessing the pathophysiology of cording in a small study cohort of patients who were treated for breast cancer. The hypothesis is that cording may have a vascular etiology
Read the detailed description
Cords are bands of tissue that are present in the axilla following breast cancer surgery and may extend across the antecubital fossa and into the forearm. Cords are often painful to patients and limit their shoulder range of motion.The proposed study design involves the recruitment of patients who are enrolled in Partners Protocol # 2008P000540, a prospective analysis of symptoms, functionality and quality of life questionnaire to evaluate lymphedema in patients following treatment for breast cancer. This protocol recruits newly diagnosed breast cancer patients prior to any treatment interventions. Subjects are required to undergo volumetric arm measurements and complete the Lymphedema Evaluation Following Treatment for Breast Cancer Questionnaire (LEFT-BC) which will allow for the evaluation of changes in functionality, upper extremity utilization (fear associated avoidance), and quality of life. Throughout treatment patients will be screened before and after each treatment event: surgery, chemotherapy and radiation. Following the conclusion of treatment for breast cancer, patients will be measured at least 2 times per year (every 4-7 months). If during these study visits the patient notes cording symptoms, the research staff administering the questionnaire will be alerted. At this point, they will notify a designated medical provider who will perform a physical examination of the area to confirm the presence of cording. Once the presence of cording is verified, the patient will be provided with the opportunity to enroll in the proposed trial. Due to the current limited knowledge on the nature of the condition, the patients arm and axilla will have to be imaged within 7 days of the physical exam confirmation. The patients will be asked to return to the vascular imaging lab located on the Massachusetts's General Hospital's main campus. They will undergo a venous duplex ultrasound, on a General Electric LOGIQ-9 unit with a Phillips-IU-22 probe.
- Conditions
- Breast Cancer
- Being tested
- Non invasive venous ultrasound
- Keywords
- Breast Cancer, Cording, Lymphedema, upper extremity cording, following treatment
- 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.
Non invasive venous ultrasoundOther
Subjects will undergo a venous duplex ultrasound, on a General Electric LOGIQ-9 unit with a Phillips-IU-22 probe
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound imaging | Experimental | Cords that are present in the participant's axilla and/or arm will be imaged with an ultrasound Receives: Other: Non invasive venous ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
The pathophysiology of cording following treatment for breast cancer
The cohort of 15 subject's images will be reviewed by the PI and a designated physician from the department of vascular medicine to determine if there is a vascular origin in the cords. Each image will be accessed for the following findings or involvement: Venous, lymphatic, fluid pockets, and striations on the cord.
Measured: 7 days
Secondary outcomes (1)
Cording and the onset of breast cancer related lymphedema
Subjects will be measured every 4-7 months with a perometer to determine if breast cancer related lymphedema is present.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2011 (estimated)
- Study startAug 2011
- Primary completionAug 2012
- Study completionAug 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.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Alphonse Taghian, MD, PhD, Massachusetts General Hospital
- Investigators
- Alphonse G Taghian, MD PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01427166
- Sponsor's protocol ID
- 10-279
- Other IDs
- R01CA139118
- Status last verified
- Mar 2016
- First submitted
- 25 Aug 2011
- Last updated
- 16 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Non Invasive Imaging for Assessing the Pathophysiology of Cording in Patients Treated for Breast Cancer
- ClinicalTrials.gov ID
- NCT01427166
- Acronym / sponsor ID
- 10-279
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Cording, Lymphedema, upper extremity cording, following treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 1 Sep 2011 (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.
To date, the scientific literature has yet to provide sufficient evidence regarding the pathophysiology of cording. The objective of this protocol is to evaluate the utility of non invasive vascular imaging for assessing the pathophysiology of cording in a small study cohort of patients who were treated for breast cancer. The hypothesis is that cording may have a vascular etiology
Detailed description
Cords are bands of tissue that are present in the axilla following breast cancer surgery and may extend across the antecubital fossa and into the forearm. Cords are often painful to patients and limit their shoulder range of motion.The proposed study design involves the recruitment of patients who are enrolled in Partners Protocol # 2008P000540, a prospective analysis of symptoms, functionality and quality of life questionnaire to evaluate lymphedema in patients following treatment for breast cancer. This protocol recruits newly diagnosed breast cancer patients prior to any treatment interventions. Subjects are required to undergo volumetric arm measurements and complete the Lymphedema Evaluation Following Treatment for Breast Cancer Questionnaire (LEFT-BC) which will allow for the evaluation of changes in functionality, upper extremity utilization (fear associated avoidance), and quality of life. Throughout treatment patients will be screened before and after each treatment event: surgery, chemotherapy and radiation. Following the conclusion of treatment for breast cancer, patients will be measured at least 2 times per year (every 4-7 months). If during these study visits the patient notes cording symptoms, the research staff administering the questionnaire will be alerted. At this point, they will notify a designated medical provider who will perform a physical examination of the area to confirm the presence of cording. Once the presence of cording is verified, the patient will be provided with the opportunity to enroll in the proposed trial. Due to the current limited knowledge on the nature of the condition, the patients arm and axilla will have to be imaged within 7 days of the physical exam confirmation. The patients will be asked to return to the vascular imaging lab located on the Massachusetts's General Hospital's main campus. They will undergo a venous duplex ultrasound, on a General Electric LOGIQ-9 unit with a Phillips-IU-22 probe.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultrasound imaging | Experimental | Other: Non invasive venous ultrasoundCords that are present in the participant's axilla and/or arm will be imaged with an ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants must be enrolled in Partners protocol # 2008P000540 "Prospective Analysis of Symptoms, Functionality and Quality of Life Questionnaires to Evaluate Lymphedema in Patients Following Treatment for Breast Cancer"
- Confirmed case of cording by a medical provider (Physician, Nurse Practitioner, Physician Assistant)
- Participants must be at least 18 years of age
- Life expectancy of greater than 1 year.
- Ability to understand and the willingness to sign a written informed consent document.
Key exclusion criteria (4 listed)
- Participants who are not enrolled or have been removed from Partners Protocol # 2008P000540 will be excluded from this trial.
- Participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- History of prior surgery or radiation to the head, neck, upper limb, or trunk.
- Patients with a history of a different malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin.
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 |
|---|---|---|
| Non invasive venous ultrasoundSubjects will undergo a venous duplex ultrasound, on a General Electric LOGIQ-9 unit with a Phillips-IU-22 probe | Other | Ultrasound imaging |
Primary outcome
The pathophysiology of cording following treatment for breast cancer
Time frame: 7 days
The cohort of 15 subject's images will be reviewed by the PI and a designated physician from the department of vascular medicine to determine if there is a vascular origin in the cords. Each image will be accessed for the following findings or involvement: Venous, lymphatic, fluid pockets, and striations on the cord.
1 secondary outcome
Cording and the onset of breast cancer related lymphedema
Time frame: 30 days
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 16 Mar 2016.
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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.
Alphonse G Taghian, MD PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non invasive venous ultrasound in people with Breast Cancer, run by Massachusetts General Hospital at 1 site in United States.
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 6 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: finished, as of the sponsor's last update on 16 Mar 2016. 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 United States. 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?
The pathophysiology of cording following treatment for breast cancer (time frame: 7 days). 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 16 Mar 2016.