LymphedemaNCT00959985

Early Detection and Intervention for Mild and Moderate Lymphedema in Patients Treated for Breast Cancer

A study testing Compression Sleeve and Short-Stretch Compression Bandage in people with Lymphedema and Breast Cancer, run by Massachusetts General Hospital at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Lymphedema, Breast Cancer
What is being tested?: Compression Sleeve and Short-Stretch Compression Bandage
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 23 participants
Where: 1 siteUnited States
Study dates: Aug 2009to Aug 2014
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 have histologically or cytologically confirmed invasive or in-situ carcinoma of the breast
Participants must have undergone sentinel lymph node mapping or axillary dissection
Participants must have had a pre-operative Perometer measurement, and consecutive measurement at 4-6 month intervals prior to the onset of low volume edema (>5% from baseline)
Age > 18 years
Life expectancy of greater than 1 year
Participants must have a Perometer measurement of 5% or greater volume difference (RVC) to qualify for randomization
Ability to understand and willingness to sign a written informed consent document
Willingness to comply with required follow up Perometer measurements and clinical visits

Who cannot join

Known metastatic disease or other locally advanced disease in the thoracic or cervical regions
Any patient who will not be returning routinely for follow-up
Known brain metastases will 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 primary lymphedema
History of prior surgery or radiation to the head, neck, upper limb, or trunk
Evidence that axillary lymph node malignancy is causing lymphedema due to recurrence as per physician discretion

Show all 9Show fewer

Any patient who has bilateral lymph node mapping or dissection
Any patient with a current case of cellulitis
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 cancer 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

Other trials in United States

About this study

Official title: Early Detection and Intervention for Mild and Moderate Lymphedema in Patients Treated for Breast Cancer: A Randomized Trial

Women who have been treated for breast cancer may be at risk for lymphedema or arm swelling. Currently, there are no clear treatment guidelines for lymphedema. One treatment method used to treat lymphedema is the use of compression sleeves to encourage the flow of lymph fluid out of the arms and prevent arm swelling in the future. Another treatment method is more intensive and involves wearing compression sleeves as well as special compression bandages overnight. It is unclear whether the use of compression with both sleeves and bandaging is more effective in treating lymphedema than the use of compression sleeves alone. The purpose of this research study is to evaluate the effectiveness of the use of compression garments in preventing or slowing the progression of lymphedema in breast cancer patients.

Read the detailed description

Because no one knows which of the study options is best, participant's will be randomized into one of the study groups. Participants with mild lymphedema will be randomized into either Group 1A or Group 1B. Participants with moderate lymphedema will be randomized into either Group 2A or Group 2B.
All study participants will meet with a lymphedema physical therapist to review daily shoulder range of motion exercises to help minimize their arm swelling. They will be asked to record their range of motion exercises and activities in a study treatment journal. Participants will bring their journal to each study visit (every 4 weeks).
Group 1A will only be required to meet with the lymphedema physical therapist as described above.
Group 1B and Group 2A will be fitted with a compression sleeve at their first lymphedema physical therapy visit. They will wear the sleeve for a minimum of 12 hours per day.
Group 2B will also be fitted with a compression sleeve at their first lymphedema physical therapy visit and will wear the sleeve for a minimum of 12 hours per day. They will also be instructed to wear a short-stretch compression bandage that goes from the top of the hand to the armpit. They will be asked to wear this compression bandage during the night. The overnight compression bandage should be worn for at least 5 nights out of the week.
Participants will come to the clinic every 4 weeks. The following tests and procedures will be performed: height and weight measurements; review of any side effects; arm volume measurements for both arms; questionnaire.

Conditions: Lymphedema, Breast Cancer
Being tested: Compression Sleeve, Short-Stretch Compression Bandage
Keywords: compression sleeve, compression bandage
Medical subject headings: Lymphedema, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Compression SleeveDevice
Worn for a minimum of 12 hours per day
Short-Stretch Compression BandageDevice
Worn overnight at least 5 nights of the week

Study groups in NCT00959985
Study group	Role	What they receive
Group 1A	No intervention	Mild Lymphedema: Only required to meet with the lymphedema physical therapist
Group 1B	Active comparator	Mild Lymphedema: Fitted for compression sleeve Receives: Device: Compression Sleeve
Group 2A	Active comparator	Moderate lymphedema: Fitted with a compression sleeve Receives: Device: Compression Sleeve
Group 2B	Active comparator	Moderate Lymphedema: Fitted with compression sleeve and instructed to wear a short-stretch compression bandage Receives: Device: Compression Sleeve; Device: Short-Stretch Compression Bandage

What is being measured

The primary outcome is the main question the study is designed to answer.

To Identify the Number of Patients Who Experienced Reduction in Edema With Compression Garment Usage for Low Volume Lymphedema Associated With Breast Cancer Treatment
Participants who are randomized to receive compression treatment will have their arm volume measured at regular intervals throughout the study period. Participants' arm volume, as measured by the validated Relative Volume Change (RVC) equation, at the end of the intervention period will be assessed to determine the efficacy of the compression garment intervention and whether or not it was successful in reducing the participants' arm edema to RVC<10%.Data was collected in study participants enrolled in Group 1A and Group 1B only (15 patients total), and the percentage of participants who experienced reduction in edema is reported below.
Measured: 5 years
To Identify the Number of Patients Who Experienced Reduction in Edema With Compression Garments +/- Night Compression Bandaging for Moderate Volume Lymphedema Due to Breast Cancer Treatment
Participants who are randomized to receive compression treatment with/without night bandaging will have their arm volume measured at regular intervals throughout the study period. Participants' arm volume, as measured by the validated Relative Volume Change (RVC) equation, at the end of the intervention period will be assessed to determine the efficacy of the compression garment intervention and whether or not it was successful in reducing the participants' arm edema to RVC<10%. Data was collected in participants enrolled in Group 2A and 2B only (8 participants total), and the percentage of participants who experienced reduction in edema is reported below.
Measured: 5 years
To Assess Survey Response Scores Regarding Symptoms Associated With Varying Degrees of Lymphedema
Symptoms were assessed through the Lymphedema Evaluation Following Treatment of Breast Cancer (LEFT-BC) survey. The responses were scored on a scale from 0-51, where higher score was associated with presence of more symptoms (0=no symptoms, 51 = most symptoms)
Measured: 5 years
To Assess Survey Response Scores Regarding Fear Avoidance Behavior Associated With Varying Degrees of Lymphedema
Fear avoidance behavior was assessed through the Lymphedema Evaluation Following Treatment of Breast Cancer (LEFT-BC) survey. Participant responses were scored on a scale from 7-28, where higher score was associated with higher level of fear of using arm (7= least fear level; 28= most fear level)
Measured: 5 years
To Assess Survey Response Scores Regarding Quality of Life as it Associated With Varying Degrees of Lymphedema
Quality of life was assessed through the Lymphedema Evaluation Following Treatment of Breast Cancer (LEFT-BC) survey. Participant responses were scored on a scale from 0-141, where higher score was associated with higher post-operative quality of life (0= worst; 141= best)
Measured: 5 years
To Assess Survey Response Scores Regarding Upper Extremity Function as it Associated With Varying Degrees of Lymphedema
Upper extremity functions were assessed through the Lymphedema Evaluation Following Treatment of Breast Cancer (LEFT-BC) survey. Participant responses were scored on a scale from 19-95, where higher score was associated with more difficulty utilizing arm for daily activities (19 = least difficulty; 95 = most difficulty)
Measured: 5 years

Secondary outcomes (2)

To Identify the Number of Patients With Risk Factors Associated With the Onset of Lymphedema That Are Both Related and Unrelated to Treatment for Breast Cancer
Surgical and radiation therapy risk factors for lymphedema (surgery to lymph nodes, radiation to lymph nodes), as well as risk factors unrelated to breast cancer treatment such as high BMI were collected upon medical record review
Measured: 5 years
To Evaluate the Number of Patients With Low-level Arm Swelling in Order to Understand the Natural History of Lymphedema After Treatment for Breast Cancer
We recorded the number of participants who had low-level arm swelling, as defined by the Relative Volume Change (RVC) equation of >5%-<10%, at the time of their post-operative follow up to determine if women who had low-level arm swelling were more likely to develop lymphedema
Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2009Aug 2014

First posted17 Aug 2009 (estimated)
Study startAug 2009
Primary completionAug 2014
Study completionAug 2014

Why it stopped: low accrual

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for LymphedemaStudies 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 23 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00959985
Sponsor's protocol ID: 08-308
Other IDs: R01CA139118
Status last verified: Apr 2017
First submitted: 14 Aug 2009
Last updated: 30 May 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
Enrolling by invitation
Comparison of the Effects of Kinesio Taping and Compression Bandaging on Edema, Range of Motion, Upper Extremity Function, and Grip Strength in Patients With Breast Cancer-Related Lymphedema
Lymphedema, Lymphedema Arm
RecruitingObservational study
A Post-market, Real-world Experience: Expanding Access to Care by Incorporating the Symani® Surgical System and Enabling Surgeons
Open Surgery, Lymphedema
Not yet recruiting
Agentic AI App and Home Bioimpedance Monitoring for Endocrine Therapy Adherence and Lymphedema in Breast Cancer Survivors
Breast Neoplasm Malignant Primary, Lymphedema Arm
Active, not recruiting
The Effectiveness of Lymphatic Bypass Supermicrosurgery
Breast Cancer Related Lymphedema, Lymphedema Arm

All Lymphedema trials

Study at a glance

From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Early Detection and Intervention for Mild and Moderate Lymphedema in Patients Treated for Breast Cancer: A Randomized Trial
ClinicalTrials.gov ID: NCT00959985
Acronym / sponsor ID: 08-308
Conditions: Lymphedema, Breast Cancer
Keywords: compression sleeve, compression bandage
Study type: Interventional
Recruitment status: TerminatedReason stopped: low accrual
Enrolment: 23 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: Aug 2009
Primary completion: Aug 2014 (actual)
Study completion: Aug 2014 (actual)
First posted: 17 Aug 2009 (estimated)
Results: Posted 27 Apr 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Because no one knows which of the study options is best, participant's will be randomized into one of the study groups. Participants with mild lymphedema will be randomized into either Group 1A or Group 1B. Participants with moderate lymphedema will be randomized into either Group 2A or Group 2B.
All study participants will meet with a lymphedema physical therapist to review daily shoulder range of motion exercises to help minimize their arm swelling. They will be asked to record their range of motion exercises and activities in a study treatment journal. Participants will bring their journal to each study visit (every 4 weeks).
Group 1A will only be required to meet with the lymphedema physical therapist as described above.
Group 1B and Group 2A will be fitted with a compression sleeve at their first lymphedema physical therapy visit. They will wear the sleeve for a minimum of 12 hours per day.
Group 2B will also be fitted with a compression sleeve at their first lymphedema physical therapy visit and will wear the sleeve for a minimum of 12 hours per day. They will also be instructed to wear a short-stretch compression bandage that goes from the top of the hand to the armpit. They will be asked to wear this compression bandage during the night. The overnight compression bandage should be worn for at least 5 nights out of the week.
Participants will come to the clinic every 4 weeks. The following tests and procedures will be performed: height and weight measurements; review of any side effects; arm volume measurements for both arms; questionnaire.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Group 1A	No intervention	–Mild Lymphedema: Only required to meet with the lymphedema physical therapist
Group 1B	Active comparator	Device: Compression SleeveMild Lymphedema: Fitted for compression sleeve
Group 2A	Active comparator	Device: Compression SleeveModerate lymphedema: Fitted with a compression sleeve
Group 2B	Active comparator	Device: Compression Sleeve, Device: Short-Stretch Compression BandageModerate Lymphedema: Fitted with compression sleeve and instructed to wear a short-stretch compression bandage

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Participants must have histologically or cytologically confirmed invasive or in-situ carcinoma of the breast
Participants must have undergone sentinel lymph node mapping or axillary dissection
Participants must have had a pre-operative Perometer measurement, and consecutive measurement at 4-6 month intervals prior to the onset of low volume edema (>5% from baseline)
Age > 18 years
Life expectancy of greater than 1 year

Key exclusion criteria (9 listed)

Known metastatic disease or other locally advanced disease in the thoracic or cervical regions
Any patient who will not be returning routinely for follow-up
Known brain metastases will 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 primary lymphedema
History of prior surgery or radiation to the head, neck, upper limb, or trunk

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
Compression SleeveWorn for a minimum of 12 hours per day	Device	Group 1B, Group 2A, Group 2B
Short-Stretch Compression BandageWorn overnight at least 5 nights of the week	Device	Group 2B

Primary outcome

To Identify the Number of Patients Who Experienced Reduction in Edema With Compression Garment Usage for Low Volume Lymphedema Associated With Breast Cancer Treatment
Time frame: 5 years
Participants who are randomized to receive compression treatment will have their arm volume measured at regular intervals throughout the study period. Participants' arm volume, as measured by the validated Relative Volume Change (RVC) equation, at the end of the intervention period will be assessed to determine the efficacy of the compression garment intervention and whether or not it was successful in reducing the participants' arm edema to RVC<10%.Data was collected in study participants enrolled in Group 1A and Group 1B only (15 patients total), and the percentage of participants who experienced reduction in edema is reported below.
To Identify the Number of Patients Who Experienced Reduction in Edema With Compression Garments +/- Night Compression Bandaging for Moderate Volume Lymphedema Due to Breast Cancer Treatment
Time frame: 5 years
Participants who are randomized to receive compression treatment with/without night bandaging will have their arm volume measured at regular intervals throughout the study period. Participants' arm volume, as measured by the validated Relative Volume Change (RVC) equation, at the end of the intervention period will be assessed to determine the efficacy of the compression garment intervention and whether or not it was successful in reducing the participants' arm edema to RVC<10%. Data was collected in participants enrolled in Group 2A and 2B only (8 participants total), and the percentage of participants who experienced reduction in edema is reported below.
To Assess Survey Response Scores Regarding Symptoms Associated With Varying Degrees of Lymphedema
Time frame: 5 years
Symptoms were assessed through the Lymphedema Evaluation Following Treatment of Breast Cancer (LEFT-BC) survey. The responses were scored on a scale from 0-51, where higher score was associated with presence of more symptoms (0=no symptoms, 51 = most symptoms)
To Assess Survey Response Scores Regarding Fear Avoidance Behavior Associated With Varying Degrees of Lymphedema
Time frame: 5 years
Fear avoidance behavior was assessed through the Lymphedema Evaluation Following Treatment of Breast Cancer (LEFT-BC) survey. Participant responses were scored on a scale from 7-28, where higher score was associated with higher level of fear of using arm (7= least fear level; 28= most fear level)
To Assess Survey Response Scores Regarding Quality of Life as it Associated With Varying Degrees of Lymphedema
Time frame: 5 years
Quality of life was assessed through the Lymphedema Evaluation Following Treatment of Breast Cancer (LEFT-BC) survey. Participant responses were scored on a scale from 0-141, where higher score was associated with higher post-operative quality of life (0= worst; 141= best)
To Assess Survey Response Scores Regarding Upper Extremity Function as it Associated With Varying Degrees of Lymphedema
Time frame: 5 years
Upper extremity functions were assessed through the Lymphedema Evaluation Following Treatment of Breast Cancer (LEFT-BC) survey. Participant responses were scored on a scale from 19-95, where higher score was associated with more difficulty utilizing arm for daily activities (19 = least difficulty; 95 = most difficulty)

2 secondary outcomes

To Identify the Number of Patients With Risk Factors Associated With the Onset of Lymphedema That Are Both Related and Unrelated to Treatment for Breast Cancer
Time frame: 5 years
To Evaluate the Number of Patients With Low-level Arm Swelling in Order to Understand the Natural History of Lymphedema After Treatment for Breast Cancer
Time frame: 5 years

Results and safety

Results posted to the registry on 27 Apr 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1A	8	8
Group 1B	7	7
Group 2A	4	4
Group 2B	4	4

Primary outcome: To Identify the Number of Patients Who Experienced Reduction in Edema With Compression Garment Usage for Low Volume Lymphedema Associated With Breast Cancer Treatment

Time frame: 5 years. Count of participants. Unit: Participants

Measure	Group 1A n = 8	Group 1B n = 7	Group 2A n = 0	Group 2B n = 0
Value	7	4	–	–

Population analysed: This outcome measure was compared between Group 1A (control) and Group 1B (compression garment). No data was collected for this outcome in Groups 2A and 2B

Primary outcome: To Identify the Number of Patients Who Experienced Reduction in Edema With Compression Garments +/- Night Compression Bandaging for Moderate Volume Lymphedema Due to Breast Cancer Treatment

Time frame: 5 years. Count of participants. Unit: Participants

Measure	Group 1A n = 0	Group 1B n = 0	Group 2A n = 4	Group 2B n = 4
Value	0	0	2	3

Population analysed: This outcome measure was compared between Groups 2A and 2B. No data was collected for Group 1A and 1B as this outcome does not apply to these groups

Primary outcome: To Assess Survey Response Scores Regarding Symptoms Associated With Varying Degrees of Lymphedema

Time frame: 5 years. Median (Full Range). Unit: units on a scale

Measure	Group 1A n = 5	Group 1B n = 7	Group 2A n = 2	Group 2B n = 1
Value	4 (3.25 to 10)	6.46 (1 to 20)	6.58 (5.5 to 7.67)	2.4 (2.4 to 2.4)

Population analysed: Median scores of the symptom-related questions on the LEFT-BC survey, per group, are indicated below. Participants who did not complete or return surveys due to non-compliance were excluded from this analysis.

Primary outcome: To Assess Survey Response Scores Regarding Fear Avoidance Behavior Associated With Varying Degrees of Lymphedema

Time frame: 5 years. Median (Full Range). Unit: units on a scale

Measure	Group 1A n = 5	Group 1B n = 7	Group 2A n = 2	Group 2B n = 1
Value	13.3 (10 to 20.25)	16.5 (12.67 to 19.4)	20.75 (19.67 to 21.8)	17 (17 to 17)

Population analysed: Median scores for the fear avoidance behavior section on the LEFT-BC survey, per group, are indicated below. Participants who did not complete or return surveys due to non-compliance were excluded from this analysis.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 5 years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1A	0 of 8 (0%)	1 of 8 (12.5%)	0 of 8
Group 1B	0 of 7 (0%)	3 of 7 (42.9%)	0 of 7
Group 2A	0 of 4 (0%)	2 of 4 (50%)	0 of 4
Group 2B	0 of 4 (0%)	2 of 4 (50%)	0 of 4

Limitations and caveats (from the sponsor): This trial was terminated due to slow accrual and small number of subjects for whom data was collected (23 out of expected 334). Study did not reach statistical power to conduct detailed analysis, results should be interpreted with this in mind

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

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Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
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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 Compression Sleeve and Short-Stretch Compression Bandage in people with Lymphedema and 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 8 inclusion and 9 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: stopped early, as of the sponsor's last update on 30 May 2017. 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?

Yes. Results are posted in the registry (first posted 27 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Identify the Number of Patients Who Experienced Reduction in Edema With Compression Garment Usage for Low Volume Lymphedema Associated With Breast Cancer Treatment (time frame: 5 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00959985.

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 30 May 2017.