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| ID | Type | Description | Link |
|---|---|---|---|
| 95970 | Other Identifier | Stanford University Alternate IRB Approval Number | |
| BRSNSTU0007 | Other Identifier | OnCore Number |
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To compare the effectiveness of usual treatments for lymphedema [massage and elastic compression sleeve, instituted at-risk and before the development of swelling (lymphedema)], compared to the use of a newly-marketed device, the Flexitouch, which electronically simulates the effect of massage upon lymph flow.
The current investigation is designed to prospectively evaluate the potential for simple, effective lymphedema prophylaxis in breast cancer survivors who show early evidence of high-risk status. There is growing evidence that the mechanisms of lymphatic repair after injury are mediated through lymphatic flow. Accordingly, this study assess if physical measures designed to prophylactically augment lymphatic flow after surgical interventions for breast cancer (eg, Flexitouch and manual lymphatic massage) will reduce the incidence of lymphatic stagnation, assessed as incidence of lymphedema, when compared to patients who receive conventional "watch and wait" interventions (observation).
The specific aims of the study are
Recent advances in the medical understanding of the biological processes of lymphatic development and repair suggest that these mechanisms may be able to be manipulated to enhance the regenerative responses in the lymphatic vasculature following injury. Breast cancer-associated lymphedema is a model of such an acquired form of lymphatic vasculature insufficiency. Clinically, this poses a substantial clinical problem. It is estimated at 1woman in 4 who survives a breast cancer intervention will develop lymphedema, often progressively. The appearance of lymphedema has documented adverse effects on physical and psychologically well-being. New insights into lymphatic repair suggest that such mechanisms can be employed in a prophylactic fashion to forestall or eliminate the development of lymphedema. This proposal investigates this hypothesis in a prospective fashion, using a randomized trial design in 80 patients enrolled at the time of breast cancer surgery. If the investigation documents a beneficial effect of preventive measures, it could have a profound impact on subsequent breast cancer care. These measures are simple and cost-effective and, could help to eliminate the impact of a substantial detractor to the improved longevity and health that breast cancer survivors otherwise may expect to enjoy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Flexitouch device | Experimental | Participants will self-administer lymphedema management via daily use of the Flexitouch device, an intermittent pneumatic compression device (aka, lymphedema pump) |
|
| Manual Lymphatic Drainage (MLD) | Experimental | Participants will self-administer lymphedema management via daily manual lymphatic massage therapy, using a Class 1 compression garment |
|
| Observational Control (no intervention) | No Intervention | Control group, no intervention. No Flexitouch or manual massage therapy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flexitouch | Device | A standard of care intermittent pneumatic compression device (aka, lymphedema pump) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Successful Assessment of Lymphedema by Multiple Frequency Bioimpedance Spectroscopy | Successful, serial multiple frequency bioimpedance assessment for newly developing lymphedema in the 3 study groups | 36 months |
| Incidence of Lymphedema (Newly-developing) | Incidence of newly-developing lymphedema for each study cohort, as detected by serial multiple frequency bioimpedance spectroscopy scans for increased interstitial fluid within regional tissues. | 3 years of semi-annual follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stanley G Rockson | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
undecided at this time.
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Enrollment commenced in May 2005 and concluded 13 March 2012. Subjects were recruited from the medical clinics and Stanford University Hospital and Clinics.
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| ID | Title | Description |
|---|---|---|
| FG000 | Flexitouch Device | Lymphedema management via Flexitouch device, an intermittent pneumatic compression device (aka, lymphedema pump) |
| FG001 | Manual Lymphatic Drainage (MLD) | Lymphedema management via self-administered manual lymphatic massage therapy |
| FG002 | No Intervention Control | No intervention observational control |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group I | This group of patients will receive the device. |
| BG001 | Group II | This group of patients will receive prophylactic MLD |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Successful Assessment of Lymphedema by Multiple Frequency Bioimpedance Spectroscopy | Successful, serial multiple frequency bioimpedance assessment for newly developing lymphedema in the 3 study groups | All enrolled patients in the trial who did not withdraw or were lost to follow-up | Posted | Number | participants | 36 months |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Flexitouch Device | Participants will self-administer lymphedema management via daily use of the Flexitouch device, an intermittent pneumatic compression device (aka, lymphedema pump) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphedema | Vascular disorders | CTCAE v4 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stanley G. Rockson | Stanford University | 650-725-7571 | rockson@stanford.edu |
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| ID | Term |
|---|---|
| D008209 | Lymphedema |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000073297 | Manual Lymphatic Drainage |
| ID | Term |
|---|---|
| D008405 | Massage |
| D064746 | Therapy, Soft Tissue |
| D026201 | Musculoskeletal Manipulations |
| D000529 | Complementary Therapies |
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| Class 1 compression garment | Device | Manual lymphatic drainage therapy to provide lymphatic massage, using a Class 1 compression garment supporting the arm during heavy exercise or where the risk of trauma maybe increased (ie, flight, elevation, etc). |
|
|
| BG002 | Group III | This is the control group; they will receive no treatment |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG002 | No Intervention Control | No intervention observational control |
|
|
| Primary | Incidence of Lymphedema (Newly-developing) | Incidence of newly-developing lymphedema for each study cohort, as detected by serial multiple frequency bioimpedance spectroscopy scans for increased interstitial fluid within regional tissues. | Posted | Number | participants | 3 years of semi-annual follow-up |
|
|
|
| 0 |
| 19 |
| 1 |
| 19 |
| EG001 | Manual Lymphatic Drainage (MLD) | Participants will self-administer lymphedema management via daily manual lymphatic massage therapy, using a Class 1 compression garment. | 0 | 21 | 5 | 21 |
| EG002 | Observational Control (no Intervention) | Control group, no intervention. No Flexitouch or manual massage therapy | 0 | 22 | 5 | 22 |
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| D001941 |
| Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D013812 |
| Therapeutics |
| D004322 | Drainage |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |