Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is being done because women have arm swelling for more than 6 months despite wrapping and other treatments. This swelling is called lymphedema. It is the back up of lymph system fluid that causes swelling in the arm. The swelling can just happen, but more commonly it is caused when lymph nodes are removed during cancer surgery. It can develop right after breast cancer treatment or weeks, months or even years later. In our preliminary research, the investigators found that more than 1/3 of the 33 patients showed at least a 30% reduction in lymphedema following acupuncture treatment and there were no serious adverse events during the treatment or 6 month followup.
This study will include a larger group of patients. Patients will be assigned to one of two groups, and results of the groups will be compared to see if acupuncture can reduce lymphedema and whether the effect lasts after acupuncture treatment is completed.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupuncture | Experimental | Patients in the acupuncture group will receive acupuncture treatment twice weekly for six consecutive weeks. |
|
| Wait-list | Experimental | Patients in the wait-list control group will cross over and receive acupuncture twice weekly for 6 consecutive weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture | Procedure | Each treatment will be 30 minutes in duration. Patients will receive two acupuncture treatments each week for six consecutive weeks. Patients will be advised to continue their standard lymphedema treatments such as exercise or use of compression garments if these were in use prior to clinical trial participation. |
| Measure | Description | Time Frame |
|---|---|---|
| Lymphedema as Measured at Baseline and at 6 Weeks | Changes in lymphedema between groups, as measured by mean arm circumference assessed at baseline and after 6 weeks from baseline. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Measurements for Bioimpedance for Treatment Arms at Baseline and 6 Weeks | Bioimpedance measured using Impedimed L-Dex U400, which measures the rate of electrical current transmission through tissues and estimate fluid content in a lymphedematous limb compared with the normal limb. | 6 weeks |
| Number of Participants Evaluated for Adverse Events |
Not provided
Inclusion Criteria:
The larger of the two measures-upper arm or forearm- will be used for analysis.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ting Bao, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
Not provided
| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Acupuncture | Patients in the acupuncture group will receive acupuncture treatment twice weekly for six consecutive weeks. Acupuncture: Each treatment will be 30 minutes in duration. Patients will receive two acupuncture treatments each week for six consecutive weeks. Patients will be advised to continue their standard lymphedema treatments such as exercise or use of compression garments if these were in use prior to clinical trial participation. |
| FG001 | Wait-list | Patients in the wait-list control group will cross over and receive acupuncture twice weekly for 6 consecutive weeks. Wait-list: For participants in the wait-list control group, follow-up objective and subjective assessments of lymphedema will be performed after approximately 6 weeks on the wait-list, before onset of acupuncture treatment, following 6 weeks of acupuncture treatment and about 3 months after completion of treatment. BMI will be measured at the same timepoints. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Acupuncture | Patients in the acupuncture group will receive acupuncture treatment twice weekly for six consecutive weeks. Acupuncture: Each treatment will be 30 minutes in duration. Patients will receive two acupuncture treatments each week for six consecutive weeks. Patients will be advised to continue their standard lymphedema treatments such as exercise or use of compression garments if these were in use prior to clinical trial participation. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Lymphedema as Measured at Baseline and at 6 Weeks | Changes in lymphedema between groups, as measured by mean arm circumference assessed at baseline and after 6 weeks from baseline. | Posted | Mean | Standard Deviation | cm | 6 weeks |
|
1 year
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Acupuncture | Patients in the acupuncture group will receive acupuncture treatment twice weekly for six consecutive weeks. Acupuncture: Each treatment will be 30 minutes in duration. Patients will receive two acupuncture treatments each week for six consecutive weeks. Patients will be advised to continue their standard lymphedema treatments such as exercise or use of compression garments if these were in use prior to clinical trial participation. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ting Bao MD | Memorial Sloan Kettering Cancer Center | 646-888-0865 | baot@mskcc.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 29, 2016 | May 18, 2018 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| D014850 | Waiting Lists |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D001071 | Appointments and Schedules |
| D009934 | Organization and Administration |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Wait-list | Procedure | For participants in the wait-list control group, follow-up objective and subjective assessments of lymphedema will be performed after approximately 6 weeks on the wait-list, before onset of acupuncture treatment, following 6 weeks of acupuncture treatment and about 3 months after completion of treatment. BMI will be measured at the same timepoints. |
|
| 1. 5 years |
| BG001 | Wait-list | Patients in the wait-list control group will cross over and receive acupuncture twice weekly for 6 consecutive weeks. Wait-list: For participants in the wait-list control group, follow-up objective and subjective assessments of lymphedema will be performed after approximately 6 weeks on the wait-list, before onset of acupuncture treatment, following 6 weeks of acupuncture treatment and about 3 months after completion of treatment. BMI will be measured at the same timepoints. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
Patients in the wait-list control group will cross over and receive acupuncture twice weekly for 6 consecutive weeks.
Wait-list: For participants in the wait-list control group, follow-up objective and subjective assessments of lymphedema will be performed after approximately 6 weeks on the wait-list, before onset of acupuncture treatment, following 6 weeks of acupuncture treatment and about 3 months after completion of treatment. BMI will be measured at the same timepoints.
|
|
| Secondary | Measurements for Bioimpedance for Treatment Arms at Baseline and 6 Weeks | Bioimpedance measured using Impedimed L-Dex U400, which measures the rate of electrical current transmission through tissues and estimate fluid content in a lymphedematous limb compared with the normal limb. | Posted | Mean | Standard Deviation | ohms | 6 weeks |
|
|
|
| Secondary | Number of Participants Evaluated for Adverse Events | Posted | Count of Participants | Participants | 1. 5 years |
|
|
|
| 6 |
| 40 |
| 12 |
| 40 |
| 20 |
| 40 |
| EG001 | Wait-list | Patients in the wait-list control group will cross over and receive acupuncture twice weekly for 6 consecutive weeks. Wait-list: For participants in the wait-list control group, follow-up objective and subjective assessments of lymphedema will be performed after approximately 6 weeks on the wait-list, before onset of acupuncture treatment, following 6 weeks of acupuncture treatment and about 3 months after completion of treatment. BMI will be measured at the same timepoints. | 7 | 42 | 7 | 42 | 11 | 42 |
| Gastric Hemorrhage | Gastrointestinal disorders | Systematic Assessment |
|
| Gen disorders & admin site conditions Other, spec | General disorders | Systematic Assessment |
|
| Hematuria | Renal and urinary disorders | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypophosphatemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | Systematic Assessment |
|
| Platelet count decreased | Investigations | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Skin & subcutaneous tissue disorders Other, spec | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Platelet count decreased | Investigations | Systematic Assessment |
|
| White blood cell decreased | Investigations | Systematic Assessment |
|
| Dry Skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D006298 | Health Services Administration |