Breast Cancer With Chronic Lymphedema
Conditions
Keywords
acupuncture
Brief summary
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.
Interventions
PROCEDUREAcupuncture
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.
PROCEDUREWait-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.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women age 18 or older * Lymphedema in an arm as a result of surgery, chemotherapy, and/or radiation therapy for breast cancer per breast surgeon or medical oncologist * Patients must have received a clinical diagnosis of lymphedema for at least 6 months and no more than 5 years. This timeframe allows ample time for any surgically related non lymphedema swelling to subside by 6 months post-surgery, while a cap of 5 years will capture the broadest range of cases, and has been used as a timeframe in several studies including our pilot study. * The affected arm must be \>2cm larger than the unaffected arm. Differences of 2 cm or more between the affected and unaffected arm are considered by experts to be clinically significant. Each affected arm will be measured in two areas: upper arm and forearm. The larger of the two measures-upper arm or forearm- will be used for analysis. * Classified as International Society of Lymphology (ISL) stage II or higher as determined by an MSKCC Certified Lymphedema Therapist (CLT).
Exclusion criteria
* Bilateral lymphedema * Previous acupuncture treatment for lymphedema * Concurrent diuretic use * History of primary (congenital) lymphedema * Pregnant or planning to become pregnant during the course of the study * Has an implanted electronically charged medical device
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lymphedema as Measured at Baseline and at 6 Weeks | 6 weeks | Changes in lymphedema between groups, as measured by mean arm circumference assessed at baseline and after 6 weeks from baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measurements for Bioimpedance for Treatment Arms at Baseline and 6 Weeks | 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. |
| Number of Participants Evaluated for Adverse Events | 1. 5 years | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 40 |
| 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. | 42 |
| Total | 82 |
Baseline characteristics
| Characteristic | Acupuncture | Total | Wait-list |
|---|---|---|---|
| Age, Continuous | 65 years | 61 years | 58 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 10 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) White | 31 Participants | 63 Participants | 32 Participants |
| Region of Enrollment United States | 40 Participants | 82 Participants | 42 Participants |
| Sex: Female, Male Female | 40 Participants | 82 Participants | 42 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 6 / 40 | 7 / 42 |
| other Total, other adverse events | 20 / 40 | 11 / 42 |
| serious Total, serious adverse events | 12 / 40 | 7 / 42 |
Outcome results
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.
Time frame: 6 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Acupuncture | Lymphedema as Measured at Baseline and at 6 Weeks | Baseline | 4.74 cm | Standard Deviation 2.23 |
| Acupuncture | Lymphedema as Measured at Baseline and at 6 Weeks | 6 weeks | 4.29 cm | Standard Deviation 2.67 |
| Wait-list | Lymphedema as Measured at Baseline and at 6 Weeks | Baseline | 4.82 cm | Standard Deviation 2.32 |
| Wait-list | Lymphedema as Measured at Baseline and at 6 Weeks | 6 weeks | 4.76 cm | Standard Deviation 2.68 |
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.
Time frame: 6 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Acupuncture | Measurements for Bioimpedance for Treatment Arms at Baseline and 6 Weeks | Baseline | 38.6 ohms | Standard Deviation 30.4 |
| Acupuncture | Measurements for Bioimpedance for Treatment Arms at Baseline and 6 Weeks | 6 Week | 35.9 ohms | Standard Deviation 27.4 |
| Wait-list | Measurements for Bioimpedance for Treatment Arms at Baseline and 6 Weeks | Baseline | 42.2 ohms | Standard Deviation 32.3 |
| Wait-list | Measurements for Bioimpedance for Treatment Arms at Baseline and 6 Weeks | 6 Week | 40.3 ohms | Standard Deviation 35.6 |
Secondary
Number of Participants Evaluated for Adverse Events
Time frame: 1. 5 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Acupuncture | Number of Participants Evaluated for Adverse Events | 40 Participants |
| Wait-list | Number of Participants Evaluated for Adverse Events | 42 Participants |