Lymphedema
Conditions
Keywords
Lymphedema, Strength training intervention, Weight loss intervention, Breast cancer recurrence, Cost Effectiveness
Brief summary
WISER Survivor is a one year weight loss and exercise study for sedentary breast cancer survivors who are overweight or obese with breast cancer related lymphedema. There will be four groups in this trial: exercise only, weight loss only, exercise and weight-loss combined, and a control group. The primary purpose of this study is to test the effects of these interventions on clinical lymphedema outcomes. Secondary outcomes include weight loss, breast cancer related biomarkers, and quality of life. To the extent that funding will be available, participants will be followed long term to examine effects on recurrence and mortality.
Interventions
BEHAVIORALExercise Intervention
The Exercise Intervention combines the twice-weekly weight-lifting intervention from PAL with the 180 minutes of weekly aerobic exercise from the recently completed WISER trial and the ongoing WISER Sister Trial. Women will be trained by certified fitness professionals in both the PAL weight-lifting intervention and in safely increasing their aerobic exercise activity over 6 weekly sessions, and then monitored through phone contact, and monthly in-person sessions.
BEHAVIORALWeight Loss Intervention
The Weight Loss Intervention begins with a 24 week intensive phase that includes weekly meetings and provision of all meals and snacks from a commercial manufacturer (NutriSystem, Inc., Fort Washington, PA). Daily caloric intake will be strictly controlled during this first 24 weeks at 1200-1500 calories per day.
Sponsors
Milton S. Hershey Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
All participants asked at the start of each measurement encounter not to inform measurement staff of their randomization group status. All measurement staff asked to guess group status at end of each measurement encounter. Patterns of responses beyond chance result in corrective action to improve masking (e.g.; requests from PI for participants to mask group status)
Eligibility
Sex/Gender
FEMALE
Age
No minimum to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* breast cancer survivor * overweight or obese (BMI of 25 or greater) * must have breast cancer related lymphedema * at least 6 months post-treatment (e.g. surgery, chemotherapy, or radiotherapy) but there will be no upper limit on time elapsed from diagnosis * the eligible age range will have no lower limit. * currently free of cancer
Exclusion criteria
* medical conditions or medications that would prohibit participation in an exercise program or would negatively impact our ability to test our primary aims * inability to walk for 6 minutes unaided * extremely obese (body mass index greater or equal to 50 kg/m2) * plans for additional (e.g. curative or reconstructive) surgery during the study period * self-report of weight-lifting within the past year * already engaging in 3 or more times weekly aerobic activity of moderate intensity * planning to move away from the area over the next year * current use of weight loss medication (OTC or prescription) * self-report of alcohol or substance abuse within the past 12 months, including at-risk drinking (current consumption of more than 14 alcoholic drinks per week) * weight loss of greater than 10 % in the past 3 months * history of bariatric surgery * women who are pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent interlimb difference, change over 12 months. | Baseline and 12 months | Arm volumes for affected and unaffected limbs will be measured by perometry and the % difference will be determined at baseline and 12 months. the absolute percentage point difference of differences (% interlimb difference at 12 months minus % interlimb difference at baseline) will be the primary outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Lymphedema Events | Data collected over the 12 month follow-up, with events collected as reported | Flare-ups and cellulitic infections (number and type recorded) |
| Clinical Evaluation Score for Lymphedema | Baseline and 12 months | Standardized clinical evaluation survey completed by certified lymphatic therapists |
| Norman Lymphedema Survey | Baseline and 12 months | Thirteen symptoms, recorded within a standardized survey (Norman Lymphedema Survey) |
| Weight loss | Baseline and 12 months | body weight loss over 12 months |
| Biomarkers: Estradiol | baseline and 12 months | circulating estradiol levels in the blood |
| Biomarkers: Testosterone | baseline and 12 months | circulating testosterone levels in the blood |
| Biomarkers - Sex Hormone Binding Globulin | baseline and 12 months | circulating sex hormone binding globulin levels in the blood |
| Inflammation: Interleukin six | baseline and 12 months | Circulating interleukin six levels in the blood |
| Inflammation: C reactive protein | baseline and 12 months | Circulating c reactive protein levels in the blood |
| Upper limb lymphedema twenty seven | baseline and 12 months | 27 item survey on lymphedema quality of life |
| body image and relationship survey | baseline and 12 months | 32 item survey on body image specifically developed for breast cancer survivors |
| Adiponectin | baseline and 12 months | circulating Adiponectin levels in the blood |
| Leptin | baseline and 12 months | circulating leptin levels in the blood |
| F2-isoprostanes | baseline and 12 months | circulating F2-isoprostane levels in the blood |
| Insulin | baseline and 12 months | circulating insulin levels in the blood |
| Glucose | baseline and 12 months | circulating glucose levels in the blood |
| insulin like growth factor one | baseline and 12 months | circulating levels of insulin like growth factor one in the blood |
| insulin like growth factor binding protein three | baseline and 12 months | circulating levels of insulin like growth factor binding protein three in the blood |
Other
| Measure | Time frame | Description |
|---|---|---|
| breast cancer recurrence | 10 years post trial | participants will be followed for breast cancer recurrence |
| mortality | 10 years post trial | participants will be followed for mortality |
Countries
United States
Outcome results
None listed