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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
450
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.
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.
The Penn TREC Survivorship Center
Hershey, Pennsylvania, United States
Percent interlimb difference, change over 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
Time frame: Baseline and 12 months
Clinical Lymphedema Events
Flare-ups and cellulitic infections (number and type recorded)
Time frame: Data collected over the 12 month follow-up, with events collected as reported
Clinical Evaluation Score for Lymphedema
Standardized clinical evaluation survey completed by certified lymphatic therapists
Time frame: Baseline and 12 months
Norman Lymphedema Survey
Thirteen symptoms, recorded within a standardized survey (Norman Lymphedema Survey)
Time frame: Baseline and 12 months
Weight loss
body weight loss over 12 months
Time frame: Baseline and 12 months
Biomarkers: Estradiol
circulating estradiol levels in the blood
Time frame: baseline and 12 months
Biomarkers: Testosterone
circulating testosterone levels in the blood
Time frame: baseline and 12 months
Biomarkers - Sex Hormone Binding Globulin
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circulating sex hormone binding globulin levels in the blood
Time frame: baseline and 12 months
Inflammation: Interleukin six
Circulating interleukin six levels in the blood
Time frame: baseline and 12 months
Inflammation: C reactive protein
Circulating c reactive protein levels in the blood
Time frame: baseline and 12 months
Adiponectin
circulating Adiponectin levels in the blood
Time frame: baseline and 12 months
Leptin
circulating leptin levels in the blood
Time frame: baseline and 12 months
F2-isoprostanes
circulating F2-isoprostane levels in the blood
Time frame: baseline and 12 months
Insulin
circulating insulin levels in the blood
Time frame: baseline and 12 months
Glucose
circulating glucose levels in the blood
Time frame: baseline and 12 months
insulin like growth factor one
circulating levels of insulin like growth factor one in the blood
Time frame: baseline and 12 months
insulin like growth factor binding protein three
circulating levels of insulin like growth factor binding protein three in the blood
Time frame: baseline and 12 months
Upper limb lymphedema twenty seven
27 item survey on lymphedema quality of life
Time frame: baseline and 12 months
body image and relationship survey
32 item survey on body image specifically developed for breast cancer survivors
Time frame: baseline and 12 months