An interventional study of Exercise Intervention and Weight Loss Intervention in Lymphedema, sponsored by Milton S. Hershey Medical Center. Completed at 1 site in United States. Open to female participants aged Up to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-10-10.
Sponsored by Milton S. Hershey Medical Center · Not applicable, Interventional, and Supportive care
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.
560 studies on the registry are indexed under Lymphedema; 135 are open to participants now.
This study's enrollment of 450 is above the median of 50 across 403 interventional studies indexed under Lymphedema.
Browse Lymphedema studies →Milton S. Hershey Medical Center is the lead sponsor of 480 studies on the registry; 61 are open to participants now.
Of its 56 completed or terminated interventional studies of FDA-regulated products, 42 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
All 4 groups receive lymphedema care as follows: 1. 2 custom fitted compression garments (baseline and 6 months) 2. evaluations for flare-ups at request (and at each measurement time point) 3. lymphedema treatment by a certified lymphatic therapist upon detection of a flare-up, paid for by the study. No limit was placed on number of sessions.
The Exercise Intervention combines 60-90 minute twice-weekly supervised weight-lifting sessions with 180 minutes of weekly aerobic exercise. Women will be trained by certified fitness professionals in both the 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. All exercise participants will be provided with 'Power Blocks' which are adjustable dumbbells with which they can increase resistance in 1-2 pound increments from 1-21 pounds. All weight training will be done in their homes except for the first 6 weekly session and monthly check-in sessions. Exercise only group members also received the Lymphedema care intervention described above.
Behavioral: Exercise 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. Participants will be guided to stay at the same number of calories per day until reaching goal weight, followed by a gradual increase in caloric intake (of approximately 500 calories/d) to maintain their weight throughout the remainder of the intervention. The treatment groups will be led by registered dietitians and will receive ongoing supervision via telephone and email contact. Weight loss only group members also received the Lymphedema care intervention described above.
Behavioral: Weight Loss Intervention
Participants in this group will receive a combination of the supervised twice-weekly weight training sessions and the weight loss program. Combined group members also received the Lymphedema care intervention described above.
Behavioral: Exercise Intervention · Behavioral: Weight Loss 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.
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.
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
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
breast cancer recurrence
participants will be followed for breast cancer recurrence
Time frame: 10 years post trial
mortality
participants will be followed for mortality
Time frame: 10 years post trial
Plan to share: No
This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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Milton S. Hershey Medical Center