The Women In Steady Exercise Research (WISER) Survivor Trial
- Conditions
- Lymphedema
- Interventions
- Behavioral: Exercise InterventionBehavioral: Weight Loss Intervention
- Registration Number
- NCT01515124
- Lead Sponsor
- Milton S. Hershey Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 450
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Exercise only Exercise Intervention 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. Exercise and Weight loss combined 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. Weight loss only Weight 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. 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. Exercise and Weight loss combined Exercise 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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)
Weight loss Baseline and 12 months body weight loss over 12 months
Biomarkers - Sex Hormone Binding Globulin baseline and 12 months circulating sex hormone binding globulin levels in the blood
F2-isoprostanes baseline and 12 months circulating F2-isoprostane levels in the blood
insulin like growth factor one baseline and 12 months circulating levels of insulin like growth factor one in the blood
Clinical Evaluation Score for Lymphedema Baseline and 12 months Standardized clinical evaluation survey completed by certified lymphatic therapists
Leptin baseline and 12 months circulating leptin levels in the blood
Biomarkers: Testosterone baseline and 12 months circulating testosterone levels in the blood
Insulin baseline and 12 months circulating insulin levels in the blood
body image and relationship survey baseline and 12 months 32 item survey on body image specifically developed for breast cancer survivors
Norman Lymphedema Survey Baseline and 12 months Thirteen symptoms, recorded within a standardized survey (Norman Lymphedema Survey)
Biomarkers: Estradiol baseline and 12 months circulating estradiol levels in the blood
Adiponectin baseline and 12 months circulating Adiponectin levels in the blood
Glucose baseline and 12 months circulating glucose levels 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
Upper limb lymphedema twenty seven baseline and 12 months 27 item survey on lymphedema quality of life
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
Trial Locations
- Locations (1)
The Penn TREC Survivorship Center
🇺🇸Hershey, Pennsylvania, United States