Clinical trial NCT01515124: The Women In Steady Exercise Research (WISER) Survivor Trial
Official title: The Women In Steady Exercise Research (WISER) Survivor Trial & Cost of Illness and Cost Effectiveness of Alternative Management Strategies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymphedema
Keywords: Lymphedema
Strength training intervention
Weight loss intervention
Breast cancer recurrence
Cost Effectiveness
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2012-01-23
Enrollment: 450
Sex: FEMALE
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percent interlimb difference, change over 12 months.
timeFrame: Baseline and 12 months
Secondary outcomes:
measure: Clinical Lymphedema Events
timeFrame: Data collected over the 12 month follow-up, with events collected as reported
measure: Clinical Evaluation Score for Lymphedema
timeFrame: Baseline and 12 months
measure: Norman Lymphedema Survey
timeFrame: Baseline and 12 months
measure: Weight loss
timeFrame: Baseline and 12 months
measure: Biomarkers: Estradiol
timeFrame: baseline and 12 months
measure: Biomarkers: Testosterone
timeFrame: baseline and 12 months
measure: Biomarkers - Sex Hormone Binding Globulin
timeFrame: baseline and 12 months
measure: Inflammation: Interleukin six
timeFrame: baseline and 12 months
measure: Inflammation: C reactive protein
timeFrame: baseline and 12 months
measure: Adiponectin
timeFrame: baseline and 12 months
measure: Leptin
timeFrame: baseline and 12 months
measure: F2-isoprostanes
timeFrame: baseline and 12 months
measure: Insulin
timeFrame: baseline and 12 months
measure: Glucose
timeFrame: baseline and 12 months
measure: insulin like growth factor one
timeFrame: baseline and 12 months
measure: insulin like growth factor binding protein three
timeFrame: baseline and 12 months
measure: Upper limb lymphedema twenty seven
timeFrame: baseline and 12 months
measure: body image and relationship survey
timeFrame: baseline and 12 months
Other outcomes:
measure: breast cancer recurrence
timeFrame: 10 years post trial
measure: mortality
timeFrame: 10 years post trial
Locations:
city: Hershey
country: United States
facility: The Penn TREC Survivorship Center
state: Pennsylvania
Study officials:
affiliation: Penn State University
name: Kathryn H. Schmitz, MPH,PhD
role: PRINCIPAL_INVESTIGATOR
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