The Women In Steady Exercise Research (WISER) Survivor Trial
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any - 80 |
| Updated: | 1/31/2019 |
| Start Date: | January 2012 |
| End Date: | May 2016 |
The Women In Steady Exercise Research (WISER) Survivor Trial & Cost of Illness and Cost Effectiveness of Alternative Management Strategies
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.
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.
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
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