The Women In Steady Exercise Research (WISER) Survivor Trial (WISER Survivor)

Penn State Health

Status: Completed

Conditions: Lymphedema

Treatments: Behavioral: Weight Loss Intervention; Behavioral: Exercise Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT01515124

U54CA155850

Details and patient eligibility

About

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.

Enrollment: 450 patients

Sex: Female

Ages: Under 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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450 participants in 4 patient groups

Lymphedema Care Only

No Intervention group

Description:

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.

Exercise only

Experimental group

Description:

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.

Treatment:

Behavioral: Exercise Intervention

Weight loss only

Experimental group

Description:

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.

Treatment:

Behavioral: Weight Loss Intervention

Exercise and Weight loss combined

Experimental group

Description:

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.

Treatment:

Behavioral: Weight Loss Intervention

Behavioral: Exercise Intervention