Overview

This trial is active, not recruiting.

Condition lymphedema
Treatments exercise intervention, weight loss intervention
Phase phase 3
Sponsor University of Pennsylvania
Start date January 2012
End date September 2016
Trial size 555 participants
Trial identifier NCT01515124, U54CA155850

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 purpose of this study is to test the effects of these interventions on lymphedema outcomes, breast cancer recurrence and quality of life.

The cost analysis sub-study - will assess the cost-effectiveness of conducting the WISER Survivor interventions and also model the impact of the WISER Survivor interventions over an extended time frame.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose supportive care
Arm
(No Intervention)
(Experimental)
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 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.
(Experimental)
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 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.
(Experimental)
Participants in this group will receive a combination of the supervised twice-weekly weight training sessions and the weight loss program.
exercise 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.
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.

Primary Outcomes

Measure
Clinical lymphedema exacerbation rate
time frame: Baseline, 6, and 12 months

Secondary Outcomes

Measure
Quality of life outcomes
time frame: Baseline, 6, and 12 months
Biomarkers of breast cancer recurrence
time frame: Baseline and 12 months

Eligibility Criteria

Female participants of any age.

Inclusion Criteria: - breast cancer survivor - overweight or obese (BMI of 25 or greater) - must have breast cancer related lymphedema - at least 2 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 or upper 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

Additional Information

Official title The Women In Steady Exercise Research (WISER) Survivor Trial & Cost of Illness and Cost Effectiveness of Alternative Management Strategies
Principal investigator Kathryn H. Schmitz, MPH,PhD
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by University of Pennsylvania.