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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Condition (as posted)
Mapped entity
Match
Confidence
Lymphedema
—
UNRESOLVED
—
Interventions
Interventions (2)
Intervention
Type
Mapped drug
Match
Exercise Intervention
Behavioral
—
UNRESOLVED
Weight Loss Intervention
Behavioral
—
UNRESOLVED
Design
Arms and outcomes
Arms (4)
type
NO_INTERVENTION
label
Lymphedema Care Only
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.
type
EXPERIMENTAL
label
Exercise only
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.
interventionNames
Behavioral: Exercise Intervention
Eligibility
Eligibility (as posted)
Sex
Female
Maximum age
80 Years
Show eligibility criteria text
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
References
Publications (113)
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type
EXPERIMENTAL
label
Weight loss only
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.
interventionNames
Behavioral: Weight Loss Intervention
type
EXPERIMENTAL
label
Exercise and Weight loss combined
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.
interventionNames
Behavioral: Exercise Intervention
Behavioral: Weight Loss Intervention
Primary outcomes (1)
measure
Percent interlimb difference, change over 12 months.
timeFrame
Baseline and 12 months
description
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 outcomes (18)
measure
Clinical Lymphedema Events
timeFrame
Data collected over the 12 month follow-up, with events collected as reported
description
Flare-ups and cellulitic infections (number and type recorded)
measure
Clinical Evaluation Score for Lymphedema
timeFrame
Baseline and 12 months
description
Standardized clinical evaluation survey completed by certified lymphatic therapists
measure
Norman Lymphedema Survey
timeFrame
Baseline and 12 months
description
Thirteen symptoms, recorded within a standardized survey (Norman Lymphedema Survey)
measure
Weight loss
timeFrame
Baseline and 12 months
description
body weight loss over 12 months
measure
Biomarkers: Estradiol
timeFrame
baseline and 12 months
description
circulating estradiol levels in the blood
measure
Biomarkers: Testosterone
timeFrame
baseline and 12 months
description
circulating testosterone levels in the blood
measure
Biomarkers - Sex Hormone Binding Globulin
timeFrame
baseline and 12 months
description
circulating sex hormone binding globulin levels in the blood
measure
Inflammation: Interleukin six
timeFrame
baseline and 12 months
description
Circulating interleukin six levels in the blood
measure
Inflammation: C reactive protein
timeFrame
baseline and 12 months
description
Circulating c reactive protein levels in the blood
measure
Adiponectin
timeFrame
baseline and 12 months
description
circulating Adiponectin levels in the blood
measure
Leptin
timeFrame
baseline and 12 months
description
circulating leptin levels in the blood
measure
F2-isoprostanes
timeFrame
baseline and 12 months
description
circulating F2-isoprostane levels in the blood
measure
Insulin
timeFrame
baseline and 12 months
description
circulating insulin levels in the blood
measure
Glucose
timeFrame
baseline and 12 months
description
circulating glucose levels in the blood
measure
insulin like growth factor one
timeFrame
baseline and 12 months
description
circulating levels of insulin like growth factor one in the blood
measure
insulin like growth factor binding protein three
timeFrame
baseline and 12 months
description
circulating levels of insulin like growth factor binding protein three in the blood
measure
Upper limb lymphedema twenty seven
timeFrame
baseline and 12 months
description
27 item survey on lymphedema quality of life
measure
body image and relationship survey
timeFrame
baseline and 12 months
description
32 item survey on body image specifically developed for breast cancer survivors
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DERIVEDSturgeon KM, Brown JC, Sears DD, Sarwer DB, Schmitz KH. WISER Survivor Trial: Combined Effect of Exercise and Weight Loss Interventions on Inflammation in Breast Cancer Survivors. Med Sci Sports Exerc. 2023 Feb 1;55(2):209-215. doi: 10.1249/MSS.0000000000003050. Epub 2022 Sep 29. PMID 36170550
DERIVEDSchmitz KH, Troxel AB, Dean LT, DeMichele A, Brown JC, Sturgeon K, Zhang Z, Evangelisti M, Spinelli B, Kallan MJ, Denlinger C, Cheville A, Winkels RM, Chodosh L, Sarwer DB. Effect of Home-Based Exercise and Weight Loss Programs on Breast Cancer-Related Lymphedema Outcomes Among Overweight Breast Cancer Survivors: The WISER Survivor Randomized Clinical Trial. JAMA Oncol. 2019 Nov 1;5(11):1605-1613. doi: 10.1001/jamaoncol.2019.2109. PMID 31415063
DERIVEDWinkels RM, Sturgeon KM, Kallan MJ, Dean LT, Zhang Z, Evangelisti M, Brown JC, Sarwer DB, Troxel AB, Denlinger C, Laudermilk M, Fornash A, DeMichele A, Chodosh LA, Schmitz KH. The women in steady exercise research (WISER) survivor trial: The innovative transdisciplinary design of a randomized controlled trial of exercise and weight-loss interventions among breast cancer survivors with lymphedema. Contemp Clin Trials. 2017 Oct;61:63-72. doi: 10.1016/j.cct.2017.07.017. Epub 2017 Jul 21. PMID 28739540
DERIVEDDean LT, Kumar A, Kim T, Herling M, Brown JC, Zhang Z, Evangelisti M, Hackley R, Kim J, Cheville A, Troxel AB, Schwartz JS, Schmitz KH. Race or Resource? BMI, Race, and Other Social Factors as Risk Factors for Interlimb Differences among Overweight Breast Cancer Survivors with Lymphedema. J Obes. 2016;2016:8241710. doi: 10.1155/2016/8241710. Epub 2016 Jun 28. PMID 27433356