Back to resultsThe Women In Steady Exercise Research (WISER) Survivor Trial (WISER Survivor)
Primary Purpose
Lymphedema
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise Intervention
Weight Loss Intervention
Sponsored by
About this trial
This is an interventional supportive care trial for Lymphedema focused on measuring Lymphedema, Strength training intervention, Weight loss intervention, Breast cancer recurrence, Cost Effectiveness
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
Sites / Locations
- The Penn TREC Survivorship Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
No Intervention
Experimental
Experimental
Experimental
Arm Label
Lymphedema Care Only
Exercise only
Weight loss only
Exercise and Weight loss combined
Arm Description
All 4 groups receive lymphedema care as follows: 2 custom fitted compression garments (baseline and 6 months) evaluations for flare-ups at request (and at each measurement time point) 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.
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.
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.
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.
Outcomes
Primary Outcome Measures
Percent interlimb difference, change over 12 months.
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 Outcome Measures
Clinical Lymphedema Events
Flare-ups and cellulitic infections (number and type recorded)
Clinical Evaluation Score for Lymphedema
Standardized clinical evaluation survey completed by certified lymphatic therapists
Norman Lymphedema Survey
Thirteen symptoms, recorded within a standardized survey (Norman Lymphedema Survey)
Weight loss
body weight loss over 12 months
Biomarkers: Estradiol
circulating estradiol levels in the blood
Biomarkers: Testosterone
circulating testosterone levels in the blood
Biomarkers - Sex Hormone Binding Globulin
circulating sex hormone binding globulin levels in the blood
Inflammation: Interleukin six
Circulating interleukin six levels in the blood
Inflammation: C reactive protein
Circulating c reactive protein levels in the blood
Adiponectin
circulating Adiponectin levels in the blood
Leptin
circulating leptin levels in the blood
F2-isoprostanes
circulating F2-isoprostane levels in the blood
Insulin
circulating insulin levels in the blood
Glucose
circulating glucose levels in the blood
insulin like growth factor one
circulating levels of insulin like growth factor one in the blood
insulin like growth factor binding protein three
circulating levels of insulin like growth factor binding protein three in the blood
Upper limb lymphedema twenty seven
27 item survey on lymphedema quality of life
body image and relationship survey
32 item survey on body image specifically developed for breast cancer survivors
Full Information
NCT ID
NCT01515124
First Posted
January 18, 2012
Last Updated
October 6, 2022
Sponsor
Milton S. Hershey Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01515124
Brief Title
The Women In Steady Exercise Research (WISER) Survivor Trial
Acronym
WISER Survivor
Official Title
The Women In Steady Exercise Research (WISER) Survivor Trial & Cost of Illness and Cost Effectiveness of Alternative Management Strategies
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
January 2012 (Actual)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Milton S. Hershey Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphedema
Keywords
Lymphedema, Strength training intervention, Weight loss intervention, Breast cancer recurrence, Cost Effectiveness
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
All participants asked at the start of each measurement encounter not to inform measurement staff of their randomization group status. All measurement staff asked to guess group status at end of each measurement encounter. Patterns of responses beyond chance result in corrective action to improve masking (e.g.; requests from PI for participants to mask group status)
Allocation
Randomized
Enrollment
450 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lymphedema Care Only
Arm Type
No Intervention
Arm Description
All 4 groups receive lymphedema care as follows:
2 custom fitted compression garments (baseline and 6 months)
evaluations for flare-ups at request (and at each measurement time point)
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.
Arm Title
Exercise only
Arm Type
Experimental
Arm 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.
Arm Title
Weight loss only
Arm Type
Experimental
Arm 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.
Arm Title
Exercise and Weight loss combined
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Exercise Intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Weight Loss Intervention
Intervention 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.
Primary Outcome Measure Information:
Title
Percent interlimb difference, change over 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
Time Frame
Baseline and 12 months
Secondary Outcome Measure Information:
Title
Clinical Lymphedema Events
Description
Flare-ups and cellulitic infections (number and type recorded)
Time Frame
Data collected over the 12 month follow-up, with events collected as reported
Title
Clinical Evaluation Score for Lymphedema
Description
Standardized clinical evaluation survey completed by certified lymphatic therapists
Time Frame
Baseline and 12 months
Title
Norman Lymphedema Survey
Description
Thirteen symptoms, recorded within a standardized survey (Norman Lymphedema Survey)
Time Frame
Baseline and 12 months
Title
Weight loss
Description
body weight loss over 12 months
Time Frame
Baseline and 12 months
Title
Biomarkers: Estradiol
Description
circulating estradiol levels in the blood
Time Frame
baseline and 12 months
Title
Biomarkers: Testosterone
Description
circulating testosterone levels in the blood
Time Frame
baseline and 12 months
Title
Biomarkers - Sex Hormone Binding Globulin
Description
circulating sex hormone binding globulin levels in the blood
Time Frame
baseline and 12 months
Title
Inflammation: Interleukin six
Description
Circulating interleukin six levels in the blood
Time Frame
baseline and 12 months
Title
Inflammation: C reactive protein
Description
Circulating c reactive protein levels in the blood
Time Frame
baseline and 12 months
Title
Adiponectin
Description
circulating Adiponectin levels in the blood
Time Frame
baseline and 12 months
Title
Leptin
Description
circulating leptin levels in the blood
Time Frame
baseline and 12 months
Title
F2-isoprostanes
Description
circulating F2-isoprostane levels in the blood
Time Frame
baseline and 12 months
Title
Insulin
Description
circulating insulin levels in the blood
Time Frame
baseline and 12 months
Title
Glucose
Description
circulating glucose levels in the blood
Time Frame
baseline and 12 months
Title
insulin like growth factor one
Description
circulating levels of insulin like growth factor one in the blood
Time Frame
baseline and 12 months
Title
insulin like growth factor binding protein three
Description
circulating levels of insulin like growth factor binding protein three in the blood
Time Frame
baseline and 12 months
Title
Upper limb lymphedema twenty seven
Description
27 item survey on lymphedema quality of life
Time Frame
baseline and 12 months
Title
body image and relationship survey
Description
32 item survey on body image specifically developed for breast cancer survivors
Time Frame
baseline and 12 months
Other Pre-specified Outcome Measures:
Title
breast cancer recurrence
Description
participants will be followed for breast cancer recurrence
Time Frame
10 years post trial
Title
mortality
Description
participants will be followed for mortality
Time Frame
10 years post trial
10. Eligibility
Sex
Female
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathryn H. Schmitz, MPH,PhD
Organizational Affiliation
Penn State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Penn TREC Survivorship Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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