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

October 6, 2022 updated by: Milton S. Hershey Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

450

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • The Penn TREC Survivorship Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 80 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Lymphedema Care Only

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.
EXPERIMENTAL: Exercise only
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.
Behavioral: 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: Weight loss only
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.
Behavioral: 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: Exercise and Weight loss combined
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.
Behavioral: 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.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent interlimb difference, change over 12 months.
Time Frame: Baseline and 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
Baseline and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Lymphedema Events
Time Frame: Data collected over the 12 month follow-up, with events collected as reported
Flare-ups and cellulitic infections (number and type recorded)
Data collected over the 12 month follow-up, with events collected as reported
Clinical Evaluation Score for Lymphedema
Time Frame: Baseline and 12 months
Standardized clinical evaluation survey completed by certified lymphatic therapists
Baseline and 12 months
Norman Lymphedema Survey
Time Frame: Baseline and 12 months
Thirteen symptoms, recorded within a standardized survey (Norman Lymphedema Survey)
Baseline and 12 months
Weight loss
Time Frame: Baseline and 12 months
body weight loss over 12 months
Baseline and 12 months
Biomarkers: Estradiol
Time Frame: baseline and 12 months
circulating estradiol levels in the blood
baseline and 12 months
Biomarkers: Testosterone
Time Frame: baseline and 12 months
circulating testosterone levels in the blood
baseline and 12 months
Biomarkers - Sex Hormone Binding Globulin
Time Frame: baseline and 12 months
circulating sex hormone binding globulin levels in the blood
baseline and 12 months
Inflammation: Interleukin six
Time Frame: baseline and 12 months
Circulating interleukin six levels in the blood
baseline and 12 months
Inflammation: C reactive protein
Time Frame: baseline and 12 months
Circulating c reactive protein levels in the blood
baseline and 12 months
Adiponectin
Time Frame: baseline and 12 months
circulating Adiponectin levels in the blood
baseline and 12 months
Leptin
Time Frame: baseline and 12 months
circulating leptin levels in the blood
baseline and 12 months
F2-isoprostanes
Time Frame: baseline and 12 months
circulating F2-isoprostane levels in the blood
baseline and 12 months
Insulin
Time Frame: baseline and 12 months
circulating insulin levels in the blood
baseline and 12 months
Glucose
Time Frame: baseline and 12 months
circulating glucose levels in the blood
baseline and 12 months
insulin like growth factor one
Time Frame: baseline and 12 months
circulating levels of insulin like growth factor one in the blood
baseline and 12 months
insulin like growth factor binding protein three
Time Frame: baseline and 12 months
circulating levels of insulin like growth factor binding protein three in the blood
baseline and 12 months
Upper limb lymphedema twenty seven
Time Frame: baseline and 12 months
27 item survey on lymphedema quality of life
baseline and 12 months
body image and relationship survey
Time Frame: baseline and 12 months
32 item survey on body image specifically developed for breast cancer survivors
baseline and 12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
breast cancer recurrence
Time Frame: 10 years post trial
participants will be followed for breast cancer recurrence
10 years post trial
mortality
Time Frame: 10 years post trial
participants will be followed for mortality
10 years post trial

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Milton S. Hershey Medical Center

Investigators

  • Principal Investigator: Kathryn H. Schmitz, MPH,PhD, Penn State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2012

Primary Completion (ACTUAL)

May 1, 2016

Study Completion (ACTUAL)

May 1, 2016

Study Registration Dates

First Submitted

January 18, 2012

First Submitted That Met QC Criteria

January 18, 2012

First Posted (ESTIMATE)

January 23, 2012

Study Record Updates

Last Update Posted (ACTUAL)

October 10, 2022

Last Update Submitted That Met QC Criteria

October 6, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U54CA155850 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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