The Women In Steady Exercise Research (WISER) Survivor Trial

NCT01515124 | Completed DMC

• 1 other identifier: U54CA155850
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphedema

Keywords

Lymphedema; Strength training intervention; Weight loss intervention; Breast cancer recurrence; Cost Effectiveness

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline and 12 months

Secondary Outcomes (18)

• Clinical Lymphedema Events

  Data collected over the 12 month follow-up, with events collected as reported

• Clinical Evaluation Score for Lymphedema

  Baseline and 12 months

• Norman Lymphedema Survey

  Baseline and 12 months

• Weight loss

  Baseline and 12 months

• Biomarkers: Estradiol

  baseline and 12 months

Other Outcomes (2)

• breast cancer recurrence

  10 years post trial

• mortality

  10 years post trial

Study Arms (4)

Lymphedema Care Only

NO INTERVENTION

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

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

Weight loss only

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 only group members also received the Lymphedema care intervention described above.

Behavioral: Weight Loss Intervention

Exercise and Weight loss combined

EXPERIMENTAL

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; Behavioral: Weight Loss Intervention

Interventions

Exercise Intervention BEHAVIORAL

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.

Exercise and Weight loss combined; Exercise only

Weight Loss Intervention BEHAVIORAL

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.

Exercise and Weight loss combined; Weight loss only

Eligibility Criteria

• Age: Up to 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

The Penn TREC Survivorship Center

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (113)

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  PMID: 36170550 DERIVED

• Schmitz 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.

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• Winkels 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 DERIVED

• Dean 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 DERIVED

MeSH Terms

Conditions

Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Kathryn H. Schmitz, MPH,PhD

  Penn State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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)
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2012
• First Posted: January 23, 2012
• Study Start: January 1, 2012
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: October 10, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)