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Trial record 1 of 1 for:    NCT01515124
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The Women In Steady Exercise Research (WISER) Survivor Trial (WISER Survivor)

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ClinicalTrials.gov Identifier: NCT01515124
Recruitment Status : Completed
First Posted : January 23, 2012
Last Update Posted : June 24, 2019
Sponsor:
Information provided by (Responsible Party):
Kathryn Schmitz, Milton S. Hershey Medical Center

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.

Condition or disease Intervention/treatment Phase
Lymphedema Behavioral: Exercise Intervention Behavioral: Weight Loss Intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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)
Primary Purpose: Supportive Care
Official Title: The Women In Steady Exercise Research (WISER) Survivor Trial & Cost of Illness and Cost Effectiveness of Alternative Management Strategies
Actual Study Start Date : January 2012
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016


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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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)

  2. Clinical Evaluation Score for Lymphedema [ Time Frame: Baseline and 12 months ]
    Standardized clinical evaluation survey completed by certified lymphatic therapists

  3. Norman Lymphedema Survey [ Time Frame: Baseline and 12 months ]
    Thirteen symptoms, recorded within a standardized survey (Norman Lymphedema Survey)

  4. Weight loss [ Time Frame: Baseline and 12 months ]
    body weight loss over 12 months

  5. Biomarkers: Estradiol [ Time Frame: baseline and 12 months ]
    circulating estradiol levels in the blood

  6. Biomarkers: Testosterone [ Time Frame: baseline and 12 months ]
    circulating testosterone levels in the blood

  7. Biomarkers - Sex Hormone Binding Globulin [ Time Frame: baseline and 12 months ]
    circulating sex hormone binding globulin levels in the blood

  8. Inflammation: Interleukin six [ Time Frame: baseline and 12 months ]
    Circulating interleukin six levels in the blood

  9. Inflammation: C reactive protein [ Time Frame: baseline and 12 months ]
    Circulating c reactive protein levels in the blood

  10. Adiponectin [ Time Frame: baseline and 12 months ]
    circulating Adiponectin levels in the blood

  11. Leptin [ Time Frame: baseline and 12 months ]
    circulating leptin levels in the blood

  12. F2-isoprostanes [ Time Frame: baseline and 12 months ]
    circulating F2-isoprostane levels in the blood

  13. Insulin [ Time Frame: baseline and 12 months ]
    circulating insulin levels in the blood

  14. Glucose [ Time Frame: baseline and 12 months ]
    circulating glucose levels in the blood

  15. insulin like growth factor one [ Time Frame: baseline and 12 months ]
    circulating levels of insulin like growth factor one in the blood

  16. 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

  17. Upper limb lymphedema twenty seven [ Time Frame: baseline and 12 months ]
    27 item survey on lymphedema quality of life

  18. body image and relationship survey [ Time Frame: baseline and 12 months ]
    32 item survey on body image specifically developed for breast cancer survivors


Other Outcome Measures:
  1. breast cancer recurrence [ Time Frame: 10 years post trial ]
    participants will be followed for breast cancer recurrence

  2. mortality [ Time Frame: 10 years post trial ]
    participants will be followed for mortality



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   up to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01515124


Locations
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United States, Pennsylvania
The Penn TREC Survivorship Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
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Principal Investigator: Kathryn H. Schmitz, MPH,PhD Penn State University

Publications:
Hewitt M, Greenfield, S., Stovall, E. , ed. From Cancer Patient to Cancer Survivor: Lost in Transition. Washington, D.C.: National Academies Press; 2006.
Cheville A. Patient perceptions of lymphedema maintenance therapy: is the cure worse than the condition? In: American Academy of Physical Medicine and Rehabilitation Orlando, FL; 2002.
Derbas J, Vetter, M., Volger, S., Khan, Z., Panigrahi, E., Tsai, A.G., Sarwer, D.B., Wadden, T.A. Improving Weight Management in Primary Care Practice: A Possible Role for Auxiliary Health Professionals Collaborating with Primary Care Physicians. Obesity and Weight Management 2009;5:210-5.
Klemp JK CS, Papsek S, et al. . Feasibility of a diet, exercise, and behavior modification intervention for post-menopausal breast cancer survivors. . Cancer Res 2009;67(24):557S.
NLN Medical Advisory Commitee. Position Statement of the National Lymphedema Network. Topic: Lymphedema Risk Reduction Practices. In; 2005:1-2.
Földi M, Földi, E., Strössenreuther, R.H.K., Kubik, S. Foldi's Textbook of Lymphology for Physicians and Lymphedema Therapists: For Physicians and Lymphedema Therapists. 2nd ed. Munich: Elsevier,Urban&FischerVerlag; 2006.
Consensus Document on the Management of Cellulitis in Lymphoedema. British Lymphology Society and the Lymphedema Support Network, 2007. (Accessed October 26, 2009, at http://www.lymphoedema.org/lsn/consensus_on_cellulitis_dec_06.pdf.)
Topic: Training of Lymphedema Therapists. National Lymphedema Network National Advisory Committee, 2005. (Accessed Access Date: September 17, 2008, 2008, at http://www.lymphnet.org/lymphedemaFAQs/positionPapers.htm.)
Coutts F, Grainger, A, Bulley, C. Perometer (400T) measurement of lower limb volume: Development of a standardised protocol. Physiotherapy 2007;93(Suppl 1):S670.
Fleck S, Kraemer W. Designing resistance training programs. 2nd ed. Champaign, IL: Human Kinetics; 1997.
Launois R, Mègnigbêto, A.C., Pocquet, K.,Alliot, F. A specific quality of life scale in upper limb lymphedema: the ULL-27 questionnaire. Lymphology 2002;35(Suppl):181-7.
Holm S. A simple sequentially rejective multiple test procedure. Scandinavian Journal of Statistics 1979;6:65-70.
Hochberg Y. A sharper Bonferroni procedure for multiple tests of significance. Biometrika 1988;75:800-802.
Singer J, Willett J. Applied Longitudinal Data Analysis. New York: Oxford University Press; 2003.
Fitzmaurice G, Laird N, Ware J. Applied Longitudinal Analysis. Hoboken, New Jersey: Wiley; 2004.
Troxel A. An index of local sensitivity to nonignorability. Statistica Sinica 2004;14:1221-37.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kathryn Schmitz, Professor, Public Health Sciences, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT01515124     History of Changes
Other Study ID Numbers: U54CA155850 ( U.S. NIH Grant/Contract )
First Posted: January 23, 2012    Key Record Dates
Last Update Posted: June 24, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kathryn Schmitz, Milton S. Hershey Medical Center:
Lymphedema
Strength training intervention
Weight loss intervention
Breast cancer recurrence
Cost Effectiveness
Additional relevant MeSH terms:
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Lymphedema
Lymphatic Diseases