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Completed

NCT Number: NCT01515124

The Women In Steady Exercise Research (WISER) Survivor Trial

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.

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Key information

Conditions

Lymphedema Hemic and Lymphatic Diseases Lymphatic Diseases

Age range

Up to 80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The Penn TREC Survivorship Center

Hershey, Pennsylvania, 17033, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Registry information

Official study title

The Women In Steady Exercise Research (WISER) Survivor Trial & Cost of Illness and Cost Effectiveness of Alternative Management Strategies

Acronym: WISER Survivor

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Jan 23, 2012
Registry last updated
Oct 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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