The Women In Steady Exercise Research (WISER) Survivor Trial

Lymphedema Clinical Trial

— WISER Survivor  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01515124
• Other study ID #: U54CA155850
• Status: Completed
• Phase: N/A
• Start date: January 2012
• Est. completion date: May 2016

Study information

• Verified date: October 2022
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Lymphedema

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	The Penn TREC Survivorship Center	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

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* Note: There are 109 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	breast cancer recurrence	participants will be followed for breast cancer recurrence	10 years post trial
Other	mortality	participants will be followed for mortality	10 years post trial
Primary	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	Clinical Lymphedema Events	Flare-ups and cellulitic infections (number and type recorded)	Data collected over the 12 month follow-up, with events collected as reported
Secondary	Clinical Evaluation Score for Lymphedema	Standardized clinical evaluation survey completed by certified lymphatic therapists	Baseline and 12 months
Secondary	Norman Lymphedema Survey	Thirteen symptoms, recorded within a standardized survey (Norman Lymphedema Survey)	Baseline and 12 months
Secondary	Weight loss	body weight loss over 12 months	Baseline and 12 months
Secondary	Biomarkers: Estradiol	circulating estradiol levels in the blood	baseline and 12 months
Secondary	Biomarkers: Testosterone	circulating testosterone levels in the blood	baseline and 12 months
Secondary	Biomarkers - Sex Hormone Binding Globulin	circulating sex hormone binding globulin levels in the blood	baseline and 12 months
Secondary	Inflammation: Interleukin six	Circulating interleukin six levels in the blood	baseline and 12 months
Secondary	Inflammation: C reactive protein	Circulating c reactive protein levels in the blood	baseline and 12 months
Secondary	Adiponectin	circulating Adiponectin levels in the blood	baseline and 12 months
Secondary	Leptin	circulating leptin levels in the blood	baseline and 12 months
Secondary	F2-isoprostanes	circulating F2-isoprostane levels in the blood	baseline and 12 months
Secondary	Insulin	circulating insulin levels in the blood	baseline and 12 months
Secondary	Glucose	circulating glucose levels in the blood	baseline and 12 months
Secondary	insulin like growth factor one	circulating levels of insulin like growth factor one in the blood	baseline and 12 months
Secondary	insulin like growth factor binding protein three	circulating levels of insulin like growth factor binding protein three in the blood	baseline and 12 months
Secondary	Upper limb lymphedema twenty seven	27 item survey on lymphedema quality of life	baseline and 12 months
Secondary	body image and relationship survey	32 item survey on body image specifically developed for breast cancer survivors	baseline and 12 months