Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Blood and Lymph Conditions

Recurrence

Breast Neoplasms

Body Weight

Lymphedema

Weight Loss

Lymphatic Diseases

Central Nervous System Depressants

All Drugs and Chemicals

Other Dietary Supplements

Benzocaine

Tannic Acid

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.

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.

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.

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.

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 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.

Weight Loss Intervention

Kathryn H. Schmitz, MPH,PhD

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.

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)

The Women In Steady Exercise Research (WISER) Survivor Trial

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

participants will be followed for breast cancer recurrence

participants will be followed for mortality

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

Flare-ups and cellulitic infections (number and type recorded)

Standardized clinical evaluation survey completed by certified lymphatic therapists

Thirteen symptoms, recorded within a standardized survey (Norman Lymphedema Survey)

circulating estradiol levels in the blood

circulating testosterone levels in the blood

circulating sex hormone binding globulin levels in the blood

Circulating interleukin six levels in the blood

Circulating c reactive protein levels in the blood

circulating Adiponectin levels in the blood

circulating F2-isoprostane levels in the blood

circulating levels of insulin like growth factor one in the blood

circulating levels of insulin like growth factor binding protein three in the blood

27 item survey on lymphedema quality of life

32 item survey on body image specifically developed for breast cancer survivors

Spots Global Cancer Trial Database for The Women In Steady Exercise Research (WISER) Survivor Trial

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial