Nutritional and Metabolic Diseases

Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Overweight

Recurrence

Breast Neoplasms

Obesity

Body Weight

Weight Loss

Breast Diseases

Skin Diseases

Participants randomized to the TLI condition will receive a 3-month weight management program tailored to the specific needs of women in remission from breast cancer.

Participants randomized to the CWLP condition will receive a 3-month commercial weight loss program (i.e., Weight Watchers) at no cost.

The intervention is a nutrition, physical activity, and behavioral weight management program that is tailored to the specific needs of breast cancer survivors.

Tailored Lifestyle Intervention (TLI)

This intervention is a generic, widely-available weight management program.

Commercial Weight Loss Program (CWLP)

Anne Mathews, PhD, RD

Breast cancer risk, and risk of related health problems (e.g., heart disease), is highest among women with a history of breast cancer (stages 1-3) who are also overweight or obese. The purpose of this study is to compare a tailored nutrition, physical activity, and behavioral weight management program for breast cancer survivors against a widely available commercial weight management program. We hypothesize that an intervention tailored to the unique psychological, nutritional and physical needs of breast cancer survivors will provide superior physiological and psychological benefits compared to an existing commercial program.

My Lifestyle Intervention of Food and Exercise

Preventing Breast Cancer Recurrence Through a Tailored Lifestyle Intervention.

HgA1c and fasting glucose to assess blood glucose control

National Cancer Institute's Automated Self-Administered 24-hour recall system (ASA-24)will be utilized to assess dietary intake.

Body composition will be assessed using air displacement plethysmography (Bodpod, COSMED, Inc).

Waist circumference will be measured in triplicate at the top of the iliac crest using a tension controlled tape measure upon exhalation.

Sagittal abdominal diameter will be measured in triplicate using a Holtain Kahn caliper at the top of the iliac crest upon exhalation.

Physical activity will be assessed using both objective measurement (via triaxial accelerometer) and subjective assessment (via the International Physical Activity Questionnaire, or IPAQ).

Health-related quality of life will be assessed using the European Organization of Research and Treatment of Cancer - Quality of Life (QLQ-30) and the breast-cancer specific addendum (BR-23).

Self-efficacy to abstain from eating in a variety of situations will be assessed using the Weight Efficacy Lifestyle (WEL) questionnaire.

The frequency of participants' utilization of specific weight management strategies will be assessed using the Weight Management Questionnaire (WMQ).

Height will be assessed in order to determine BMI.

Systolic and diastolic blood pressure will be assessed at each time point using an appropriately sized cuff after the participant has been sitting quietly for at least 10 minutes.

University of Florida

Disease Progression

All Drugs and Chemicals

Phytoestrogens

Miriam V Dwek, PhD

Diet has been found to influence hormone production and metabolism which in turn could affect the incidence of hormone related cancers. Consumption of soy-containing foods, known to be rich in phytoestrogens, is thought to be one of the chemoprotective factors against breast cancer in Asian populations. Phytoestrogens have a wide range of metabolic effects and may have a role in effecting breast cancer risk. Although there is mounting evidence of the positive influence of phytoestrogens on breast cancer risk, very little research has been carried out in humans as to the effects of phytoestrogens on breast cancer recurrence and survival. The DietCompLyf study aims to explore this effect by carrying out an observational study in 3,000 breast cancer women in the UK. The effects of diet, lifestyle practices and use of complementary treatments will also be investigated. Participants are recruited 9-15 months post-diagnosis and followed up for 5 years. Questionnaires as well as blood and urine samples are collected annually.

Women matching the eligibility criteria are consented at breast cancer follow-up hospital visits. Blood and urine samples are then collected and questionnaires are provided for the participants to take away and return within 4 weeks. The process of sample collection and questionnaire provision is repeated for visit at years 3 and 5.

Year 2 and 4 study visit vary in that questionnaires including a 7 day food diary are sent to participants at home to be filled in 7 days before their scheduled follow-up appointment. At hospital, blood and urine samples are collected as usual.

The Role of Diet and Lifestyle in Breast Cancer Survival

The Role of Diet, Complementary Treatment and Lifestyle in Breast Cancer Progression and Survival

United Kingdom Clinical Research Collaboration

University College London Hospitals

Director of Research and Developement

Blood and Lymph Conditions

Lymphedema

Lymphatic Diseases

Central Nervous System Depressants

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
My Lifestyle Intervention of Food and Exercise	NCT01630499	Breast Cancer	Tailored Lifest... Commercial Weig...	21 Years - 65 Years	University of Florida
The Role of Diet and Lifestyle in Breast Cancer Survival	NCT00701584	Breast Cancer		18 Years - 75 Years	University College London Hospitals
The Women In Steady Exercise Research (WISER) Survivor Trial	NCT01515124	Lymphedema	Exercise Interv... Weight Loss Int...	- 80 Years	Milton S. Hershey Medical Center

Spots Global Cancer Trial Database for breast cancer recurrence