Early Stage Breast Cancer (Stage 0-III)
Conditions
Keywords
Breast Cancer, Exercise, CRP, C-reactive protein, BMI, Nevada Cancer Institute, Rehabilitation, Prescriptive exercise, Physical Activity, DEXA, Obesity, lifestyle intervention, Early Stage Breast Cancer Patients (stage 0-III)
Brief summary
The proposed study compares the outcomes of a physical activity intervention begun at diagnosis, continuing through active cancer treatment and into six months of survivorship compared to the outcomes of a control group receiving limited information on activity.
Detailed description
Patients (with stage 0 to stage III breast cancer)receiving chemotherapy, radiation or both chemotherapy and radiation will be included in the study.Randomization will be stratified by disease stage at diagnosis, treatment modalities planned, and hormonal status. Each patient will have a weekly goal of 2000 calories burned and 18 MET-hours of exercise which can be achieved in 4 to 7 hours of physical activity per week. Resistance training, using weight machines and aerobic training using treadmills, elliptical trainers and stationary bicycles, will be utilized in the intervention group. The control group will receive basic information on physical activity but not be instructed. Any physical activity in this group will be self-reported. Change in C-reactive protein will be the primary endpoint. Changes in other laboratory values, DEXA measurements, and quality of life measurements will be secondary endpoints.
Interventions
OTHERExercise Regimen
Exercise instruction
Sponsors
Vons
Nevada Cancer Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Consent to participate in study 2. Women aged 18 and older 3. Stage 0 to III breast cancer prior to any treatment and at time of diagnosis 4. Requires treatment that includes chemotherapy, radiation therapy or both chemotherapy and radiation therapy 5. Adequate fitness to participate in a physical activity as assessed by the investigator 6. Willing and able to participate in a prescribed exercise program
Exclusion criteria
1. Metastatic breast cancer (Stage IV) 2. Initiation of treatment regimen prior to enrollment 3. Treatment for breast cancer not requiring chemotherapy or radiation therapy 4. Patients who are pregnant (negative urine pregnancy test required at baseline to determine eligibility in women of child bearing potential). 5. Currently lactating 6. Do not read, understand, or speak English Eligible participants will not be included if they have: 1. known cardiac disease, 2. uncontrolled hypertension, 3. uncontrolled thyroid disease, 4. diabetes mellitus, 5. mental illness, 6. infection, 7. immune or endocrine abnormality, 8. body weight reduction I10% in past 6 months, and 9. positive exercise stress test. 10. Major surgery within last 6 months that requires exercise restriction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in CRP | — | The primary endpoint for this study change in C-reactive protein. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in laboratory values | — | Compare changes in: * Glucose * Insulin * Estradiol * Testosterone |
| Change in body composition | — | Body composition parameters and bone density will be assessed using Dual Energy X-ray Absorptiometry (DEXA) and compared between the two groups. |
| Quality of Life | — | Quality of Life will be measured and compared between the groups |
| Overall Survival | — | Comparing overall survival and progression free survival between groups. |
Countries
United States
Outcome results
None listed