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| Name | Class |
|---|---|
| Vons | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | 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. |
|
| Control Group | No Intervention | The control group will receive basic information on physical activity but not be instructed. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise Regimen | Other | Exercise instruction |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in CRP | The primary endpoint for this study change in C-reactive protein. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in laboratory values | Compare changes in:
| |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
Eligible participants will not be included if they have:
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| Name | Affiliation | Role |
|---|---|---|
| Karen Milligan, MD | Nevada Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nevada Cancer Institute | Recruiting | Las Vegas | Nevada | 89135 | United States |
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| Label | URL |
|---|---|
| Nevada Cancer Institute | View source |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009043 | Motor Activity |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| 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. |
| D017437 |
| Skin and Connective Tissue Diseases |
| D001519 | Behavior |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |