Bone Loss, Cancer
Conditions
Keywords
exercise, physical activity, intervention, cancer survivor
Brief summary
The purpose of the study is to evaluate the effect of an aerobic-resistance exercise program compared to a home based physical activity program on bone mass, body composition, metabolic risk factors and cardiovascular fitness in women with cancer who have completed therapy.
Detailed description
The proposed study will evaluate an endurance-resistive exercise intervention to attenuate the effects of menopause and cancer treatment (bone loss, increased body fat, decreased lean muscle mass, weight gain, decreased physical activity) in an at-risk population of female cancer survivors. Women with solid tumors (breast, gynecological, colo-rectal) and lymphoma who have completed primary and/or adjuvant therapy within the past three years and who are perimenopausal or early postmenopausal and any woman on an Aromatase Inhibitor will be recruited to participate in a randomized controlled trial (RCT) of a 12 month exercise intervention (N=75) versus a health promotion control group (N=75). The specific aims of the study are to: (1) examine the effects of an exercise intervention on bone mass (serum biomarkers, lumbar spine, hip DEXA) and body composition (whole body DEXA, weight, waist circumference), (2) examine the effect of an exercise intervention on metabolic risk factors (lipids, cholesterol, fasting glucose, insulin resistance, Hemoglobin A1-C, and blood pressure), and (3) examine the effects of an exercise intervention on functional status and cardiovascular fitness (exercise stress test).
Interventions
BEHAVIORALaerobic resistance exercise
three times per week aerobic resistance exercise for 12 months
BEHAVIORALhome based health promotion
education and support to adapt national guidelines for 30 minutes physical activity most days of the week
Sponsors
National Cancer Institute (NCI)
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Female * Cancer diagnosis * Postmenopausal
Exclusion criteria
* Health condition contraindication to moderate physical activity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bone mass-lumbar spine and hip (DEXA) | baseline, 12 months | Serum biomarkers for bone (serum NTX and serum osteocalcin) will be drawn at baseline, 6 and 12 months. Bone mass for lumbar spine and hip will be measured by DEXA scan at baseline and 12 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| body composition-% fat mass, % lean muscle mass (whole body DEXA) | baseline, 6, 12 months | Body composition will be assessed by waist circumference and whole body DEXA scan (% fat mass, % lean muscle mass) at baseline, 6 and 12 months |
Countries
United States
Outcome results
None listed