An Exercise Intervention to Improve Health in Postmenopausal Cancer Survivors
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).
Interventional
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Bone mass-lumbar spine and hip (DEXA)
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.
baseline, 12 months
No
M. Tish Knobf, PhD
Principal Investigator
Yale University
United States: Institutional Review Board
0801003383
NCT01102985
January 2008
August 2012
Name | Location |
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Yale University | New Haven, Connecticut 06520 |