Women With Cancer: An Exercise Study to Promote Health

Study Overview
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Brief Summary
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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
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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).

Official Title
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An Exercise Intervention to Improve Health in Postmenopausal Cancer Survivors

Conditions
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Bone Loss, Cancer

Intervention / Treatment
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* Behavioral: aerobic resistance exercise
* Behavioral: home based health promotion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female Cancer diagnosis Postmenopausal Exclusion Criteria: Health condition contraindication to moderate physical activity

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: aerobic resistance<br>12 month aerobic resistance exercise at a fitness center | Behavioral: aerobic resistance exercise<br>* three times per week aerobic resistance exercise for 12 months<br>* Other names: physical activity;|
| Active Comparator: home based physical activity<br>national recommendations for physical activity for adults | Behavioral: home based health promotion<br>* education and support to adapt national guidelines for 30 minutes physical activity most days of the week<br>* Other names: health promotion;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body composition-% fat mass, % lean muscle mass (whole body DEXA) | Body composition will be assessed by waist circumference and whole body DEXA scan (% fat mass, % lean muscle mass) at baseline, 6 and 12 months | baseline, 6, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exercise, physical activity, intervention, cancer survivor