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Women With Cancer: An Exercise Study to Promote Health

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ClinicalTrials.gov Identifier: NCT01102985
Recruitment Status : Completed
First Posted : April 13, 2010
Last Update Posted : July 1, 2015
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Yale University

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.

Condition or disease Intervention/treatment
Bone Loss Cancer Behavioral: aerobic resistance exercise Behavioral: home based health promotion

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).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 154 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: An Exercise Intervention to Improve Health in Postmenopausal Cancer Survivors
Study Start Date : January 2008
Primary Completion Date : March 2013
Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: aerobic resistance
12 month aerobic resistance exercise at a fitness center
Behavioral: aerobic resistance exercise
three times per week aerobic resistance exercise for 12 months
Other Name: physical activity
Active Comparator: home based physical activity
national recommendations for physical activity for adults
Behavioral: home based health promotion
education and support to adapt national guidelines for 30 minutes physical activity most days of the week
Other Name: health promotion



Primary Outcome Measures :
  1. Bone mass-lumbar spine and hip (DEXA) [ Time Frame: 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 Outcome Measures :
  1. body composition-% fat mass, % lean muscle mass (whole body DEXA) [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female
  • Cancer diagnosis
  • Postmenopausal

Exclusion Criteria:

  • Health condition contraindication to moderate physical activity

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01102985


Locations
United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06536-0740
Sponsors and Collaborators
Yale University
National Cancer Institute (NCI)
Investigators
Principal Investigator: M. Tish Knobf, PhD Yale University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01102985     History of Changes
Other Study ID Numbers: 0801003383
1R01CA122658-01A2 ( U.S. NIH Grant/Contract )
First Posted: April 13, 2010    Key Record Dates
Last Update Posted: July 1, 2015
Last Verified: June 2015

Keywords provided by Yale University:
exercise
physical activity
intervention
cancer survivor