Women With Cancer: An Exercise Study to Promote Health

Cancer Clinical Trial

Official title:

An Exercise Intervention to Improve Health in Postmenopausal Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01102985
• Other study ID #: 0801003383
• Secondary ID: 1R01CA122658-01A
• Status: Completed
• Phase: N/A
• First received: January 19, 2010
• Last updated: June 30, 2015
• Start date: January 2008
• Est. completion date: March 2013

Study information

• Verified date: June 2015
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Female

• Cancer diagnosis

• Postmenopausal

Exclusion Criteria:

• Health condition contraindication to moderate physical activity

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Bone Loss
• Cancer

Intervention

Behavioral:
• aerobic resistance exercise
three times per week aerobic resistance exercise for 12 months
• home based health promotion
education and support to adapt national guidelines for 30 minutes physical activity most days of the week

Locations

Country	Name	City	State
United States	Yale University	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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	No