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An Exercise Intervention to Improve Health in Postmenopausal Cancer Survivors

18 Years
75 Years
Open (Enrolling)
Bone Loss, Cancer

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Trial Information

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).

Inclusion Criteria:

- Female

- Cancer diagnosis

- Postmenopausal

Exclusion Criteria:

- Health condition contraindication to moderate physical activity

Type of Study:


Study Design:

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

Outcome Measure:

Bone mass-lumbar spine and hip (DEXA)

Outcome Description:

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.

Outcome Time Frame:

baseline, 12 months

Safety Issue:


Principal Investigator

M. Tish Knobf, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Yale University


United States: Institutional Review Board

Study ID:




Start Date:

January 2008

Completion Date:

August 2012

Related Keywords:

  • Bone Loss
  • Cancer
  • exercise
  • physical activity
  • intervention
  • cancer survivor



Yale University New Haven, Connecticut  06520