NCT00359060

Brief Summary

Purpose of the SHAPE study is to examine the effects of an 1-year exercise programme on endogenous hormone levels associated with breast cancer among sedentary postmenopausal women and whether a decrease in intra-abdominal fat is associated with a lowering of these hormone levels.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at below P25 for phase_3 breast-cancer

Timeline
Completed

Started Jan 2005

Shorter than P25 for phase_3 breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 31, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 1, 2006

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

October 13, 2006

Status Verified

July 1, 2006

First QC Date

July 31, 2006

Last Update Submit

October 12, 2006

Conditions

Breast Cancer

Keywords

Physical activitySex steroid hormonesBreast cancer riskIntervention studyPostmenopausal women

Outcome Measures

Primary Outcomes (5)

  • Serum concentrations of endogenous estrogens: estradiol (total, free), estrone, estrone sulfate

  • Serum concentrations of endogenous androgens: testosterone, androstenedione

  • Serum concentrations of sex hormone binding globulin

  • Serum concentrations of fasting insulin

  • Insulin sensitivity

Secondary Outcomes (14)

  • Amount of total body fat and intra-abdominal fat

  • Weight

  • Body Mass Index (BMI)

  • Body fat distribution

  • Waist to hip ratio

  • +9 more secondary outcomes

Interventions

Physical activityBEHAVIORAL

Eligibility Criteria

Age50 Years - 69 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women aged 50 -69 year
  • \> 12 months since last menses
  • Non-smokers (at least 12 months)
  • Sedentary
  • Knowledge of the Dutch language
  • Agreement to be randomly assigned to either the exercise intervention or control group
  • Informed consent to participate in all screening and study activities

You may not qualify if:

  • Use of hormone replacement or oral contraceptives in past 6 months
  • Morbidly obese (BMI \> 40)
  • BMI \< 22
  • Currently on or planning to go on a strict diet
  • Ever diagnosed with breast cancer
  • Diagnosis of other types of cancer in the past 5 years
  • Diabetes mellitus or other endocrine related diseases
  • Disorders or diseases (locomotor, optical, neurological, mental) that might impede the participation in the exercise programme
  • Alcohol or drug abuse
  • Maintenance use of corticosteroids
  • Use of beta blockers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Utrecht, Julius Center

Utrecht, 3508 GA, Netherlands

Location

Related Publications (1)

  • Monninkhof EM, Peeters PH, Schuit AJ. Design of the sex hormones and physical exercise (SHAPE) study. BMC Public Health. 2007 Sep 4;7:232. doi: 10.1186/1471-2458-7-232.

    PMID: 17767724DERIVED

MeSH Terms

Conditions

Breast NeoplasmsMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Jantine Schuit, PhD

    Dutch Institute of Public Health and the Environment

    PRINCIPAL INVESTIGATOR

  • Petra HM Peeters, PhD

    University Medical Center Utrecht, Julius Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 31, 2006

First Posted

August 1, 2006

Study Start

January 1, 2005

Study Completion

September 1, 2006

Last Updated

October 13, 2006

Record last verified: 2006-07

Locations

NL(1)