NCT01498536

Brief Summary

This study seeks to see if a 12-week diet and exercise program improves exercise ability, energy level, and quality of life.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Jul 2011

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

July 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 23, 2011

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

October 30, 2013

Status Verified

October 1, 2013

Enrollment Period

2.1 years

First QC Date

December 20, 2011

Last Update Submit

October 29, 2013

Conditions

Breast CancerObesity

Outcome Measures

Primary Outcomes (2)

  • weight loss

    aim for loss of 10% of BMI

    12 weeks

  • quality of life

    Fatigue, disease-specific symptoms, depression and energy level all assessed by standardized questionnaires

    12 weeks

Secondary Outcomes (1)

  • markers of inflammation

    12 weeks

Interventions

aerobic exerciseBEHAVIORAL

3 times per week for 12-weeks

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ER/PR/HER2neu negative breast cancer
  • at least 3 months after end of treatment
  • BMI at least 25

You may not qualify if:

  • stage IV cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsObesity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 20, 2011

First Posted

December 23, 2011

Study Start

July 1, 2011

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

October 30, 2013

Record last verified: 2013-10

Locations

US(1)