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OpenTrials
Completed

NCT Number: NCT01498536

Effect of Diet and Exercise in Breast Cancer Survivors

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

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Key information

Conditions

Breast Cancer Body Weight Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

West Virginia University

Morgantown, West Virginia, 26506, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • stage IV cancer

Treatment and study plan

Aerobic Exercise

Behavioral

3 times per week for 12-weeks

Primary outcomes

  1. weight loss

    Time frame: 12 weeks

    aim for loss of 10% of BMI

  2. quality of life

    Time frame: 12 weeks

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

Secondary outcomes

  1. markers of inflammation

    Time frame: 12 weeks

    blood draws at beginning and end of study to analyze any effect on inflammation

Sponsors and collaborators

Lead sponsor

West Virginia University

Other

Registry information

Official study title

Fit for the Fight: Effect of a Multidisciplinary Diet and Exercise Program on Body Weight, Quality of Life and Inflammation in Survivors of Triple-negative Breast Cancer

Acronym: F4F tri neg

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Dec 23, 2011
Registry last updated
Oct 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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