Nutrition, Physical Activity, and Cognition in Breast Cancer Survivors

Breast Cancer Clinical Trial

Official title:

Lifestyle Factors, Inflammation, and Cognition in Breast Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02591316
• Other study ID #: 2014T34
• Status: Completed
• Phase: N/A
• First received: October 27, 2015
• Last updated: July 17, 2016
• Start date: February 2015
• Est. completion date: May 2016

Study information

• Verified date: July 2016
• Source: Texas State University, San Marcos
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to examine the relationship between nutrition, physical activity and brain function in breast cancer survivors.

Description:

The current study will examine the potential relationships between physical activity, dietary intake, body composition and cognition in breast cancer cancer survivors and age-matched women without a previous cancer diagnosis. Additionally, we will measure blood inflammatory markers to explore the relationship between lifestyle factors and inflammation.

The study involves two, 1hr appointments at Texas State University. The first visit will include cognitive testing and body composition assessment. Participants will be given an activity monitor to wear for one week and a packet of questionnaires to complete at home. At the second visit, a fasted blood sample will be collected, and participants will complete a food frequency questionnaire.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 70 Years

Eligibility

Inclusion Criteria:

• Breast cancer survivors must have completed primary treatment (chemotherapy, radiation therapy or both) within past 60 months

• age-matched controls must have no previous cancer diagnosis

• Female

• no history of stroke, heart attack or transient ischemic attack

• not currently pregnant; can speak, read, and write English

• can attend all testing sessions

• not blind or legally blind; nonsmoker

• no current use of computer-based brain training games (e.g. Lumosity ®, BrainHQ ®).

Exclusion Criteria:

• male

• < 30 or > 70 years of age

• breast cancer survivor > 60 months from last treatment or currently undergoing primary treatment

• breast cancer survivor never treated with chemotherapy and/or radiation

• previous cancer diagnosis other than breast cancer

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Cognition
• Cognition Disorders
• Cognitive Impairment

Intervention

Other:
• no intervention

Locations

Country	Name	City	State
United States	Texas State University	San Marcos	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas State University, San Marcos

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Medical History	Self-reported medical history	Baseline	No
Other	Quality of Life	Series of questionnaires assessing various aspects of quality of life including physical and mental health	Baseline	No
Primary	Cognition	A series of computer-based cognitive tasks will be administered via the NIH Toolbox Cognition Battery	Baseline	No
Secondary	Physical Activity	Physical activity will be measured by a waist-worn accelerometer	Baseline	No
Secondary	Diet Quality	Diet will be assessed by completion of the online-administered 2005 Block Food Frequency Questionnaire	Baseline	No
Secondary	Body Composition (objectively measured)	Body composition will be evaluated by BOD POD assessment	Baseline	No
Secondary	Inflammatory Markers	A fasted blood sample will be collected for measurement of inflammatory markers	Baseline	No