Breast CancerNCT02591316
Nutrition, Physical Activity, and Cognition in Breast Cancer Survivors
An observational study of Breast Cancer and Cognitive Impairment, run by Texas State University, San Marcos at 1 site in United States.
Trial summary
The purpose of this study is to examine the relationship between nutrition, physical activity and brain function in breast cancer survivors. Read more about this study
- Who is it for?
- Ages 30 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Cognitive Impairment, Cognition
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to May 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Female breast cancer survivors and women who have never had a previous cancer diagnosis
Who may be able to join
- 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 ®).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lifestyle Factors, Inflammation, and Cognition in Breast Cancer Survivors
The purpose of this study is to examine the relationship between nutrition, physical activity and brain function in breast cancer survivors.
Read the detailed 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.
- Conditions
- Breast Cancer, Cognitive Impairment, Cognition
- Being tested
- no intervention
- Keywords
- nutrition, physical activity, breast cancer survivor, cognition
- Medical subject headings
- Breast Neoplasms, Cognitive Dysfunction, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer survivor | Inclusion criteria: Female breast cancer survivors (30-70yrs of age) that have completed primary treatment (chemotherapy, radiation therapy or both) within past 60 months Receives: Other: no intervention | |
| Control | Females (30-70yrs of age) with no previous cancer diagnosis. Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognition
A series of computer-based cognitive tasks will be administered via the NIH Toolbox Cognition Battery
Measured: Baseline
Secondary outcomes (4)
Physical Activity
Physical activity will be measured by a waist-worn accelerometer
Measured: Baseline
Diet Quality
Diet will be assessed by completion of the online-administered 2005 Block Food Frequency Questionnaire
Measured: Baseline
Body Composition (objectively measured)
Body composition will be evaluated by BOD POD assessment
Measured: Baseline
Inflammatory Markers
A fasted blood sample will be collected for measurement of inflammatory markers
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2015 (estimated)
- Study startFeb 2015
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas State University, San Marcos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Krystle Zuniga, Texas State University, San Marcos
- Investigators
- Krystle E Zuniga, PhD, RD, Principal investigator, Texas State University, San Marcos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02591316
- Sponsor's protocol ID
- 2014T34
- Status last verified
- Jul 2016
- First submitted
- 27 Oct 2015
- Last updated
- 19 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lifestyle Factors, Inflammation, and Cognition in Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT02591316
- Acronym / sponsor ID
- 2014T34
- Conditions
- Breast Cancer, Cognitive Impairment, Cognition
- Keywords
- nutrition, physical activity, breast cancer survivor, cognition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Texas State University, San MarcosUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 29 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the relationship between nutrition, physical activity and brain function in breast cancer survivors.
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breast cancer survivor | – | Other: no interventionInclusion criteria: Female breast cancer survivors (30-70yrs of age) that have completed primary treatment (chemotherapy, radiation therapy or both) within past 60 months |
| Control | – | Other: no interventionFemales (30-70yrs of age) with no previous cancer diagnosis. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Female breast cancer survivors and women who have never had a previous cancer diagnosis
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no intervention | Other | Breast cancer survivor, Control |
Primary outcome
Cognition
Time frame: Baseline
A series of computer-based cognitive tasks will be administered via the NIH Toolbox Cognition Battery
4 secondary outcomes
Physical Activity
Time frame: Baseline
Diet Quality
Time frame: Baseline
Body Composition (objectively measured)
Time frame: Baseline
Inflammatory Markers
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Krystle E Zuniga, PhD, RD principal investigator
Texas State University, San Marcos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Cognitive Impairment, run by Texas State University, San Marcos at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognition (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2016.