- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01890824
Fat Metabolism Following Chemotherapy in Breast Cancer
February 1, 2016 updated by: Marielle PKJ Engelen, PhD, Texas A&M University
The Effect of Chemotherapy on Fat Metabolism and Digestion and Function in Breast Cancer Patients.
Following chemotherapy, breast cancer patients primarily gain fat mass and lose muscle mass.
Both depletion of muscle and an increase of fat mass in breast cancer patients are related to short survival, and decreased skeletal muscle mass and function may result in fatigue and inactivity, which contributes to fat mass changes and can be responsible for chemo-toxicity and increased mortality.
The purpose of this study is to provide detailed insight in chemotherapy related changes in lipid metabolism and gut digestion and absorption of fat in breast cancer patients compared to matched healthy controls.
This will provide required information that is necessary to implement new strategies to develop optimal nutritional regimen in breast cancer patients.
The hypothesis is that chemotherapy in breast cancer is related to altered gut function and absorption and to increases in fat synthesis that lead to fat accumulation.
In addition, we will examine the effect of cancer, chemotherapy, and gender by comparing fat digestion/absorption and fat metabolism of the breast cancer before and after chemotherapy, to aged matched healthy female and male controls.
Study Overview
Status
Terminated
Conditions
Detailed Description
This research study involves 5 visits for the breast cancer subjects and 3 visits for the healthy controls.
The first visit includes the informed consent and a screening and the second and third visit for the study days before chemotherapy and the fourth and fifth visit for the study days after chemotherapy.
For the first test day, 2 hours of the subjects time will be for urine and blood sample collection, and to ingest the deuterated water.
Subjects are allowed to go home after and eat normally.
On the second study day, subjects will arrive early that morning and a DXA scan will be performed first.
For the duration of the study, subjects have to lie in the bed (except for bathroom privileges).
They can watch tv or bring and use a book/tablet.
The research nurse or study staff will be present in the human subject area to assist the subject if necessary.
Subjects are not allowed to eat or drink during the second test day, except for the test drink (meal) and water.
One IV catheter will be placed in a vein of the arm/hand for blood draws.
The hand will be placed in a hot box during blood collection.
Another IV catheter will be placed in the contra-lateral forearm for a primed and continuous infusion of 2H5-glycerol.
Over the two day time period, a total of 100-120 ml of blood will be obtained over approximately 19 samples.
Stable isotopes will be ingested on the first test day, added to the test drinks on the second test day after the second hour, and infused on the second day.
On the second test day, subjects will fill out questionnaires and perform muscle function tests.
After completion of the study, we will provide the subject with a meal.
Study Type
Observational
Enrollment (Actual)
5
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Texas
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College Station, Texas, United States, 77843
- Texas A&M University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Subjects with breast cancer will be recruited when visiting a medical or cancer clinic in and outside the surrounding area of College Station.
Cancer patients and healthy subjects will also be recruited by responding to distributed flyers in the community in the College Station area; for example in hospital/clinic waiting areas, clinic rooms and bulletin boards at Scott & White and the CSMC or any other hospital.
Other general recruitment material in relation to the nutrition research that the research group performs at Texas A&M can be placed on bulletin boards at Scott & White and the CSMC.
Description
Inclusion criteria cancer subjects:
- Diagnosed with breast cancer
- Scheduled for chemotherapy
- Ability to sign informed consent
- Age 30 years and older
- Ability to lie in supine position for 7 hours
Inclusion criteria healthy subjects:
- Healthy male & female according to the investigator's or appointed staff's judgment
- Age 30 years or older
- No diagnosis of cancer
Exclusion Criteria:
- Presence of fever within the last 3 days
- Untreated metabolic diseases including hepatic or renal disorder
- Presence of acute illness or metabolically unstable chronic illness
- Use of nutritional supplements within 5 days of first test day
- Any other condition according to the PI or nurse that would interfere with the study or safety of the patient
- Failure to give informed consent
- Possible) pregnancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Breast Cancer Patients
Breast cancer patients to be studied before and after chemotherapy
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Healthy Female Controls
Healthy female controls will be compared to breast cancer patients before and after chemotherapy and to healthy male controls
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Healthy Male Controls
Healthy male controls will be compared to healthy female controls to determine gender differences
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hepatic triglyceride synthesis
Time Frame: Pre meal ingestion and 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210, 240, 270, and 300 min post meal ingestion
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changes in hepatic triglyceride synthesis before and after a meal
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Pre meal ingestion and 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210, 240, 270, and 300 min post meal ingestion
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Hepatic de novo lipogenesis
Time Frame: Pre meal ingestion and 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210, 240, 270, and 300 min post meal ingestion
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changes in hepatic de novo lipogenesis before and after a meal
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Pre meal ingestion and 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210, 240, 270, and 300 min post meal ingestion
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adipose tissue triglyceride synthesis
Time Frame: pre and 4 hours post meal
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changes in adipose tissue triglyceride synthesis before and after a meal
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pre and 4 hours post meal
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Adipose tissue de novo lipogenesis
Time Frame: pre and 4 hours post meal
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changes in adipose tissue de novo lipogenesis before and after a meal
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pre and 4 hours post meal
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Adipose tissue lipolysis - glycerol rate of appearance
Time Frame: Pre meal ingestion and 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210, 240, 270, and 300 min post meal ingestion
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changes in adipose tissue lipolysis before and after a meal.
plasma enrichment of glycerol.
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Pre meal ingestion and 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210, 240, 270, and 300 min post meal ingestion
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Fat digestion and absorption
Time Frame: Pre meal ingestion and 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210, 240, 270, and 300 min post meal ingestion
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defining fat digestion and absorption after a meal.
Enrichment in palmitic acid and tripalmitin fatty acids in plasma
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Pre meal ingestion and 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210, 240, 270, and 300 min post meal ingestion
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Skeletal muscle strength and endurance
Time Frame: 1 day
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Difference in leg strength and fatigue
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1 day
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Insulin response to feeding
Time Frame: pre and up to 5 hours post meal
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acute changes from postabsorptive state to postprandial state
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pre and up to 5 hours post meal
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Body composition
Time Frame: 1 day
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body composition will be determined by dual-energy X-ray absorptiometry and by deuterated water dilution technique.
Plasma deuterium enrichments will be determined.
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1 day
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Physical activity questionnaire
Time Frame: 1 day
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Outcome of physical activity assessment in breast cancer patients and healthy controls in relation to the fat metabolism
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1 day
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Marielle Engelen, Ph.D., Texas A&M University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2013
Primary Completion (Actual)
October 1, 2015
Study Completion (Actual)
October 1, 2015
Study Registration Dates
First Submitted
June 27, 2013
First Submitted That Met QC Criteria
June 27, 2013
First Posted (Estimate)
July 2, 2013
Study Record Updates
Last Update Posted (Estimate)
February 3, 2016
Last Update Submitted That Met QC Criteria
February 1, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013-0297F
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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