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Fat Metabolism Following Chemotherapy in Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01890824
Recruitment Status : Terminated
First Posted : July 2, 2013
Last Update Posted : February 3, 2016
Sponsor:
Information provided by (Responsible Party):
Marielle PKJ Engelen, PhD, Texas A&M University

Study Description
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Brief Summary:
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.

Condition or disease
Breast Cancer

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 Design
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Study Type : Observational
Actual Enrollment : 5 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of Chemotherapy on Fat Metabolism and Digestion and Function in Breast Cancer Patients.
Study Start Date : August 2013
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Groups and Cohorts
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Group/Cohort
Breast Cancer Patients
Breast cancer patients to be studied before and after chemotherapy
Healthy Female Controls
Healthy female controls will be compared to breast cancer patients before and after chemotherapy and to healthy male controls
Healthy Male Controls
Healthy male controls will be compared to healthy female controls to determine gender differences


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    changes in hepatic triglyceride synthesis before and after a meal

  2. 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 ]
    changes in hepatic de novo lipogenesis before and after a meal


Secondary Outcome Measures :
  1. Adipose tissue triglyceride synthesis [ Time Frame: pre and 4 hours post meal ]
    changes in adipose tissue triglyceride synthesis before and after a meal

  2. Adipose tissue de novo lipogenesis [ Time Frame: pre and 4 hours post meal ]
    changes in adipose tissue de novo lipogenesis before and after a meal

  3. 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 ]
    changes in adipose tissue lipolysis before and after a meal. plasma enrichment of glycerol.

  4. 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 ]
    defining fat digestion and absorption after a meal. Enrichment in palmitic acid and tripalmitin fatty acids in plasma

  5. Skeletal muscle strength and endurance [ Time Frame: 1 day ]
    Difference in leg strength and fatigue

  6. Insulin response to feeding [ Time Frame: pre and up to 5 hours post meal ]
    acute changes from postabsorptive state to postprandial state

  7. Body composition [ Time Frame: 1 day ]
    body composition will be determined by dual-energy X-ray absorptiometry and by deuterated water dilution technique. Plasma deuterium enrichments will be determined.

  8. Physical activity questionnaire [ Time Frame: 1 day ]
    Outcome of physical activity assessment in breast cancer patients and healthy controls in relation to the fat metabolism


Biospecimen Retention:   Samples With DNA
Urine, adipose tissue, serum, plasma

Eligibility Criteria
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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01890824


Locations
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United States, Texas
Texas A&M University
College Station, Texas, United States, 77843
Sponsors and Collaborators
Texas A&M University
Investigators
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Principal Investigator: Marielle Engelen, Ph.D. Texas A&M University
More Information
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Responsible Party: Marielle PKJ Engelen, PhD, Ph.D., Texas A&M University
ClinicalTrials.gov Identifier: NCT01890824    
Other Study ID Numbers: 2013-0297F
First Posted: July 2, 2013    Key Record Dates
Last Update Posted: February 3, 2016
Last Verified: February 2016
Keywords provided by Marielle PKJ Engelen, PhD, Texas A&M University:
Breast Cancer
Fat metabolism
Fat digestion
physical activity
muscle function
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases