Breast CancerNCT01890824
Fat Metabolism Following Chemotherapy in Breast Cancer
An observational study of Breast Cancer, run by Texas A&M University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Oct 2015
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
- Healthy male \& female according to the investigator's or appointed staff's judgment
- Age 30 years or older
- No diagnosis of cancer
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Fat metabolism, Fat digestion, physical activity, muscle function
- Medical subject headings
- Breast Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hepatic triglyceride synthesis
changes in hepatic triglyceride synthesis before and after a meal
Measured: Pre meal ingestion and 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210, 240, 270, and 300 min post meal ingestion
Hepatic de novo lipogenesis
changes in hepatic de novo lipogenesis before and after a meal
Measured: Pre meal ingestion and 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210, 240, 270, and 300 min post meal ingestion
Secondary outcomes (8)
Adipose tissue triglyceride synthesis
changes in adipose tissue triglyceride synthesis before and after a meal
Measured: pre and 4 hours post meal
Adipose tissue de novo lipogenesis
changes in adipose tissue de novo lipogenesis before and after a meal
Measured: pre and 4 hours post meal
Adipose tissue lipolysis - glycerol rate of appearance
changes in adipose tissue lipolysis before and after a meal. plasma enrichment of glycerol.
Measured: Pre meal ingestion and 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210, 240, 270, and 300 min post meal ingestion
Fat digestion and absorption
defining fat digestion and absorption after a meal. Enrichment in palmitic acid and tripalmitin fatty acids in plasma
Measured: Pre meal ingestion and 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210, 240, 270, and 300 min post meal ingestion
Skeletal muscle strength and endurance
Difference in leg strength and fatigue
Measured: 1 day
Insulin response to feeding
acute changes from postabsorptive state to postprandial state
Measured: pre and up to 5 hours post meal
Body composition
body composition will be determined by dual-energy X-ray absorptiometry and by deuterated water dilution technique. Plasma deuterium enrichments will be determined.
Measured: 1 day
Physical activity questionnaire
Outcome of physical activity assessment in breast cancer patients and healthy controls in relation to the fat metabolism
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2013 (estimated)
- Study startAug 2013
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas A&M University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marielle PKJ Engelen, PhD, Texas A&M University
- Investigators
- Marielle Engelen, Ph.D., Principal investigator, Texas A&M University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01890824
- Sponsor's protocol ID
- 2013-0297F
- Status last verified
- Feb 2016
- First submitted
- 27 Jun 2013
- Last updated
- 3 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Huttl VN, Deutz N, Wierzchowska-McNew RA, Ruebush LE, Engelen M. Whole-body and intracellular arginine metabolism in hypertension: role of disease severity and sex. Am J Hypertens. 2026 May 18:hpag047. doi: 10.1093/ajh/hpag047. Online ahead of print.
PubMed 42149813
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Chemotherapy on Fat Metabolism and Digestion and Function in Breast Cancer Patients.
- ClinicalTrials.gov ID
- NCT01890824
- Acronym / sponsor ID
- 2013-0297F
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Fat metabolism, Fat digestion, physical activity, muscle function
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Texas A&M UniversityUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 2 Jul 2013 (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.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
8 secondary outcomes
Adipose tissue triglyceride synthesis
Time frame: pre and 4 hours post meal
Adipose tissue de novo lipogenesis
Time frame: pre and 4 hours post meal
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
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
Skeletal muscle strength and endurance
Time frame: 1 day
Insulin response to feeding
Time frame: pre and up to 5 hours post meal
Body composition
Time frame: 1 day
Physical activity questionnaire
Time frame: 1 day
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2016.
- Derived from this study: PubMed 42149813Huttl VN, Deutz N, Wierzchowska-McNew RA, Ruebush LE, Engelen M. Whole-body and intracellular arginine metabolism in hypertension: role of disease severity and sex. Am J Hypertens. 2026 May 18:hpag047. doi: 10.1093/ajh/hpag047. Online ahead of print.
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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.
Marielle Engelen, Ph.D. principal investigator
Texas A&M University
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, run by Texas A&M University 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 7 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: stopped early, as of the sponsor's last update on 3 Feb 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 was stopped early. Results are not available in the source record.
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?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01890824, which also lists 1 linked publication.
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 3 Feb 2016.