Fat Metabolism Following Chemotherapy in Breast Cancer

Breast Cancer Clinical Trial

Official title:

The Effect of Chemotherapy on Fat Metabolism and Digestion and Function in Breast Cancer Patients.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01890824
• Other study ID #: 2013-0297F
• Status: Terminated
• Phase: N/A
• First received: June 27, 2013
• Last updated: February 1, 2016
• Start date: August 2013
• Est. completion date: October 2015

Study information

• Verified date: February 2016
• Source: Texas A&M University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
United States	Texas A&M University	College Station	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas A&M University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hepatic triglyceride synthesis	changes in hepatic triglyceride synthesis before and after a meal	Pre meal ingestion and 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210, 240, 270, and 300 min post meal ingestion	No
Primary	Hepatic de novo lipogenesis	changes in hepatic de novo lipogenesis before and after a meal	Pre meal ingestion and 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210, 240, 270, and 300 min post meal ingestion	No
Secondary	Adipose tissue triglyceride synthesis	changes in adipose tissue triglyceride synthesis before and after a meal	pre and 4 hours post meal	No
Secondary	Adipose tissue de novo lipogenesis	changes in adipose tissue de novo lipogenesis before and after a meal	pre and 4 hours post meal	No
Secondary	Adipose tissue lipolysis - glycerol rate of appearance	changes in adipose tissue lipolysis before and after a meal. plasma enrichment of glycerol.	Pre meal ingestion and 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210, 240, 270, and 300 min post meal ingestion	No
Secondary	Fat digestion and absorption	defining fat digestion and absorption after a meal. Enrichment in palmitic acid and tripalmitin fatty acids in plasma	Pre meal ingestion and 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210, 240, 270, and 300 min post meal ingestion	No
Secondary	Skeletal muscle strength and endurance	Difference in leg strength and fatigue	1 day	No
Secondary	Insulin response to feeding	acute changes from postabsorptive state to postprandial state	pre and up to 5 hours post meal	No
Secondary	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.	1 day	No
Secondary	Physical activity questionnaire	Outcome of physical activity assessment in breast cancer patients and healthy controls in relation to the fat metabolism	1 day	No