Fat Metabolism Following Chemotherapy in Breast Cancer

NCT01890824 | Terminated

• 1 other identifier: 2013-0297F
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Breast Cancer; Fat metabolism; Fat digestion; physical activity; muscle function

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (8)

• Adipose tissue triglyceride synthesis

  pre and 4 hours post meal

• Adipose tissue de novo lipogenesis

  pre and 4 hours post meal

• Adipose tissue lipolysis - glycerol rate of appearance

  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

  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

  1 day

Study Arms (3)

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

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Texas A&M University: lead

Study Sites (1)

Texas A&M University

College Station, Texas, 77843, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Urine, adipose tissue, serum, plasma

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Study Officials

• Marielle Engelen, Ph.D.

  Texas A&M University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D.

Study Record Dates

• First Submitted: June 27, 2013
• First Posted: July 2, 2013
• Study Start: August 1, 2013
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: February 3, 2016

Record last verified: 2016-02

Locations

US (1)