Effects of Chemotherapy and Nutritional Intervention on Gut Function and Metabolism in Cancer
25 Years
N/A
Both
Cancer Patients Receiving Platinum-based Chemotherapy
Trial Information
Effects of Chemotherapy and Nutritional Intervention on Gut Function and Metabolism in Cancer
For the cancer subjects, the study involves 1 test day (approx. 8 hours) before
chemotherapy, an approximately 12-week intervention at home starting the first day of
chemotherapy, and one test day after this intervention. A common treatment plan for the
platinum-based chemo is four doses with 3 week intervals and a clinical evaluation after
these 12 weeks. Cancer subjects will be randomly assigned to receiver either fish oil or a
placebo and protein or a placebo and will take these supplements daily throughout those 12
weeks.
For the healthy subjects, the study will involve one test day (approx. 8 hours)
On these test days, the response to a protein meal will be examined and subjects will
receive a mixture of amino acids which are a little bit heavier than normal, called stable
isotopes. Subjects will also ingest a sugar drink to assess gut permeability. In total,
approximate 120 ml of blood will be drawn on each test day to assess outcome measures. The
investigators' will also collect urine over these 8 hours, and cancer subjects are asked to
collect a fecal sample the day before the test day.
Inclusion Criteria
Inclusion criteria cancer subjects:
- Recently diagnosed with cancer
- Will receive platinum-based chemotherapy
- Ability to sign informed consent
- Age 25y and older
- Ability to lie in supine position for 7 hours
Inclusion criteria healthy subjects:
- Healthy male or female according to the investigator's or appointed staff's judgment
- Age 45 years or older
- No diagnosis of cancer
Exclusion Criteria
- Presence of fever within the last 3 days
- BMI > 38 kg/m2 (healthy controls only)
- Untreated metabolic diseases including hepatic or renal disorder
- Presence of acute illness or metabolically unstable chronic illness
- Use of protein or amino acid containing nutritional supplements within 5 days of
first test day
- Known hypersensitivity to fish and/or shellfish, Swanson EFAs Super EPA Fish oil or
any of its ingredients, Swanson EFAs Certified Organic Extra Virgin Olive oil or
any of its ingredients (Cancer subjects only)
- Use of supplements containing EPA+DHA 3 months prior to the 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
Outcome Measure:
Net whole-body protein synthesis
Outcome Description:
The acute change in whole-body protein synthesis rate before and after intake of meal is determined on the first test day for the healthy control group and the cancer group. Secondly, the cancer patients in all 3 intervention arms are also measured after 12 weeks of intervention to examine the effects of fish oil and protein supplementation during chemotherapy on this outcome measure.
Outcome Time Frame:
Acutely before and after 4 hours of feeding and the change after 12 weeks of supplementation
Safety Issue:
No
Principal Investigator
Marielle PKJ Engelen, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Texas A&M Univeristy
Authority:
United States: Institutional Review Board
Study ID:
2012-0504
NCT ID:
NCT01871350
Start Date:
April 2013
Completion Date:
April 2016
Related Keywords:
- Cancer Patients Receiving Platinum-based Chemotherapy
- Cancer
- Chemotherapy
- Chemo related toxicity
- Protein digestion
- Fat digestion
- Gut function
- Glucose absorption
- Muscle function
Name | Location |
|---|---|
| Texas A&M University | College Station, Texas 77843 |
