Status:
COMPLETED
Nutrition Intervention During Chemotherapy
Lead Sponsor:
Texas A&M University
Conditions:
Cancer Patients Receiving Chemotherapy or Chemoradiotherapy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Weight loss and muscle wasting commonly occurs in patients with cancer, negatively influencing their quality of life, treatment response and survival. Weight loss has been reported as a side effect of...
Detailed Description
For the cancer subjects, the study involves 1 test day prior to a chemotherapy treatment, a 10-week (± 2 weeks) nutritional intervention period at home starting the first day of the chemotherapy treat...
Eligibility Criteria
Inclusion
- Inclusion criteria cancer subjects:
- Diagnosed with cancer
- Scheduled for chemotherapy or chemoradiotherapy
- Ability to sign informed consent
- Age 18y 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 18 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, Smartfish Nutrifriend 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
Exclusion
Key Trial Info
Start Date :
April 26 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 3 2015
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT01871350
Start Date
April 26 2013
End Date
November 3 2015
Last Update
September 30 2025
Active Locations (1)
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1
Texas A&M University
College Station, Texas, United States, 77843