Low Antioxidant Diet in Controlling Cachexia in Patients With Oropharyngeal Cancer Receiving Chemotherapy and Radiation Therapy

PHASE1CompletedINTERVENTIONAL
Enrollment

4

Participants

Timeline

Start Date

February 28, 2006

Primary Completion Date

February 28, 2007

Study Completion Date

May 31, 2008

Conditions
CachexiaHead and Neck CancerWeight Changes
Interventions
OTHER

ADD

The ADD has a composition of 65% carbohydrate, 20% fat, and 15% protein. The diet will be completely depleted of vitamins A, E and beta-carotene; it will have 10 mg of vitamin C (6.5% of RDA) added per person per day

OTHER

Placebo

Jevity 1.5 (1.5 cal/mL) will be used for the placebo patients in this study. This will simulate the standard of care for patients not on the ADD. Jevity 1.5 is an isotonic, fiber-fortified, high-nitrogen liquid formula providing complete, balanced nutrition for patients requiring short- or long-term tube feeding, given once per day

Trial Locations (1)

27599-7295

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

UNC Lineberger Comprehensive Cancer Center

OTHER

NCT00486304 - Low Antioxidant Diet in Controlling Cachexia in Patients With Oropharyngeal Cancer Receiving Chemotherapy and Radiation Therapy | Biotech Hunter | Biotech Hunter