Phase I Randomized, Double-blind, Placebo-controlled Trial of the Effect of Temporary Dietary Antioxidant Depletion on Tumor Growth and Cachexia in Head and Neck Cancer Patients Receiving Chemoradiation Therapy
- Determine the safety of the antioxidant-deficient diet (ADD) in controlling cachexia in
patients with oropharyngeal cancer receiving chemoradiotherapy.
- Determine the safety of the ADD as measured by quality of life, peripheral DNA damage,
and change in body weight.
- Determine the effectiveness of the ADD on tumor growth and surrogate markers of tumor
- Determine whether the ADD is effective in improving the tumor cachexia syndrome in
- Determine whether there is a serum metabolomic signature for the ADD.
OUTLINE: This a prospective, randomized, double-blind, placebo-controlled study. Patients
are randomized to 1 of 2 treatment arms.
- Arm I: Patients consume a standard diet 3 times a day for 8 weeks.
- Arm II: Patients consume an antioxidant-deficient diet (ADD) 3 times a day for 8 weeks.
Patients receive replacement vitamins in week 9.
All patients receive planned chemoradiotherapy in weeks 3-8.
Quality of life, body composition (by dual-energy x-ray absorptiometry), weight, and resting
energy expenditure (by indirect calorimetry) are assessed at baseline and at week 8.
Blood samples are collected at baseline and at 8 weeks. Samples are evaluated for cytokine
levels; evidence of DNA damage from peripheral blood lymphocytes; and serum signature
characteristic to ADD by multinuclear MRI spectroscopy. Patients undergo a tumor biopsy in
week 4 for research studies. Samples are collected and evaluated for generation of reactive
oxygen species by using antibodies against oxidatively modified DNA and lipids; apoptosis
using TdT-mediated dUTP nick-end labeling assay and classical morphological criteria; and
levels of the tumor toxohormones lipid mobilizing factor and proteolysis inducing factor by
real time-PCR, northern blotting, and western blotting methods.
After completion of study therapy, patients are followed once during weeks 9-12.
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care
Number of people with adverse events
Estimate the safety of the antioxidant-deficient diet (ADD) by measuring the frequency of grade 3 or 4 adverse events, per CTCAE criteria
Marion Couch, MD, PhD
UNC Lineberger Comprehensive Cancer Center
United States: Institutional Review Board
|Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill||Chapel Hill, North Carolina 27599-7570|