low antioxidant diet in controlling cachexia in patients with oropharyngeal cancer receiving chemotherapy and radiation therapy

Conditions: Cachexia; Head and Neck Cancer; Weight Changes

Summary: rationale: eating a diet that is low in antioxidants may control cachexia in patients with oropharyngeal cancer. purpose: this randomized phase i trial is studying the side effects of a low antioxidant diet in controlling cachexia in patients with oropharyngeal cancer receiving chemotherapy and radiation therapy.

objectives: primary * determine the safety of the antioxidant-deficient diet (add) in controlling cachexia in patients with oropharyngeal cancer receiving chemoradiotherapy. secondary * 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 growth. * determine whether the add is effective in improving the tumor cachexia syndrome in these patients. * 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.

Eligibility criteria:
disease characteristics: * biopsy-proven carcinoma of the oropharynx (regardless of primary diagnosis or recurrence) * no active treatment for disease within the past 4 weeks patient characteristics: * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * feeding tubes allowed * prior malignancies allowed provided all of the following criteria are met: * patient has undergone potentially curative therapy for all prior malignancies * there has been no evidence of any prior malignancies within the past 5 years (except for successfully treated cervical or non-melanoma skin cancer with no evidence of recurrences) * patient is deemed by their treating physician to be at low risk for recurrence from prior malignancies * must be able to speak english * must have adequate home refrigeration * no intractable vomiting * no ascites or clinical/ultrasound evidence of fluid retention * no uncontrolled hypertension * no severe congestive heart failure * no pneumonia * no severe infections * no known hiv positivity * no coexisting medical condition that would preclude study compliance * no decisionally-impaired individuals * no history of abetalipoproteinemia (bassen-kornzweig syndrome) * no history of spinocerebellar ataxia * no history of chronic cholestatic hepatobiliary disease * no history of diagnosed vitamin e deficiency * no history of protein-energy malnutrition (marasmus or kwashiorkor) * no history of disorders related to malabsorption (e.g., celiac disease, sprue, cystic fibrosis, duodenal bypass, congenital partial obstruction of the jejunum, obstruction of the bile ducts, giardiasis, or cirrhosis) * no history of achlorhydria prior concurrent therapy: * see disease characteristics * no concurrent parenteral nutrition

Keywords: cachexia weight changes recurrent oropharyngeal cancer stage i oropharyngeal cancer stage ii oropharyngeal cancer stage iii oropharyngeal cancer stage iv oropharyngeal cancer