Cachexia, Head and Neck Cancer, Weight Changes
Conditions
Keywords
cachexia, weight changes, recurrent oropharyngeal cancer, stage I oropharyngeal cancer, stage II oropharyngeal cancer, stage III oropharyngeal cancer, stage IV oropharyngeal cancer
Brief 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.
Detailed description
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.
Interventions
OTHERADD
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
OTHERPlacebo
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
Sponsors
National Cancer Institute (NCI)
UNC Lineberger Comprehensive Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of people with adverse events | 70 days | Estimate the safety of the antioxidant-deficient diet (ADD) by measuring the frequency of grade 3 or 4 adverse events, per CTCAE criteria |
Countries
United States
Outcome results
None listed