Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2025-12-24 @ 9:11 PM
NCT ID:
NCT00486304
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.
Study:
NCT00486304
Study Brief:
Protocol Section:
NCT00486304