Clinical trial NCT00486304: Low Antioxidant Diet in Controlling Cachexia in Patients With Oropharyngeal Cancer Receiving Chemotherapy and Radiation Therapy
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cachexia
Head and Neck Cancer
Weight Changes
Keywords: cachexia
weight changes
recurrent oropharyngeal cancer
stage I oropharyngeal cancer
stage II oropharyngeal cancer
stage III oropharyngeal cancer
stage IV oropharyngeal cancer
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-06-14
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Number of people with adverse events
timeFrame: 70 days
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
state: North Carolina
Study officials:
affiliation: UNC Lineberger Comprehensive Cancer Center
name: Marion Couch, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: