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
18 Years
N/A
Both
Cachexia, Head and Neck Cancer, Weight Changes
Trial Information
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
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care
Outcome Measure:
Number of people with adverse events
Outcome Description:
Estimate the safety of the antioxidant-deficient diet (ADD) by measuring the frequency of grade 3 or 4 adverse events, per CTCAE criteria
Outcome Time Frame:
70 days
Safety Issue:
Yes
Principal Investigator
Marion Couch, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
UNC Lineberger Comprehensive Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
LCCC 0523
NCT ID:
NCT00486304
Start Date:
February 2006
Completion Date:
May 2008
Related Keywords:
- Cachexia
- Head and Neck Cancer
- Weight Changes
- cachexia
- weight changes
- recurrent oropharyngeal cancer
- stage I oropharyngeal cancer
- stage II oropharyngeal cancer
- stage III oropharyngeal cancer
- stage IV oropharyngeal cancer
- Body Weight Changes
- Cachexia
- Head and Neck Neoplasms
- Oropharyngeal Neoplasms
Name | Location |
|---|---|
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill, North Carolina 27599-7570 |
