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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

Phase 1
18 Years
Not Enrolling
Cachexia, Head and Neck Cancer, Weight Changes

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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



- Determine the safety of the antioxidant-deficient diet (ADD) in controlling cachexia in
patients with oropharyngeal cancer receiving chemoradiotherapy.


- 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

- 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


- Biopsy-proven carcinoma of the oropharynx (regardless of primary diagnosis or

- No active treatment for disease within the past 4 weeks


- 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


- See Disease Characteristics

- No concurrent parenteral nutrition

Type of Study:


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:


Principal Investigator

Marion Couch, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UNC Lineberger Comprehensive Cancer Center


United States: Institutional Review Board

Study ID:

LCCC 0523



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



Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Chapel Hill, North Carolina  27599-7570