Low Antioxidant Diet in Controlling Cachexia in Patients With Oropharyngeal Cancer Receiving Chemotherapy and Radiation Therapy

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00486304
First received: June 13, 2007
Last updated: April 16, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Cachexia
Head and Neck Cancer
Weight Changes
Other: ADD
Other: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Supportive Care
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

Resource links provided by NLM:


Further study details as provided by UNC Lineberger Comprehensive Cancer Center:

Primary Outcome Measures:
  • Number of people with adverse events [ Time Frame: 70 days ] [ Designated as safety issue: Yes ]
    Estimate the safety of the antioxidant-deficient diet (ADD) by measuring the frequency of grade 3 or 4 adverse events, per CTCAE criteria


Enrollment: 4
Study Start Date: February 2006
Study Completion Date: May 2008
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Antioxidant-deficient diet (ADD) Other: ADD
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
Placebo Comparator: Placebo Other: Placebo
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00486304

Locations
United States, North Carolina
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7295
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
Investigators
Principal Investigator: Marion Couch, MD, PhD UNC Lineberger Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00486304     History of Changes
Other Study ID Numbers: LCCC 0523, CDR0000549772
Study First Received: June 13, 2007
Last Updated: April 16, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by UNC Lineberger Comprehensive Cancer Center:
cachexia
weight changes
recurrent oropharyngeal cancer
stage I oropharyngeal cancer
stage II oropharyngeal cancer
stage III oropharyngeal cancer
stage IV oropharyngeal cancer

Additional relevant MeSH terms:
Body Weight Changes
Cachexia
Head and Neck Neoplasms
Oropharyngeal Neoplasms
Body Weight
Signs and Symptoms
Emaciation
Weight Loss
Neoplasms by Site
Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 19, 2014