Low Antioxidant Diet in Controlling Cachexia in Patients With Oropharyngeal Cancer Receiving Chemotherapy and Radiation Therapy
Primary Purpose
Cachexia, Head and Neck Cancer, Weight Changes
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ADD
Placebo
Sponsored by
About this trial
This is an interventional supportive care trial for Cachexia focused on measuring cachexia, weight changes, recurrent oropharyngeal cancer, stage I oropharyngeal cancer, stage II oropharyngeal cancer, stage III oropharyngeal cancer, stage IV oropharyngeal cancer
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
Sites / Locations
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Antioxidant-deficient diet (ADD)
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Number of people with adverse events
Estimate the safety of the antioxidant-deficient diet (ADD) by measuring the frequency of grade 3 or 4 adverse events, per CTCAE criteria
Secondary Outcome Measures
Full Information
NCT ID
NCT00486304
First Posted
June 13, 2007
Last Updated
April 16, 2012
Sponsor
UNC Lineberger Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00486304
Brief Title
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
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
May 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNC Lineberger Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Antioxidant-deficient diet (ADD)
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
ADD
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of people with adverse events
Description
Estimate the safety of the antioxidant-deficient diet (ADD) by measuring the frequency of grade 3 or 4 adverse events, per CTCAE criteria
Time Frame
70 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marion Couch, MD, PhD
Organizational Affiliation
UNC Lineberger Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7295
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Low Antioxidant Diet in Controlling Cachexia in Patients With Oropharyngeal Cancer Receiving Chemotherapy and Radiation Therapy
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