Low Antioxidant Diet in Controlling Cachexia in Patients With Oropharyngeal Cancer Receiving Chemotherapy and Radiation Therapy
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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 |
- 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 |
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| United States, North Carolina | |
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | |
| Chapel Hill, North Carolina, United States, 27599-7295 | |
| 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 May 22, 2013