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

NCT ID: NCT00486304

Last Updated: 2012-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-02-28
• Study Completion Date: 2008-05-31

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.

Conditions

Cachexia; Head and Neck Cancer; Weight Changes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Antioxidant-deficient diet (ADD)

Group Type: EXPERIMENTAL

ADD

Intervention Type: OTHER

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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

Interventions

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

Intervention Type: 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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marion Couch, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UNC Lineberger Comprehensive Cancer Center

Locations

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

Chapel Hill, North Carolina, United States

Countries

United States

Other Identifiers

CDR0000549772

Identifier Type: OTHER

Identifier Source: secondary_id

LCCC 0523

Identifier Type: -

Identifier Source: org_study_id