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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

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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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