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

NCT00486304 | Completed Phase 1 DMC

• 2 other identifiers: LCCC 0523CDR0000549772
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

  70 days

Study Arms (2)

Antioxidant-deficient diet (ADD)

EXPERIMENTAL

Other: ADD

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

ADD 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

Antioxidant-deficient diet (ADD)

Placebo 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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

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

Chapel Hill, North Carolina, 27599-7295, United States

Location

MeSH Terms

Conditions

Cachexia; Head and Neck Neoplasms; Body Weight Changes; Oropharyngeal Neoplasms

Condition Hierarchy (Ancestors)

Weight Loss; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness; Neoplasms by Site; Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Study Officials

• Marion Couch, MD, PhD

  UNC Lineberger Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2007
• First Posted: June 14, 2007
• Study Start: February 1, 2006
• Primary Completion: February 1, 2007
• Study Completion: May 1, 2008
• Last Updated: April 18, 2012

Record last verified: 2012-04

Locations

US (1)