Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2025-12-24 @ 9:11 PM
NCT ID:
NCT00486304
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00486304
Study Brief:
Protocol Section:
NCT00486304