Diet Intervention, Head and Neck Cancer, Feasibility

Not Applicable

Completed

• Conditions: Head and Neck Cancer
• Interventions: Behavioral: Usual Dietary Care; Behavioral: Cruciferous and Dark Leafy Green Intervention

• Registration Number: NCT03013699
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

This study will examine the effects of a dietary intervention in post-treatment head and neck cancer survivors on the ability to function physically, tiredness, and quality of life, as well as on changing markers in the blood that are associated with better recurrence and survival.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2017-01
• Study First Submitted: 2017-01-03
• Study First Submitted QC: 2017-01-04
• Last Update Submitted: 2017-01-04
• Study First Posted: 2017-01-06
• Last Update Posted: 2017-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

Patients will be eligible to participate if they are 1) diagnosed with Stage I - IV oral, hypopharyngeal, nasopharyngeal, oropharyngeal, or laryngeal cancer; 2) age 19+; 3) at least 6 months - 2 years post-treatment; 4) able to consume foods orally; 5) no evidence of disease; 6) English-speaking

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Exclusion Criteria

Patients will not be eligible to participate if they have 1) dementia or organic brain syndrome; 2) severe emotional distress; 3) active schizophrenia; 3) another diagnosis of cancer in the past five years (not including skin or cervical cancer in situ)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Dietary Care	Usual Dietary Care	Participants receive standard educational materials that focus on healthy eating for cancer survivors and the opportunity to briefly discuss nutrition-related concerns with the Registered Dietitian weekly.
Cruciferous and Dark Leafy Green Intervention	Cruciferous and Dark Leafy Green Intervention	Participants receive individual dietary counseling from a Registered Dietitian who will focus on increasing intake of cruciferous and green leafy vegetables while addressing any disease- and treatment-related eating difficulties experienced by the participant.

Primary Outcome Measures

Name	Time	Method
Attrition rates	Throughout 12 week study period	Feasibility measure
Adverse events with reporting according to institutional review board policy	Throughout 12 week study period
Questionnaire	At conclusion of 12 week study period	Intervention preferences
Number of patients excluded or not agreeing to participate	Baseline	Feasibility measure
Adherence to study protocol activities (research records and diet intake self-report)	Throughout 12 week study period	Feasibility measure (e.g., percent of assessments completed, percent of counseling phone calls completed, servings of cruciferous vegetables eaten, etc.)

Secondary Outcome Measures

Name	Time	Method
Quality of life (assessed using the Functional Assessment of Cancer Therapy Head and Neck index)	At beginning and end of 12 week study period
DNA methylation	At beginning and end of 12 week study period
Covariates	At beginning of 12 week study period	A questionnaire will collect a set of covariates used in the analyses (i.e., these do not represent individual outcomes; this is a group of covariates used in the data analyses). This group includes demographic characteristics (age, sex, race, ethnicity, education, income); lifestyle behaviors (tobacco use, alcohol consumption, exercise); medical history; cancer-specific clinical variables (tumor site, cancer stage, treatment modality); anthropometrics (height and weight)
Serum cytokines	At beginning and end of 12 week study period
Total energy and nutrient intakes	At beginning and end of 12 week study period