Diet Intervention, Head and Neck Cancer, Feasibility

University of Alabama at Birmingham23 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Head and Neck Cancer

Interventions

Cruciferous and Dark Leafy Green InterventionBEHAVIORAL

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.

Usual Dietary CareBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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 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)

Outcomes

Primary Outcomes

Number of patients excluded or not agreeing to participate

Feasibility measure

Time frame: Baseline

Adherence to study protocol activities (research records and diet intake self-report)

Feasibility measure (e.g., percent of assessments completed, percent of counseling phone calls completed, servings of cruciferous vegetables eaten, etc.)

Time frame: Throughout 12 week study period

Attrition rates

Feasibility measure

Time frame: Throughout 12 week study period

Adverse events with reporting according to institutional review board policy

Time frame: Throughout 12 week study period

Questionnaire

Participant satisfaction

Time frame: At conclusion of 12 week study period

Questionnaire

Intervention preferences

Time frame: At conclusion of 12 week study period

Secondary Outcomes

DNA methylation

Time frame: At beginning and end of 12 week study period

Serum cytokines

Time frame: At beginning and end of 12 week study period

Quality of life (assessed using the Functional Assessment of Cancer Therapy Head and Neck index)

Time frame: At beginning and end of 12 week study period

Data from ClinicalTrials.gov

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