Improving Dietary Patterns in Head and Neck Cancer Survivors to Optimize Disease Outcomes and Supportive Care: A Pilot/Feasibility Intervention Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 23
- Primary Endpoint
- Adverse events with reporting according to institutional review board policy
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
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.
Intervention: Usual Dietary Care (Behavioral)
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.
Intervention: Cruciferous and Dark Leafy Green Intervention (Behavioral)
Outcomes
Primary Outcomes
Adverse events with reporting according to institutional review board policy
Time Frame: Throughout 12 week study period
Questionnaire
Time Frame: At conclusion of 12 week study period
Participant satisfaction
Attrition rates
Time Frame: Throughout 12 week study period
Feasibility measure
Number of patients excluded or not agreeing to participate
Time Frame: Baseline
Feasibility measure
Adherence to study protocol activities (research records and diet intake self-report)
Time Frame: 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 Outcomes
- 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)
- 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)
Investigators
Laura Q. Rogers, MD, MPH
Principal Investigator
University of Alabama at Birmingham