Head and Neck Cancer
Conditions
Keywords
diet, nutrition, survival, recurrence, cruciferous, dark leafy greens
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.
Interventions
BEHAVIORALCruciferous 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.
BEHAVIORALUsual 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.
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Questionnaire | At conclusion of 12 week study period | Participant satisfaction |
| 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.) |
| Attrition rates | Throughout 12 week study period | Feasibility measure |
| Adverse events with reporting according to institutional review board policy | Throughout 12 week study period | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| DNA methylation | At beginning and end of 12 week study period | — |
| Serum cytokines | 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 | — |
| Total energy and nutrient intakes | 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) |
Outcome results
None listed