Diet Intervention, Head and Neck Cancer, Feasibility

Head and Neck Cancer Clinical Trial

Official title:

Improving Dietary Patterns in Head and Neck Cancer Survivors to Optimize Disease Outcomes and Supportive Care: A Pilot/Feasibility Intervention Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03013699
• Other study ID #: X140813004
• Status: Completed
• Phase: N/A
• First received: January 3, 2017
• Last updated: January 4, 2017
• Start date: January 2015
• Est. completion date: September 2016

Study information

• Verified date: January 2017
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients excluded or not agreeing to participate	Feasibility measure	Baseline	No
Primary	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.)	Throughout 12 week study period	No
Primary	Attrition rates	Feasibility measure	Throughout 12 week study period	No
Primary	Adverse events with reporting according to institutional review board policy		Throughout 12 week study period	Yes
Primary	Questionnaire	Participant satisfaction	At conclusion of 12 week study period	No
Primary	Questionnaire	Intervention preferences	At conclusion of 12 week study period	No
Secondary	DNA methylation		At beginning and end of 12 week study period	No
Secondary	Serum cytokines		At beginning and end of 12 week study period	No
Secondary	Quality of life (assessed using the Functional Assessment of Cancer Therapy Head and Neck index)		At beginning and end of 12 week study period	No
Secondary	Total energy and nutrient intakes		At beginning and end of 12 week study period	No
Secondary	Covariates	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)	At beginning of 12 week study period	No