search
Back to results

Diet Intervention, Head and Neck Cancer, Feasibility

Primary Purpose

Head and Neck Cancer

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cruciferous and Dark Leafy Green Intervention
Usual Dietary Care
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Head and Neck Cancer focused on measuring diet, nutrition, survival, recurrence, cruciferous, dark leafy greens

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Usual Dietary Care

    Cruciferous and Dark Leafy Green Intervention

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Number of patients excluded or not agreeing to participate
    Feasibility measure
    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.)
    Attrition rates
    Feasibility measure
    Adverse events with reporting according to institutional review board policy
    Questionnaire
    Participant satisfaction
    Questionnaire
    Intervention preferences

    Secondary Outcome Measures

    DNA methylation
    Serum cytokines
    Quality of life (assessed using the Functional Assessment of Cancer Therapy Head and Neck index)
    Total energy and nutrient intakes
    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)

    Full Information

    First Posted
    January 3, 2017
    Last Updated
    January 4, 2017
    Sponsor
    University of Alabama at Birmingham
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03013699
    Brief Title
    Diet Intervention, Head and Neck Cancer, Feasibility
    Official Title
    Improving Dietary Patterns in Head and Neck Cancer Survivors to Optimize Disease Outcomes and Supportive Care: A Pilot/Feasibility Intervention Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2015 (undefined)
    Primary Completion Date
    September 2016 (Actual)
    Study Completion Date
    September 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Alabama at Birmingham

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Head and Neck Cancer
    Keywords
    diet, nutrition, survival, recurrence, cruciferous, dark leafy greens

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    23 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Usual Dietary Care
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Cruciferous and Dark Leafy Green Intervention
    Arm Type
    Experimental
    Arm Description
    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 Type
    Behavioral
    Intervention Name(s)
    Cruciferous and Dark Leafy Green Intervention
    Intervention Description
    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 Type
    Behavioral
    Intervention Name(s)
    Usual Dietary Care
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Number of patients excluded or not agreeing to participate
    Description
    Feasibility measure
    Time Frame
    Baseline
    Title
    Adherence to study protocol activities (research records and diet intake self-report)
    Description
    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
    Title
    Attrition rates
    Description
    Feasibility measure
    Time Frame
    Throughout 12 week study period
    Title
    Adverse events with reporting according to institutional review board policy
    Time Frame
    Throughout 12 week study period
    Title
    Questionnaire
    Description
    Participant satisfaction
    Time Frame
    At conclusion of 12 week study period
    Title
    Questionnaire
    Description
    Intervention preferences
    Time Frame
    At conclusion of 12 week study period
    Secondary Outcome Measure Information:
    Title
    DNA methylation
    Time Frame
    At beginning and end of 12 week study period
    Title
    Serum cytokines
    Time Frame
    At beginning and end of 12 week study period
    Title
    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
    Title
    Total energy and nutrient intakes
    Time Frame
    At beginning and end of 12 week study period
    Title
    Covariates
    Description
    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)
    Time Frame
    At beginning of 12 week study period

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Laura Q. Rogers, MD
    Organizational Affiliation
    University of Alabama at Birmingham
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Diet Intervention, Head and Neck Cancer, Feasibility

    We'll reach out to this number within 24 hrs