Diet Intervention, Head and Neck Cancer, Feasibility

NCT03013699 | Completed

• 1 other identifier: X140813004
• Study Type: interventional
• Target: 23
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Head and Neck Cancer

Keywords

diet; nutrition; survival; recurrence; cruciferous; dark leafy greens

Outcome Measures

Primary Outcomes (6)

• Number of patients excluded or not agreeing to participate

  Feasibility measure

  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.)

  Throughout 12 week study period

• Attrition rates

  Feasibility measure

  Throughout 12 week study period

• Adverse events with reporting according to institutional review board policy

  Throughout 12 week study period

• Questionnaire

  Participant satisfaction

  At conclusion of 12 week study period

• Questionnaire

  Intervention preferences

  At conclusion of 12 week study period

Secondary Outcomes (5)

• 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

Study Arms (2)

Usual Dietary Care

ACTIVE COMPARATOR

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.

Behavioral: Usual Dietary Care

Cruciferous and Dark Leafy Green Intervention

EXPERIMENTAL

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.

Behavioral: Cruciferous and Dark Leafy Green Intervention

Interventions

Cruciferous and Dark Leafy Green Intervention BEHAVIORAL

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.

Cruciferous and Dark Leafy Green Intervention

Usual Dietary Care BEHAVIORAL

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.

Usual Dietary Care

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

MeSH Terms

Conditions

Head and Neck Neoplasms; Recurrence

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Laura Q. Rogers, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 3, 2017
• First Posted: January 6, 2017
• Study Start: January 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: January 6, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share