Diet Intervention, Head and Neck Cancer, Feasibility

The University of Alabama at Birmingham

Status: Completed

Conditions: Head and Neck Cancer

Treatments: Behavioral: Usual Dietary Care; Behavioral: Cruciferous and Dark Leafy Green Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03013699

X140813004

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: All

Ages: 19+ years old

Volunteers: No 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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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23 participants in 2 patient groups

Usual Dietary Care

Active Comparator group

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.

Treatment:

Behavioral: Usual Dietary Care

Cruciferous and Dark Leafy Green Intervention

Experimental group

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.

Treatment:

Behavioral: Cruciferous and Dark Leafy Green Intervention