Finding Predictors of Side Effects to Chemoradiation Treatment in Elderly Patients With Head and Neck Cancer

UNC Lineberger Comprehensive Cancer Center3 enrolled

Overview

To look at what types of measures can be used to predict how an older person will tolerate chemoradiation treatment for head and neck cancer. This study uses surveys and a blood draw to look at the different measures.

Purpose: To identify baseline predictors of change in function over the course of treatment with chemoradiotherapy in patients with head and neck cancer. Participants: Patients 65 or older who have an appointment at the North Carolina Cancer Hospital (NCCH) or other participating sites, have planned chemoradiotherapy for head and neck cancer Procedures (methods): Consenting subjects will complete a Geriatric Assessment, Functional Assessment of Cancer Therapy - Head and Neck and give a blood sample for CBC and p16INK4a at the start of their chemoradiotherapy, at week four, at the end and 90 days post therapy. They will also complete a health behavior questionnaire at baseline.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Head and Neck Cancer

Interventions

Collect Blood and Survey InstrumentsOTHER

Each subject will be administered the appropriate surveys and blood draws over the course of the study.

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria * Patients will be eligible for this protocol provided they have an appointment at the North Carolina Cancer Hospital (NCCH), have planned chemoradiotherapy for head and neck cancer (any histology) and consent to complete the Geriatric Assessment. No exclusions will be made based on gender, ethnicity, performance status or race. Patient must be able to read and speak English. * Signed, IRB approved written informed consent. * Age of at least 65 years. * Enrollment in other studies, both therapeutic and observational, will not result in exclusion. Exclusion Criteria * Inability to read and speak English. * Inability to comply with study for any other reason than language

Locations (1)

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States

Outcomes

Primary Outcomes

Significant Change in Function from Baseline to Post-Treatment

To determine if there is a significant change in the Instrumental Activities of Daily Living (IADL) subscore of the Geriatric Assessment (GA) from baseline to 90 days post-treatment.

Time frame: 2 years

Secondary Outcomes

Explore Association between Baseline Measures and Decline in Living Status

To explore the association of baseline measures with time to decline in living status. (For example, completely independent to requiring home help, or requiring home help to moving to a nursing home, etc.)

Time frame: 2 years

Explore Association of Baseline Measures with Grade 3 or Higher Toxicity

To explore the association of baseline measures with the occurrence of any grade 3 or higher toxicity as a consequence of chemoradiotherapy.

Time frame: 2 years

Explore Association of Baseline p16 with Baseline GA Measures

To explore the association of baseline p16 expression with baseline subscores of the Geriatric Assessment.

Time frame: 2 years

Explore Changes in p16 Expression, GA Subscales and FACT-HN Scores Over Time.

To explore changes in p16 expression, GA subscales, and FACT-HN scores over the course of treatment

Time frame: 2 years

Explore Association between Baseline Measures and Changes in IADL Subscore

To explore the association of baseline measures with change in IADL subscore.

Time frame: 2 years

Data from ClinicalTrials.gov

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