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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-07-31

Study Completion Date

2016-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Head and Neck Cancer

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Elderly Chemorads

Elderly patients with Head and Neck Cancer who are Undergoing Chemotherapy

Collect Blood and Survey Instruments

Intervention Type OTHER

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

Interventions

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Collect Blood and Survey Instruments

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

Intervention Type OTHER

Other Intervention Names

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Geriatric Assessment FACT-HN p16 Expression Health Behavior Questionnaire

Eligibility Criteria

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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.