Identification of Predictors of Tolerance to Chemoradiotherapy in Elderly Patients With Head and Neck Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Head and Neck Cancer
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
- Enrollment
- 3
- Locations
- 1
- Primary Endpoint
- Significant Change in Function from Baseline to Post-Treatment
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Significant Change in Function from Baseline to Post-Treatment
Time Frame: 2 years
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.
Secondary Outcomes
- Explore Association of Baseline Measures with Grade 3 or Higher Toxicity(2 years)
- Explore Association of Baseline p16 with Baseline GA Measures(2 years)
- Explore Association between Baseline Measures and Decline in Living Status(2 years)
- Explore Changes in p16 Expression, GA Subscales and FACT-HN Scores Over Time.(2 years)
- Explore Association between Baseline Measures and Changes in IADL Subscore(2 years)