Clinical trial NCT01688323: Finding Predictors of Side Effects to Chemoradiation Treatment in Elderly Patients With Head and Neck Cancer
Official title: Identification of Predictors of Tolerance to Chemoradiotherapy in Elderly Patients With Head and Neck Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head and Neck Cancer
Keywords: Geriatrics
Oncology
Biological Markers
Survey Instruments
p16
Geriatric Oncology
Biological Markers of Aging
Symptom Assessment
Cancer
Older Persons
Head and Neck Cancer
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2012-09-19
Enrollment: 3
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elderly (65 and older) patients with Head and Neck Cancer

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.

Eligibility criteria: 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

Primary outcomes:
measure: Significant Change in Function from Baseline to Post-Treatment
timeFrame: 2 years
Secondary outcomes:
measure: Explore Association between Baseline Measures and Decline in Living Status
timeFrame: 2 years
measure: Explore Association of Baseline Measures with Grade 3 or Higher Toxicity
timeFrame: 2 years
measure: Explore Association of Baseline p16 with Baseline GA Measures
timeFrame: 2 years
measure: Explore Changes in p16 Expression, GA Subscales and FACT-HN Scores Over Time.
timeFrame: 2 years
measure: Explore Association between Baseline Measures and Changes in IADL Subscore
timeFrame: 2 years
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Lineberger Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: University of North Carolina
name: Jared Weiss, MD
role: PRINCIPAL_INVESTIGATOR
References: