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Identification of Predictors of Tolerance to Chemoradiotherapy in Elderly Patients With Head and Neck Cancer


N/A
65 Years
N/A
Open (Enrolling)
Both
Head and Neck Cancer

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Trial Information

Identification of Predictors of Tolerance to Chemoradiotherapy in Elderly Patients With Head and Neck Cancer


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.

Inclusion 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

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Outcome Measure:

Significant Change in Function from Baseline to Post-Treatment

Outcome Description:

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.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Jared Weiss, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of North Carolina

Authority:

United States: Institutional Review Board

Study ID:

LCCC1208

NCT ID:

NCT01688323

Start Date:

July 2012

Completion Date:

July 2014

Related Keywords:

  • Head and Neck Cancer
  • Geriatrics
  • Oncology
  • Biological Markers
  • Survey Instruments
  • p16
  • Geriatric Oncology
  • Biological Markers of Aging
  • Symptom Assessment
  • Cancer
  • Older Persons
  • Head and Neck Cancer
  • Head and Neck Neoplasms

Name

Location
UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina