Skip to main content
OpenTrials
Completed

NCT Number: NCT01688323

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27514, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Collect Blood and Survey Instruments

Other

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

Other names: Geriatric Assessment, FACT-HN, p16 Expression, Health Behavior Questionnaire

Primary outcomes

  1. 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

  1. Explore Association between Baseline Measures and Decline in Living Status

    Time frame: 2 years

    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.)

  2. Explore Association of Baseline Measures with Grade 3 or Higher Toxicity

    Time frame: 2 years

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

  3. Explore Association of Baseline p16 with Baseline GA Measures

    Time frame: 2 years

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

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

    Time frame: 2 years

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

  5. Explore Association between Baseline Measures and Changes in IADL Subscore

    Time frame: 2 years

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

Sponsors and collaborators

Lead sponsor

UNC Lineberger Comprehensive Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2016
First posted
Sep 19, 2012
Registry last updated
Sep 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.