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

September 11, 2017 updated by: UNC Lineberger Comprehensive Cancer Center

Identification of Predictors of Tolerance to Chemoradiotherapy 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • UNC Lineberger Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Elderly (65 and older) patients with Head and Neck Cancer

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Elderly Chemorads
Elderly patients with Head and Neck Cancer who are Undergoing Chemotherapy
Other: Collect Blood and Survey Instruments
Each subject will be administered the appropriate surveys and blood draws over the course of the study.
Other Names:
  • Geriatric Assessment
  • Health Behavior Questionnaire
  • FACT-HN
  • p16 Expression

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 years
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.
2 years
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.
2 years
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
2 years
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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UNC Lineberger Comprehensive Cancer Center

Investigators

  • Principal Investigator: Jared Weiss, MD, University of North Carolina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2012

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

September 14, 2012

First Submitted That Met QC Criteria

September 14, 2012

First Posted (Estimate)

September 19, 2012

Study Record Updates

Last Update Posted (Actual)

September 12, 2017

Last Update Submitted That Met QC Criteria

September 11, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LCCC1208
  • 12-0805 (Other Identifier: UNC IRB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Head and Neck Cancer

Clinical Trials on Collect Blood and Survey Instruments

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Trinidad & Tobago

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe