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

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01688323
• Other study ID #: LCCC1208
• Secondary ID: 12-0805
• Status: Completed
• Phase: N/A
• First received: September 14, 2012
• Last updated: September 11, 2017
• Start date: July 2012
• Est. completion date: May 2016

Study information

• Verified date: September 2017
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: May 2016
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Other:
• Collect Blood and Survey Instruments
Each subject will be administered the appropriate surveys and blood draws over the course of the study.

Locations

Country	Name	City	State
United States	UNC Lineberger Comprehensive Cancer Center	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Significant Change in Function from Baseline to Post-Treatment	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	Explore Association between Baseline Measures and Decline in Living Status	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
Secondary	Explore Association of Baseline Measures with Grade 3 or Higher Toxicity	To explore the association of baseline measures with the occurrence of any grade 3 or higher toxicity as a consequence of chemoradiotherapy.	2 years
Secondary	Explore Association of Baseline p16 with Baseline GA Measures	To explore the association of baseline p16 expression with baseline subscores of the Geriatric Assessment.	2 years
Secondary	Explore Changes in p16 Expression, GA Subscales and FACT-HN Scores Over Time.	To explore changes in p16 expression, GA subscales, and FACT-HN scores over the course of treatment	2 years
Secondary	Explore Association between Baseline Measures and Changes in IADL Subscore	To explore the association of baseline measures with change in IADL subscore.	2 years

External Links

•   UNC Geriatric Oncology Program