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

Completed

• Conditions: Head and Neck Cancer
• Interventions: Other: Collect Blood and Survey Instruments

• Registration Number: NCT01688323
• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

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.

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-09-14
• Study First Submitted QC: 2012-09-14
• Study First Posted: 2012-09-19
• Primary Completion: 2014-07
• Study Completion: 2016-05
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-11
• Last Update Posted: 2017-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Elderly Chemorads	Collect Blood and Survey Instruments	Elderly patients with Head and Neck Cancer who are Undergoing Chemotherapy

Primary Outcome Measures

Name	Time	Method
Significant Change in Function from Baseline to Post-Treatment	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 Outcome Measures

Name	Time	Method
Explore Association of Baseline Measures with Grade 3 or Higher Toxicity	2 years	To explore the association of baseline measures with the occurrence of any grade 3 or higher toxicity as a consequence of chemoradiotherapy.
Explore Association of Baseline p16 with Baseline GA Measures	2 years	To explore the association of baseline p16 expression with baseline subscores of the Geriatric Assessment.
Explore Association between Baseline Measures and Decline in Living Status	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.)
Explore Changes in p16 Expression, GA Subscales and FACT-HN Scores Over Time.	2 years	To explore changes in p16 expression, GA subscales, and FACT-HN scores over the course of treatment
Explore Association between Baseline Measures and Changes in IADL Subscore	2 years	To explore the association of baseline measures with change in IADL subscore.

Trial Locations

Locations (1)

UNC Lineberger Comprehensive Cancer Center; 🇺🇸 Chapel Hill, North Carolina, United States