Head and Neck CancerNCT01688323
Finding Predictors of Side Effects to Chemoradiation Treatment in Elderly Patients With Head and Neck Cancer
An observational study of Head and Neck Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Collect Blood and Survey Instruments
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to May 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Elderly (65 and older) patients with Head and Neck Cancer
Who may be able to join
- 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.
Who cannot join
- Inability to read and speak English.
- Inability to comply with study for any other reason than language
Trial locations and contacts
1 site in 1 country.
United States1 site
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27514
About this study
Official title: 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.
Read the 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.
- Conditions
- Head and Neck Cancer
- Being tested
- Collect Blood and Survey Instruments
- Keywords
- Geriatrics, Oncology, Biological Markers, Survey Instruments, p16, Geriatric Oncology, Biological Markers of Aging, Symptom Assessment, Cancer, Older Persons, Head and Neck Cancer
- Medical subject headings
- Head and Neck Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collect Blood and Survey InstrumentsOther
Also called Geriatric Assessment, FACT-HN, p16 Expression, Health Behavior Questionnaire
Each subject will be administered the appropriate surveys and blood draws over the course of the study.
| Study group | Role | What they receive |
|---|---|---|
| Elderly Chemorads | Elderly patients with Head and Neck Cancer who are Undergoing Chemotherapy Receives: Other: Collect Blood and Survey Instruments |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (5)
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.)
Measured: 2 years
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.
Measured: 2 years
Explore Association of Baseline p16 with Baseline GA Measures
To explore the association of baseline p16 expression with baseline subscores of the Geriatric Assessment.
Measured: 2 years
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
Measured: 2 years
Explore Association between Baseline Measures and Changes in IADL Subscore
To explore the association of baseline measures with change in IADL subscore.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2012 (estimated)
- Study startJul 2012
- Primary completionJul 2014
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jared Weiss, MD, Principal investigator, University of North Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01688323
- Sponsor's protocol ID
- LCCC1208
- Other IDs
- 12-0805
- Status last verified
- Sep 2017
- First submitted
- 14 Sep 2012
- Last updated
- 12 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Predictors of Tolerance to Chemoradiotherapy in Elderly Patients With Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT01688323
- Acronym / sponsor ID
- LCCC1208
- Conditions
- Head and Neck Cancer
- Keywords
- Geriatrics, Oncology, Biological Markers, Survey Instruments, p16, Geriatric Oncology, Biological Markers of Aging, Symptom Assessment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Jul 2012 (actual)
- Primary completion
- Jul 2014 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 19 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elderly Chemorads | – | Other: Collect Blood and Survey InstrumentsElderly patients with Head and Neck Cancer who are Undergoing Chemotherapy |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Elderly (65 and older) patients with Head and Neck Cancer
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Inability to read and speak English.
- Inability to comply with study for any other reason than language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collect Blood and Survey InstrumentsAlso: Geriatric Assessment, FACT-HN, p16 Expression, Health Behavior QuestionnaireEach subject will be administered the appropriate surveys and blood draws over the course of the study. | Other | Elderly Chemorads |
Primary outcome
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.
5 secondary outcomes
Explore Association between Baseline Measures and Decline in Living Status
Time frame: 2 years
Explore Association of Baseline Measures with Grade 3 or Higher Toxicity
Time frame: 2 years
Explore Association of Baseline p16 with Baseline GA Measures
Time frame: 2 years
Explore Changes in p16 Expression, GA Subscales and FACT-HN Scores Over Time.
Time frame: 2 years
Explore Association between Baseline Measures and Changes in IADL Subscore
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2017.
- UNC Geriatric Oncology ProgramLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jared Weiss, MD principal investigator
University of North Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Significant Change in Function from Baseline to Post-Treatment (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2017.