Head and Neck CancerNCT02255773
Exploring the Neuro-Immune Basis of Cancer-Related Fatigue Using Behavioral Measures
A study testing Computerized Tasks and Questionnaires in people with Head and Neck Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this research study is to learn more about fatigue and how it affects your behavior as well as your willingness to learn new behaviors. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Computerized Tasks and Questionnaires
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Nov 2014to 27 Mar 2024
- Phase
- Interventional
- 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 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male patients at least 18 years old.
- Patients who completed either definitive or postoperative radiation or chemoradiation therapy for head and neck cancer within the past 6 weeks to 120 months.
- Patients who speak English.
- Patients who are willing and able to review, understand, and provide written consent.
- Patients who agree to comply with all study procedures.
Who cannot join
- Patients with clinical evidence of active persistent cancer or progressive disease after completing planned cancer therapy, or with active recurrent cancer.
- Patients with potential medical or other underlying causes of fatigue, as determined by the treating physician or Principal Investigator.
- Patients with underlying cardiac or pulmonary disease resulting in dyspnea, hypoxia, or hypercapnia.
- Patients with major depressive disorder or severe depression (a score of 22 or greater on the Center for Epidemiologic Studies Depression (CES-D)); for scores of 16 or higher, we will notify the patient's treating physician within 1 working day of the screening to allow for appropriate management or referral.
- Patients currently taking, or having taken within the previous 1 month, armodafinil, modafinil, amphetamine, or methylphenidate.
- Patients who are enrolled and receiving active treatment in a symptom intervention trial or who are in the treatment phase of a clinical trial.
- Patients experiencing moderate to severe pain (4 or higher on a 0 to 10 scale) at the time of screening.
- Patients who cannot distinguish between the red and blue stimuli of the set-switch task.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
The goal of this research study is to learn more about fatigue and how it affects your behavior as well as your willingness to learn new behaviors.
Read the detailed description
If you agree to take part in this study, the following tests and procedures will be performed:
- Blood (about 3 teaspoons) will be drawn to test for markers of inflammation and to test for genes related to brain signaling. Markers of inflammation are found in the blood and may be related to your fatigue and other symptoms.
- You will complete three tasks on a computer. Some of the tasks are easy and you are already used to them, but other ones will require some learning. You will be given written instructions on how to complete them. The tasks will be completed in or near the Head and Neck Cancer outpatient clinics. It should take about 60 minutes to complete all three tasks.
- You will complete 9 questionnaires about your mood, fatigue, sleep quality, and other symptoms. It should take about 30 minutes to complete these questionnaires.
The questionnaires will be given a code number and stored in a locked file cabinet at MD Anderson. No identifying information will be directly linked to your questionnaires. Only the researcher in charge of the study will have access to the code numbers and be able to link the questionnaires to you.
Length of Study:
After you have completed the blood draw, the computerized tasks, and the questionnaires, your participation on this study will be over.
Additional Information:
Any information about your symptoms that is collected as part of this study is for research purposes only. The questionnaires will only be used for the purposes of this study and will be destroyed after the study results have been reported.
If you describe a symptom as being severe on the symptom questionnaire, a study staff member will ask you if you have already told or plan to tell your doctor or nurse about the symptom. If you have not already told your doctor or nurse, a study staff member will tell your doctor or nurse about the symptom for you.
This is an investigational study.
Up to 60 participants will be enrolled in this study. All will take part at MD Anderson.
- Conditions
- Head and Neck Cancer
- Being tested
- Computerized Tasks, Questionnaires
- Keywords
- Head and Neck Cancer, HNC, Moderate to severe fatigue, Computerized tasks, Questionnaires, Surveys, Disease-free adult males, Cancer survivors
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized TasksBehavioural
3 computerized tasks completed to assess motivation, learning of goal-directed and habitual behavior, and flexibility in switching between behavior strategies. It should take about 60 minutes to complete all three tasks.
QuestionnairesBehavioural
Also called Surveys
Completion of 8 questionnaires about mood, fatigue, sleep quality, and other symptoms. It should take about 30 minutes to complete these questionnaires.
| Study group | Role | What they receive |
|---|---|---|
| High-Fatigue Head and Neck (HNC) Cancer Survivors | Other | Participants undergo assessment with three validated computerized tasks designed to measure the neurobehavioral domains of interest: the Effort Expenditure for Rewards Task (EEfRT), an associative learning task, and a set-switch task. Participants complete questionnaires assessing mood, somatic symptoms, and sleep quality, including the Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF), the Checklist Individual Strength (CIS), and others. A 10-mL blood sample drawn for assessment of inflammatory markers and COMT and DAT1 genotype. Receives: Behavioral: Computerized Tasks; Behavioral: Questionnaires |
| Low-Fatigue Head and Neck (HNC) Cancer Survivors | Other | Participants undergo assessment with three validated computerized tasks designed to measure the neurobehavioral domains of interest: the Effort Expenditure for Rewards Task (EEfRT), an associative learning task, and a set-switch task. Participants complete questionnaires assessing mood, somatic symptoms, and sleep quality, including the Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF), the Checklist Individual Strength (CIS), and others. A 10-mL blood sample drawn for assessment of inflammatory markers and COMT and DAT1 genotype. Receives: Behavioral: Computerized Tasks; Behavioral: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue Comparison in Male Head and Neck Cancer Survivors
Endpoint for Effort Expenditure for Rewards Task (EEfRT) is ratio of hard task choices (number of hard task choices/total choices) across levels of probability. Endpoints for associative learning task are number of trials until reaching the a priori defined learning criterion (three consecutive correct responses for each association), indicating goal-directed learning, and number of trials between reaching this criterion and reaching asymptote in the reaction times, indicating establishment of habitual behavior. Set-switching task primary endpoints is difference in reaction times and number of errors between "no-switch" and "switch" trials.
Measured: 1 day
Secondary outcomes (1)
Markers of Inflammation and Fatigue
Frequency of each COMT genotype (Val/Val; Met/Met; Val/Met) compared between high-fatigue and low-fatigue survivors.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2014 (estimated)
- Study start4 Nov 2014
- Primary completion27 Mar 2024
- Study completion27 Mar 2024
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 M.D. Anderson 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Dantzer, DMV,PHD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02255773
- Sponsor's protocol ID
- 2014-0511
- Other IDs
- NCI-2015-00012
- Status last verified
- Mar 2024
- First submitted
- 26 Sep 2014
- Last updated
- 29 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Neuro-Immune Basis of Cancer-Related Fatigue Using Behavioral Measures
- ClinicalTrials.gov ID
- NCT02255773
- Acronym / sponsor ID
- 2014-0511
- Conditions
- Head and Neck Cancer
- Keywords
- Head and Neck Cancer, HNC, Moderate to severe fatigue, Computerized tasks, Questionnaires, Surveys, Disease-free adult males, Cancer survivors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 4 Nov 2014 (actual)
- Primary completion
- 27 Mar 2024 (actual)
- Study completion
- 27 Mar 2024 (actual)
- First posted
- 3 Oct 2014 (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.
The goal of this research study is to learn more about fatigue and how it affects your behavior as well as your willingness to learn new behaviors.
Detailed description
If you agree to take part in this study, the following tests and procedures will be performed:
- Blood (about 3 teaspoons) will be drawn to test for markers of inflammation and to test for genes related to brain signaling. Markers of inflammation are found in the blood and may be related to your fatigue and other symptoms.
- You will complete three tasks on a computer. Some of the tasks are easy and you are already used to them, but other ones will require some learning. You will be given written instructions on how to complete them. The tasks will be completed in or near the Head and Neck Cancer outpatient clinics. It should take about 60 minutes to complete all three tasks.
- You will complete 9 questionnaires about your mood, fatigue, sleep quality, and other symptoms. It should take about 30 minutes to complete these questionnaires.
The questionnaires will be given a code number and stored in a locked file cabinet at MD Anderson. No identifying information will be directly linked to your questionnaires. Only the researcher in charge of the study will have access to the code numbers and be able to link the questionnaires to you.
Length of Study:
After you have completed the blood draw, the computerized tasks, and the questionnaires, your participation on this study will be over.
Additional Information:
Any information about your symptoms that is collected as part of this study is for research purposes only. The questionnaires will only be used for the purposes of this study and will be destroyed after the study results have been reported.
If you describe a symptom as being severe on the symptom questionnaire, a study staff member will ask you if you have already told or plan to tell your doctor or nurse about the symptom. If you have not already told your doctor or nurse, a study staff member will tell your doctor or nurse about the symptom for you.
This is an investigational study.
Up to 60 participants will be enrolled in this study. All will take part at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-Fatigue Head and Neck (HNC) Cancer Survivors | Other | Behavioral: Computerized Tasks, Behavioral: QuestionnairesParticipants undergo assessment with three validated computerized tasks designed to measure the neurobehavioral domains of interest: the Effort Expenditure for Rewards Task (EEfRT), an associative learning task, and a set-switch task. Participants complete questionnaires assessing mood, somatic symptoms, and sleep quality, including the Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF), the Checklist Individual Strength (CIS), and others. A 10-mL blood sample drawn for assessment of inflammatory markers and COMT and DAT1 genotype. |
| Low-Fatigue Head and Neck (HNC) Cancer Survivors | Other | Behavioral: Computerized Tasks, Behavioral: QuestionnairesParticipants undergo assessment with three validated computerized tasks designed to measure the neurobehavioral domains of interest: the Effort Expenditure for Rewards Task (EEfRT), an associative learning task, and a set-switch task. Participants complete questionnaires assessing mood, somatic symptoms, and sleep quality, including the Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF), the Checklist Individual Strength (CIS), and others. A 10-mL blood sample drawn for assessment of inflammatory markers and COMT and DAT1 genotype. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male patients at least 18 years old.
- Patients who completed either definitive or postoperative radiation or chemoradiation therapy for head and neck cancer within the past 6 weeks to 120 months.
- Patients who speak English.
- Patients who are willing and able to review, understand, and provide written consent.
- Patients who agree to comply with all study procedures.
Key exclusion criteria (8 listed)
- Patients with clinical evidence of active persistent cancer or progressive disease after completing planned cancer therapy, or with active recurrent cancer.
- Patients with potential medical or other underlying causes of fatigue, as determined by the treating physician or Principal Investigator.
- Patients with underlying cardiac or pulmonary disease resulting in dyspnea, hypoxia, or hypercapnia.
- Patients with major depressive disorder or severe depression (a score of 22 or greater on the Center for Epidemiologic Studies Depression (CES-D)); for scores of 16 or higher, we will notify the patient's treating physician within 1 working day of the screening to allow for appropriate management or referral.
- Patients currently taking, or having taken within the previous 1 month, armodafinil, modafinil, amphetamine, or methylphenidate.
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 |
|---|---|---|
| Computerized Tasks3 computerized tasks completed to assess motivation, learning of goal-directed and habitual behavior, and flexibility in switching between behavior strategies. It should take about 60 minutes to complete all three tasks. | Behavioural | High-Fatigue Head and Neck (HNC) Cancer Survivors, Low-Fatigue Head and Neck (HNC) Cancer Survivors |
| QuestionnairesAlso: SurveysCompletion of 8 questionnaires about mood, fatigue, sleep quality, and other symptoms. It should take about 30 minutes to complete these questionnaires. | Behavioural | High-Fatigue Head and Neck (HNC) Cancer Survivors, Low-Fatigue Head and Neck (HNC) Cancer Survivors |
Primary outcome
Fatigue Comparison in Male Head and Neck Cancer Survivors
Time frame: 1 day
Endpoint for Effort Expenditure for Rewards Task (EEfRT) is ratio of hard task choices (number of hard task choices/total choices) across levels of probability. Endpoints for associative learning task are number of trials until reaching the a priori defined learning criterion (three consecutive correct responses for each association), indicating goal-directed learning, and number of trials between reaching this criterion and reaching asymptote in the reaction times, indicating establishment of habitual behavior. Set-switching task primary endpoints is difference in reaction times and number of errors between "no-switch" and "switch" trials.
1 secondary outcome
Markers of Inflammation and Fatigue
Time frame: 1 day
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 29 Mar 2024.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
Related trials for Head and Neck Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
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.
Robert Dantzer, DMV,PHD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computerized Tasks and Questionnaires in people with Head and Neck Cancer, run by M.D. Anderson 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 5 inclusion and 8 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 29 Mar 2024. 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?
Fatigue Comparison in Male Head and Neck Cancer Survivors (time frame: 1 day). 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 29 Mar 2024.