Exploring the Neuro-Immune Basis of Cancer-Related Fatigue Using Behavioral Measures

March 28, 2024 updated by: M.D. Anderson Cancer Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

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
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Male patients at least 18 years old.
  2. Patients who completed either definitive or postoperative radiation or chemoradiation therapy for head and neck cancer within the past 6 weeks to 120 months.
  3. Patients who speak English.
  4. Patients who are willing and able to review, understand, and provide written consent.
  5. Patients who agree to comply with all study procedures.

Exclusion Criteria:

  1. Patients with clinical evidence of active persistent cancer or progressive disease after completing planned cancer therapy, or with active recurrent cancer.
  2. Patients with potential medical or other underlying causes of fatigue, as determined by the treating physician or Principal Investigator.
  3. Patients with underlying cardiac or pulmonary disease resulting in dyspnea, hypoxia, or hypercapnia.
  4. 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.
  5. Patients currently taking, or having taken within the previous 1 month, armodafinil, modafinil, amphetamine, or methylphenidate.
  6. Patients who are enrolled and receiving active treatment in a symptom intervention trial or who are in the treatment phase of a clinical trial.
  7. Patients experiencing moderate to severe pain (4 or higher on a 0 to 10 scale) at the time of screening.
  8. Patients who cannot distinguish between the red and blue stimuli of the set-switch task.

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

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: High-Fatigue Head and Neck (HNC) Cancer Survivors
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.
Behavioral: Computerized Tasks
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.
Behavioral: Questionnaires
Completion of 8 questionnaires about mood, fatigue, sleep quality, and other symptoms. It should take about 30 minutes to complete these questionnaires.
Other Names:
  • Surveys
Other: Low-Fatigue Head and Neck (HNC) Cancer Survivors
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.
Behavioral: Computerized Tasks
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.
Behavioral: Questionnaires
Completion of 8 questionnaires about mood, fatigue, sleep quality, and other symptoms. It should take about 30 minutes to complete these questionnaires.
Other Names:
  • Surveys

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Markers of Inflammation and Fatigue
Time Frame: 1 day
Frequency of each COMT genotype (Val/Val; Met/Met; Val/Met) compared between high-fatigue and low-fatigue survivors.
1 day

Collaborators and Investigators

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

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Robert Dantzer, DMV,PHD, M.D. Anderson Cancer Center

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)

November 4, 2014

Primary Completion (Actual)

March 27, 2024

Study Completion (Actual)

March 27, 2024

Study Registration Dates

First Submitted

September 26, 2014

First Submitted That Met QC Criteria

September 30, 2014

First Posted (Estimated)

October 3, 2014

Study Record Updates

Last Update Posted (Actual)

March 29, 2024

Last Update Submitted That Met QC Criteria

March 28, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-0511
  • NCI-2015-00012 (Registry Identifier: NCI CTRP)

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.

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