Head and Neck CarcinomaPhase 2NCT05077072
Interdisciplinary Interventions to Address Pain Management Among Head and Neck Cancer Patients
A Phase 2 study testing Best Practice, Counseling and Electroencephalography in people with Head and Neck Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This phase II trial compares different pain management interventions (standard of care [SOC], neurofeedback [NFB] training, and compassionate high alert team [CHAT]) in patients diagnosed with head and neck cancer who are at risk of developing non-medical opioid use (NMOU). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Carcinoma
- What is being tested?
- Best Practice, Counseling and Electroencephalography
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Oct 2021to 31 Oct 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of HNC, with patient scheduled to receive radiation therapy, with or without evidence of active disease
- Willingness to be seen in the outpatient supportive care center (SCC)
- History of use of non-medical opioid use (Screener and Opioid Assessment for Patients with Pain [SOAPP] >= 7+ and/or Cut Down, Annoyed, Guilty, and Eye opener questionnaire [CAGE] >= 2+)
- Physician-estimated prognosis of at least 12 months
- Age 18 or older
- Able to complete study assessments
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- Willing to sign written informed consent
- Both human papillomavirus (HPV) and non-HPV patients will be included
- Patients currently receiving opioids for at least 1 week
- Able to read, write and speak English
Who cannot join
- Individual with clinically evident impaired cognition by Memorial Delirium Assessment Scale (MDAS) score of >= 13
- Employees of MD Anderson Cancer Center
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Opioid-Sparing Interdisciplinary Interventions Addressing Pain in Head and Neck Cancer Patients
This phase II trial compares different pain management interventions (standard of care [SOC], neurofeedback [NFB] training, and compassionate high alert team [CHAT]) in patients diagnosed with head and neck cancer who are at risk of developing non-medical opioid use (NMOU). The current standard treatment includes regular clinic visits and supportive care and counseling (including topics like patient-doctor communication, cancer care goals, financial issues counseling, and other topics). NFB training is a type of therapy that uses an electroencephalograph (EEG) and a computer software program to measure brain wave activity. The goal of NFB is to help teach patients with pain how to change their own brain waves to lower their feelings of pain and help improve their quality of life. CHAT is a supportive care intervention that includes symptom and pain management, counseling (about pain, symptoms, opioid use and safety, stress, and quality of life), and support for patients and their family members. NFB and CHAT may help to manage pain and lower patient use of opioids.
Read the detailed description
PRIMARY OBJECTIVE:
- To test the hypothesis that this study will be feasible, as defined by adequate rates of adherence in the CHAT and NFB groups.
SECONDARY OBJECTIVES:
- To examine the frequency of NMOU behaviors at the end of 3 months after CHAT, NFB, and SOC.
II. Examine the pain severity (area under the curve [AUC]), daily opioid use AUC of the cumulative morphine equivalent daily dose (MEDD), and mood (Hospital Anxiety and Depression Scale, HADS) for each of the treatment arms (CHAT, NFB, or SOC) in head and neck cancer (HNC) patients receiving radiation therapy at the end of 3 months.
EXPLORATORY OBJECTIVE:
- To examine the cortical and subcortical regions of the brain associated with pain and our interventions (CHAT, NFB, and SOC) and the extent to which changes in electroencephalogram (EEG) patterns mediate the effects of the intervention.
OUTLINE: Patients are randomized into 1 of 3 arms.
ARM I: Patients participate in CHAT counseling intervention over 45-60 minutes twice a month for up to 12 weeks.
ARM II: Patients undergo NFB intervention over 20-30 minutes twice a week for up to 10 weeks.
ARM III: Patients receive 2-3 standard of care sessions per month over 45-60 minutes for up to 12 weeks.
- Conditions
- Head and Neck Carcinoma
- Being tested
- Best Practice, Counseling, Electroencephalography, Neurofeedback, Questionnaire Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Receive SOC
CounselingOther
Also called Counseling Intervention
Participate in CHAT counseling intervention
ElectroencephalographyProcedure or surgery
Also called EEG, electroencephalogram
Undergo EEG
NeurofeedbackBehavioural
Also called EEG biofeedback
Undergo NFB intervention
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| ARM I (CHAT) | Experimental | Patients participate in CHAT counseling intervention over 45-60 minutes twice a month for up to 12 weeks. Receives: Other: Counseling; Other: Questionnaire Administration |
| ARM II (NFB) | Experimental | Patients undergo NFB intervention over 20-30 minutes twice a week for up to 10 weeks. Receives: Procedure: Electroencephalography; Behavioral: Neurofeedback; Other: Questionnaire Administration |
| ARM III (SOC) | Active comparator | Patients receive 2-3 standard of care sessions per month over 45-60 minutes for up to 12 weeks. Receives: Other: Best Practice; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of non-medical opioid use (NMOU) behaviors
Composite NMOU score is calculated by summing the number of times each behavior suggestive of NMOU is recorded.
Measured: through study completion, an average of a year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2021
- Study start8 Oct 2021
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CarcinomaStudies 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sriram Yennu, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05077072
- Sponsor's protocol ID
- 2021-0337
- Other IDs
- NCI-2021-09426, 2021-0337
- Status last verified
- Oct 2026
- First submitted
- 22 Sep 2021
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opioid-Sparing Interdisciplinary Interventions Addressing Pain in Head and Neck Cancer Patients
- ClinicalTrials.gov ID
- NCT05077072
- Acronym / sponsor ID
- 2021-0337
- Conditions
- Head and Neck Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 28 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 8 Oct 2021 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 13 Oct 2021 (actual)
- 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.
This phase II trial compares different pain management interventions (standard of care [SOC], neurofeedback [NFB] training, and compassionate high alert team [CHAT]) in patients diagnosed with head and neck cancer who are at risk of developing non-medical opioid use (NMOU). The current standard treatment includes regular clinic visits and supportive care and counseling (including topics like patient-doctor communication, cancer care goals, financial issues counseling, and other topics). NFB training is a type of therapy that uses an electroencephalograph (EEG) and a computer software program to measure brain wave activity. The goal of NFB is to help teach patients with pain how to change their own brain waves to lower their feelings of pain and help improve their quality of life. CHAT is a supportive care intervention that includes symptom and pain management, counseling (about pain, symptoms, opioid use and safety, stress, and quality of life), and support for patients and their family members. NFB and CHAT may help to manage pain and lower patient use of opioids.
Detailed description
PRIMARY OBJECTIVE:
- To test the hypothesis that this study will be feasible, as defined by adequate rates of adherence in the CHAT and NFB groups.
SECONDARY OBJECTIVES:
- To examine the frequency of NMOU behaviors at the end of 3 months after CHAT, NFB, and SOC.
II. Examine the pain severity (area under the curve [AUC]), daily opioid use AUC of the cumulative morphine equivalent daily dose (MEDD), and mood (Hospital Anxiety and Depression Scale, HADS) for each of the treatment arms (CHAT, NFB, or SOC) in head and neck cancer (HNC) patients receiving radiation therapy at the end of 3 months.
EXPLORATORY OBJECTIVE:
- To examine the cortical and subcortical regions of the brain associated with pain and our interventions (CHAT, NFB, and SOC) and the extent to which changes in electroencephalogram (EEG) patterns mediate the effects of the intervention.
OUTLINE: Patients are randomized into 1 of 3 arms.
ARM I: Patients participate in CHAT counseling intervention over 45-60 minutes twice a month for up to 12 weeks.
ARM II: Patients undergo NFB intervention over 20-30 minutes twice a week for up to 10 weeks.
ARM III: Patients receive 2-3 standard of care sessions per month over 45-60 minutes for up to 12 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ARM I (CHAT) | Experimental | Other: Counseling, Other: Questionnaire AdministrationPatients participate in CHAT counseling intervention over 45-60 minutes twice a month for up to 12 weeks. |
| ARM II (NFB) | Experimental | Procedure: Electroencephalography, Behavioral: Neurofeedback, Other: Questionnaire AdministrationPatients undergo NFB intervention over 20-30 minutes twice a week for up to 10 weeks. |
| ARM III (SOC) | Active comparator | Other: Best Practice, Other: Questionnaire AdministrationPatients receive 2-3 standard of care sessions per month over 45-60 minutes for up to 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Diagnosis of HNC, with patient scheduled to receive radiation therapy, with or without evidence of active disease
- Willingness to be seen in the outpatient supportive care center (SCC)
- History of use of non-medical opioid use (Screener and Opioid Assessment for Patients with Pain [SOAPP] >= 7+ and/or Cut Down, Annoyed, Guilty, and Eye opener questionnaire [CAGE] >= 2+)
- Physician-estimated prognosis of at least 12 months
- Age 18 or older
Key exclusion criteria (2 listed)
- Individual with clinically evident impaired cognition by Memorial Delirium Assessment Scale (MDAS) score of >= 13
- Employees of MD Anderson Cancer Center
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 |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyReceive SOC | Other | ARM III (SOC) |
| CounselingAlso: Counseling InterventionParticipate in CHAT counseling intervention | Other | ARM I (CHAT) |
| ElectroencephalographyAlso: EEG, electroencephalogramUndergo EEG | Procedure or surgery | ARM II (NFB) |
| NeurofeedbackAlso: EEG biofeedbackUndergo NFB intervention | Behavioural | ARM II (NFB) |
| Questionnaire AdministrationAncillary studies | Other | ARM I (CHAT), ARM II (NFB), ARM III (SOC) |
Primary outcome
Frequency of non-medical opioid use (NMOU) behaviors
Time frame: through study completion, an average of a year.
Composite NMOU score is calculated by summing the number of times each behavior suggestive of NMOU is recorded.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- MD Anderson Cancer Center WebsiteLink 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.
Sriram Yennu 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 Phase 2 study testing Best Practice, Counseling and Electroencephalography in people with Head and Neck Carcinoma, 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 10 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: under way, not looking for participants, as of the sponsor's last update on 7 Oct 2026. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Frequency of non-medical opioid use (NMOU) behaviors (time frame: through study completion, an average of a year.). 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 7 Oct 2026.