Head and Neck CarcinomaNCT03888651
Clinical Data Collection in Studying Clinical Factors Associated With Post-Surgery Chronic Opioid Use in Patients With Head and Neck Cancers
An observational study of Head and Neck Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This trial studies the risk of developing disorders associated with chronic opioid use post-surgery in patients with head and neck cancers. Clinical data collection may help doctors to learn how often and how likely disorders associated with the use of opioid pain medication may occur in patients with head and neck… 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?
- Quality-of-Life Assessment and Questionnaire Administration
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jan 2019to 30 Apr 2027
- Phase
- Observational
- 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
Study population: MD Anderson Cancer Participants
Who may be able to join
- Patients with head and neck cancer scheduled for combined head and neck surgery - plastic surgery free flap
- Competent to give informed consent
- Ability to read and write in English
Who cannot join
- Patient not willing to participate
- Not competent to give informed consent
- Inability to read and write in English
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Investigation of Postoperative Chronic Opioid Use and Its Associations With Other Clinical Factors Among Patients With Head and Neck Cancers
This trial studies the risk of developing disorders associated with chronic opioid use post-surgery in patients with head and neck cancers. Clinical data collection may help doctors to learn how often and how likely disorders associated with the use of opioid pain medication may occur in patients with head and neck cancer who are having surgery as part of their treatment plan.
Read the detailed description
PRIMARY OBJECTIVES:
- Assess prevalence of chronic opioid use and severity of symptom burden (M. D. Anderson Symptom Inventory-Head and Neck [MDASI-HN]) in patients undergoing surgery of head/neck cancer.
SECONDARY OBJECTIVES:
- To investigate the extent of association of chronic opioid use with risk of opioid use disorder (as assessed by Screener and Opioid Assessment for Patients with Pain[SOAPP-14] and Cut down, Annoyed, Guilty and Eye Opener [CAGE] scores) and psychosocial factors (as assessed by MDASI).
II. To assess frequency of positive risk of opioid use disorder as assessed by Screener and Opioid Assessment for Patients tool (SOAPP-14) and CAGE-adapted to include drugs (AID).
III. Assess frequency of aberrant opioid use behaviors. IV. Assess frequency of post-operative complications.
OUTLINE:
Patients complete questionnaires and quality of life assessments over 10-15 minutes at pre-surgery, after-surgery, at discharge, within 2-3 weeks after surgery, and within 90 days after surgery.
- Conditions
- Head and Neck Carcinoma
- Being tested
- Quality-of-Life Assessment, Questionnaire Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Complete quality of life assessment
Questionnaire AdministrationOther
Complete questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Observational (questionnaires, quality of life assessment) | Patients complete questionnaires and quality of life assessments over 10-15 minutes at pre-surgery, after-surgery, at discharge, within 2-3 weeks after surgery, and within 90 days after surgery. Receives: Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of chronic opioid use
Rate of chronic opioid use will be measured by the association of chronic opioid use with that of the risk of opioid misuse Screener and Opioid Assessment for Patients tool (SOAPP-14)
Measured: At 90 days after surgery
Severity of symptom burden
Will be measured by MDASI.
Measured: At 90 days after surgery
Association of chronic opioid use
Association of chronic opioid use with that of the CAGE-AID scores
Measured: At 90 days after surgery
Secondary outcomes (6)
Risk of opioid use assessed
Screener and Opioid Assessment for Patients with Pain[SOAPP-14] Score of greater than or equal 7 is considered as risk factor for opioid misuse.
Measured: Up to 90 days after surgery
Frequency of positive risk of opioid use disorder
Will be assessed by Screener and Opioid Assessment for Patients with Pain[SOAPP-14.
Measured: Up to 90 days post surgery
Frequency of aberrant opioid use behaviors
Correlation between categorical variables will be evaluated using Chisquare test or Fisher's exact test.
Measured: Up to 90 days post surgery
Frequency of post-operative complications
Correlation between categorical variables will be evaluated using Chisquare test or Fisher's exact test
Measured: Up to 90 days post surgery
Risk of opioid use will be assessed by CAGE-AID
CAGE-AID: Score of greater than or equal 2 is considered as risk factor for opioid misuse
Measured: Up to 90 days post surgery
Frequency of positive risk of opioid use disorder
Will be assessed by CAGE-adapted to include drugs (AID).
Measured: Up to 90 days post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2019
- Study start25 Jan 2019
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Lakshmi Koyyalagunta, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03888651
- Sponsor's protocol ID
- 2018-0740
- Other IDs
- NCI-2018-03357, 2018-0740, P30CA016672
- Status last verified
- Sep 2026
- First submitted
- 16 Jan 2019
- Last updated
- 14 Sep 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 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation of Postoperative Chronic Opioid Use and Its Associations With Other Clinical Factors Among Patients With Head and Neck Cancers
- ClinicalTrials.gov ID
- NCT03888651
- Acronym / sponsor ID
- 2018-0740
- Conditions
- Head and Neck Carcinoma
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 25 Jan 2019 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 25 Mar 2019 (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 trial studies the risk of developing disorders associated with chronic opioid use post-surgery in patients with head and neck cancers. Clinical data collection may help doctors to learn how often and how likely disorders associated with the use of opioid pain medication may occur in patients with head and neck cancer who are having surgery as part of their treatment plan.
Detailed description
PRIMARY OBJECTIVES:
- Assess prevalence of chronic opioid use and severity of symptom burden (M. D. Anderson Symptom Inventory-Head and Neck [MDASI-HN]) in patients undergoing surgery of head/neck cancer.
SECONDARY OBJECTIVES:
- To investigate the extent of association of chronic opioid use with risk of opioid use disorder (as assessed by Screener and Opioid Assessment for Patients with Pain[SOAPP-14] and Cut down, Annoyed, Guilty and Eye Opener [CAGE] scores) and psychosocial factors (as assessed by MDASI).
II. To assess frequency of positive risk of opioid use disorder as assessed by Screener and Opioid Assessment for Patients tool (SOAPP-14) and CAGE-adapted to include drugs (AID).
III. Assess frequency of aberrant opioid use behaviors. IV. Assess frequency of post-operative complications.
OUTLINE:
Patients complete questionnaires and quality of life assessments over 10-15 minutes at pre-surgery, after-surgery, at discharge, within 2-3 weeks after surgery, and within 90 days after surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (questionnaires, quality of life assessment) | – | Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients complete questionnaires and quality of life assessments over 10-15 minutes at pre-surgery, after-surgery, at discharge, within 2-3 weeks after surgery, and within 90 days after surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- MD Anderson Cancer Participants
Key inclusion criteria (3 listed)
- Patients with head and neck cancer scheduled for combined head and neck surgery - plastic surgery free flap
- Competent to give informed consent
- Ability to read and write in English
Key exclusion criteria (3 listed)
- Patient not willing to participate
- Not competent to give informed consent
- Inability to read and write in English
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 |
|---|---|---|
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentComplete quality of life assessment | Other | Observational (questionnaires, quality of life assessment) |
| Questionnaire AdministrationComplete questionnaire | Other | Observational (questionnaires, quality of life assessment) |
Primary outcome
Rate of chronic opioid use
Time frame: At 90 days after surgery
Rate of chronic opioid use will be measured by the association of chronic opioid use with that of the risk of opioid misuse Screener and Opioid Assessment for Patients tool (SOAPP-14)
Severity of symptom burden
Time frame: At 90 days after surgery
Will be measured by MDASI.
Association of chronic opioid use
Time frame: At 90 days after surgery
Association of chronic opioid use with that of the CAGE-AID scores
6 secondary outcomes
Risk of opioid use assessed
Time frame: Up to 90 days after surgery
Frequency of positive risk of opioid use disorder
Time frame: Up to 90 days post surgery
Frequency of aberrant opioid use behaviors
Time frame: Up to 90 days post surgery
Frequency of post-operative complications
Time frame: Up to 90 days post surgery
Risk of opioid use will be assessed by CAGE-AID
Time frame: Up to 90 days post surgery
Frequency of positive risk of opioid use disorder
Time frame: Up to 90 days post surgery
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 14 Sep 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.
Lakshmi Koyyalagunta 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?
An observational study of 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 3 inclusion and 3 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 14 Sep 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.
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?
Rate of chronic opioid use (time frame: At 90 days after surgery). The study lists 3 primary outcomes in all. 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 14 Sep 2026.