Clinical Data Collection in Studying Clinical Factors Associated With Post-Surgery Chronic Opioid Use in Patients With Head and Neck Cancers

September 10, 2026 updated by: M.D. Anderson Cancer Center

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. 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:

I. 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 Type

Observational

Enrollment (Estimated)

125

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
        • M D 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

No

Sampling Method

Non-Probability Sample

Study Population

MD Anderson Cancer Participants

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patient not willing to participate
  • Not competent to give informed consent
  • Inability to read and write in English

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: Questionnaire Administration
Complete questionnaire
Other: Quality-of-Life Assessment
Complete quality of life assessment
Other Names:
  • Quality of Life Assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
At 90 days after surgery
Severity of symptom burden
Time Frame: At 90 days after surgery
Will be measured by MDASI.
At 90 days after surgery
Association of chronic opioid use
Time Frame: At 90 days after surgery
Association of chronic opioid use with that of the CAGE-AID scores
At 90 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Risk of opioid use assessed
Time Frame: Up to 90 days after surgery
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.
Up to 90 days after surgery
Frequency of positive risk of opioid use disorder
Time Frame: Up to 90 days post surgery
Will be assessed by Screener and Opioid Assessment for Patients with Pain[SOAPP-14.
Up to 90 days post surgery
Frequency of aberrant opioid use behaviors
Time Frame: Up to 90 days post surgery
Correlation between categorical variables will be evaluated using Chisquare test or Fisher's exact test.
Up to 90 days post surgery
Frequency of post-operative complications
Time Frame: Up to 90 days post surgery
Correlation between categorical variables will be evaluated using Chisquare test or Fisher's exact test
Up to 90 days post surgery
Risk of opioid use will be assessed by CAGE-AID
Time Frame: Up to 90 days post surgery
CAGE-AID: Score of greater than or equal 2 is considered as risk factor for opioid misuse
Up to 90 days post surgery
Frequency of positive risk of opioid use disorder
Time Frame: Up to 90 days post surgery
Will be assessed by CAGE-adapted to include drugs (AID).
Up to 90 days post surgery

Collaborators and Investigators

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

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Lakshmi Koyyalagunta, 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)

January 25, 2019

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

April 30, 2027

Study Registration Dates

First Submitted

January 16, 2019

First Submitted That Met QC Criteria

March 22, 2019

First Posted (Actual)

March 25, 2019

Study Record Updates

Last Update Posted (Actual)

September 14, 2026

Last Update Submitted That Met QC Criteria

September 10, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-0740 (Other Identifier: M D Anderson Cancer Center)
  • P30CA016672 (U.S. NIH Grant/Contract)
  • NCI-2018-03357 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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