Recruiting

Methadone & Fentanyl

Sponsor:

OHSU Knight Cancer Institute

Code:

NCT07857655

Conditions

Head and Neck Carcinoma

Hypopharyngeal Carcinoma

Laryngeal Carcinoma

Oral Cavity Carcinoma

Oropharyngeal Carcinoma

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Electronic Health Record Review

Fentanyl

Laryngoscopy

Methadone

Surgical Procedure

Study Details

Brief summary:

This phase IV trial compares how well methadone plus standard fentanyl given during surgery (intraoperative) works compared to intraoperative standard fentanyl alone in managing pain after surgery (postoperative) among patients with head and neck cancers. For most head and neck cancers, the standard treatment is surgery to remove the cancer followed by surgical reconstruction, which often requires tissue harvested from another part of the body-known as a "free flap tissue transfer". These procedures are highly complex, demand a two-surgeon team, and often take many hours to complete. The combination of multiple operative sites and extent of the surgery contributes to significant postoperative pain. Methadone is not yet used in the head and neck population but has been utilized in other subspecialties like spine and cardiac surgery. The benefits of methadone may include improved pain control in the first 72 hours postoperatively requiring less opioids postoperatively and improvement in overall pain scores. Giving intraoperative methadone plus standard fentanyl may work better than fentanyl alone in managing postoperative pain among patients with head and neck cancers.

Conditions

Head and Neck Carcinoma

Hypopharyngeal Carcinoma

Laryngeal Carcinoma

Oral Cavity Carcinoma

Oropharyngeal Carcinoma

Study ID

NCT07857655

Start date

Sep 22, 2026

Status verified date

Sep, 2026

Completion date

Jul 29, 2029

Anticipated

Primary completion date

Jul 29, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adults 18-89
  • Patients with biopsy proven head and neck cancer\*. Diagnosis will be confirmed by Otolaryngology-Head and Neck Surgery (OTOHNS) team at our center

  • Oral cavity, oropharyngeal, hypopharyngeal, laryngeal
  • Undergoing surgical intervention with ablative and/or reconstructive OTOHNS surgeons for one of the following:

  • Free flap reconstruction (single or double flaps including: radial forearm free flap \[RFFF\], osteocutaneous radial forearm flap \[OCRFF\], fibula free flap \[FFF\], anterolateral thigh \[ALT\], scapula flap, latissimus, gracilis, rectus sheath, pectoralis)
  • Resections with pedicled flaps (e.g., pectoralis major, latissimus) with an expected case time of > 4 hours

  • Expected time of surgery is found in the surgery request and in our department, the surgeon puts in these orders

Exclusion Criteria:

  • Patients will be excluded if they do not consent, are minors, are deemed part of a vulnerable population or lack decision-making capacity
  • Current use of long-acting opioids
  • Pain patients treated with opioids for pathology unrelated to head and neck cancer and/or chronic pain patients, i.e. chronic back pain
  • Positive screening at interview for illicit drug use, not including marijuana

  • Drug screening is not routinely acquired prior to anesthesia per our institution's standard of care and policies. Any suspected abuse or use is guided by clinical evaluation. Patients with evidence of acute intoxication or concern for prior abuse history will be excluded per clinical judgement
  • Contraindications to methadone (American Society of Addiction Medicine \[ASAM\] criteria): hypersensitivity, severe respiratory depression, paralytic ileus - in which only hypersensitivity is relevant, since individuals undergoing surgery would not present with the latter
  • Currently on CYP therapies noted in the Food and Drug Administration (FDA) methadone pamphlet to have either decreased efficacy of therapy or reduced metabolism of methadone with concurrent use

  • Rifampin, phenytoin, phenobarbital, carbamazepine, voriconazole, abacavir, amprenavir, darunavir+ritonavir, efavirenz, nelfinavir, nevirapine, ritonavir, telaprevir, lopinavir+ritonavir, saquinavir+ritonavir, tipranavir+ritonavir combination, didanosine, stavudine, zidovudine
  • Extensive surgical interventions that require additional assistance from outside services at the time of reconstruction (i.e. hypopharyngeal cancer also requiring esophagectomy)
  • Head and neck cancers with intracranial components (direct, primary tumor extension, metastatic disease)
  • Body mass index (BMI) > 40
  • Sleep apnea with an apnea-hypopnea index > 30 without planned tracheostomy
  • Stage 3b chronic kidney disease or higher (estimated glomerular filtration rate < 45)
  • Aspartate aminotransferase/alanine aminotransferase (AST/ALT) greater than two times the upper limit of normal
  • Patients with a history of corrected QT interval (QTc) prolongation > 500 ms

Study Design

Enrollment

58 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Arm I (methadone, fentanyl)

Patients receive methadone IV at the time of incision during SOC surgery. Patients also receive SOC fentanyl prior to SOC laryngoscopy procedure.

active comparator: Arm II (fentanyl)

Patients receive SOC fentanyl prior to SOC laryngoscopy procedure and surgery.

Interventions

Electronic Health Record Review

Ancillary studies

Fentanyl

Given SOC fentanyl

Laryngoscopy

Undergo SOC laryngoscopy

Methadone

Given IV

Surgical Procedure

Undergo SOC surgery

Survey Administration

Ancillary studies

Primary outcome measure

  • Total morphine milligram equivalents (MMEs) administered in the first 24 hours postoperatively [ Time Frame: From out of room to 24 hours postoperatively ]

Central Contacts and Locations

Locations

OHSU Knight Cancer Institute

Recruiting

Portland, Oregon, United States, 97239

Contacts

Ryan N. Hellums

503-494-5355hellums@ohsu.edu

Principal Investigator:

Ryan N. Hellums

More Information

Sponsor

OHSU Knight Cancer Institute

Last update posted

Oct 5, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-06. This information was provided to ClinicalTrials.gov by OHSU Knight Cancer Institute on 2026-10-05. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.