Pilot Trial of Microsphere Oxycodone (Xtampza ER) for Pain Management in Patients Receiving Radiotherapy for Locally Advanced Head and Neck Cancer

NCT03317730 | Completed Early Phase 1 FDA Drug

• 1 other identifier: IRB-300000574
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

To confirm the feasibility of studying Xtampza ER during radiotherapy (RT) for LAHNC as part of a prospective clinical trial.

Conditions

Locally Advanced Head and Neck Cancer

Keywords

Xtampza ER; LAHNC; Head and neck cancer; Pain management

Outcome Measures

Primary Outcomes (1)

• Feasibility of Xtampza ER during radiotherapy (RT) for locally advanced head and neck cancer (LAHNC).

  Feasibility of administering Xtampza ER during RT is defined as continuation of the medication throughout RT. The number of patients who discontinue Xtampza ER due to difficulty with administration, perceived inefficacy, or toxicity will be recorded.

  1 year

Secondary Outcomes (5)

• Determine Pain Control (at time of enrollment)

  1 year

• Determine Pain Control (weekly during RT)

  1 year

• Determine Pain Control (at follow-up)

  1 year

• Access Toxicity

  1 year

• Access Quality of Life

  1 year

Study Arms (1)

RT + Xtampza ER

EXPERIMENTAL

This study will enroll patients scheduled to receive radiation therapy (RT), but RT details are not specified by this protocol. Patients taking long acting opioid analgesics prior to enrollment will be converted to an equivalent dose of Xtampza ER at the time of enrollment. For the remaining patients not previously prescribed opioid analgesics, Xtampza ER will be initiated when 2 or more daily doses of short acting opioids are required, resulting in a total daily dose of at least 30mg morphine sulfate equivalent. During RT, pain will be assessed on a weekly basis using the PI-NRS and the dose of Xtampza ER will be adjusted at the discretion of the treating physician, with recommendation to maintain an equivalent of 100% daily opioid requirement. Assessment for tapering of Xtampza ER will begin 1 month following the completion of RT at the time of first follow-up.The study period will end 3 months following the final fraction of RT.

Drug: Xtampza ER

Interventions

Xtampza ER DRUG

Xtampza ER is a wax microsphere formulation of oxycodone that results in a nearly identical pharmacokinetic profile regardless of whether the capsule is intact when ingested or if ingested via enteral feeding tube as opposed to by mouth.

RT + Xtampza ER

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed locally advanced cancer of mucosa of the head and neck.
• Eligible subsites will include nasal cavity, paranasal sinuses, nasopharynx, oropharynx, oral cavity, major salivary glands, oropharynx, larynx, hypopharynx, cervical esophagus, or unknown primary site with lymph node metastases.
• Clinical or pathologic stage III-IV
• Scheduled to receive RT with curative intent with the expectation that some portion of the mucosa of the upper aerodigestive tract will receive a dose of at least 50 Gray.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
• Age \> 19 years
• Subjects given written informed consent

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

Hazelrig-Salter Radiation Oncology Center

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Agnosia

Interventions

Oxycodone

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor - Department of Radiation Oncology

Study Record Dates

• First Submitted: October 11, 2017
• First Posted: October 23, 2017
• Study Start: May 1, 2018
• Primary Completion: December 4, 2019
• Study Completion: November 17, 2020
• Last Updated: July 20, 2021

Record last verified: 2021-07

Locations

US (1)