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Completed

NCT Number: NCT03317730

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

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

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Key information

Conditions

Locally Advanced Head and Neck Cancer Agnosia Head and Neck Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Hazelrig-Salter Radiation Oncology Center

Birmingham, Alabama, 35233, United States

About this study

To confirm the feasibility of studying Xtampza ER during radiotherapy (RT) for locally advanced head and neck cancer (LAHNC) as part of a prospective clinical trial. Investigators will also assess pain control, quality of life, and drug related toxicity during RT and during short term follow-up.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

-

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 1 year

    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.

Secondary outcomes

  1. Determine Pain Control (at time of enrollment)

    Time frame: 1 year

    Pain will be assessed using:

    Pain Intensity Numeric Rating Scale - a scale of 0-10, with 0 being no pain and 10 being worst possible pain.

    Brief Pain Inventory - a patient completed 2-page questionnaire rating severity of pain and how pain interferes with functioning. The pain severity score is calculated by averaging the 4 questions related to this topic (each question is a 0-10 scale, with higher numbers indicating worse pain). The pain interference score is calculated by averaging the 7 questions related to this topic (each question is a 0-10 scale, with higher numbers indicating worse functional interference). The remaining items included in the Brief Pain Inventory will be recorded but do not contribute to a score.

  2. Determine Pain Control (weekly during RT)

    Time frame: 1 year

    Pain will be assessed using:

    Pain Intensity Numeric Rating Scale - a scale of 0-10, with 0 being no pain and 10 being worst possible pain.

    Brief Pain Inventory - a patient completed 2-page questionnaire rating severity of pain and how pain interferes with functioning. The pain severity score is calculated by averaging the 4 questions related to this topic (each question is a 0-10 scale, with higher numbers indicating worse pain). The pain interference score is calculated by averaging the 7 questions related to this topic (each question is a 0-10 scale, with higher numbers indicating worse functional interference). The remaining items included in the Brief Pain Inventory will be recorded but do not contribute to a score.

  3. Determine Pain Control (at follow-up)

    Time frame: 1 year

    Pain will be assessed using:

    Pain Intensity Numeric Rating Scale - a scale of 0-10, with 0 being no pain and 10 being worst possible pain.

    Brief Pain Inventory - a patient completed 2-page questionnaire rating severity of pain and how pain interferes with functioning. The pain severity score is calculated by averaging the 4 questions related to this topic (each question is a 0-10 scale, with higher numbers indicating worse pain). The pain interference score is calculated by averaging the 7 questions related to this topic (each question is a 0-10 scale, with higher numbers indicating worse functional interference). The remaining items included in the Brief Pain Inventory will be recorded but do not contribute to a score.

  4. Access Toxicity

    Time frame: 1 year

    Toxicity will be assessed using the Common Terminology Criteria for Adverse Events version 4.03. Assessments will be at time of enrollment, weekly during RT, and at follow-up.

  5. Access Quality of Life

    Time frame: 1 year

    The FACT - Head & Neck questionnaire will be administered at time of enrollment, completion of RT, and at follow-up.

    The FACT - Head & Neck questionnaire is a battery of 39 questions across 5 domains, with each response given on a 0-4 scale, with 0 indicating no problem and 4 indicating severe problem. The average of responses within each domain will be calculated.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Acronym: RAD 1702

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Oct 23, 2017
Registry last updated
Jul 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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