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Pilot Trial of Microsphere Oxycodone (Xtampza ER) for Pain Management in Patients Receiving Radiotherapy for Locally Advanced Head and Neck Cancer (RAD 1702)

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ClinicalTrials.gov Identifier: NCT03317730
Recruitment Status : Recruiting
First Posted : October 23, 2017
Last Update Posted : May 22, 2018
Sponsor:
Information provided by (Responsible Party):
Andrew McDonald, University of Alabama at Birmingham

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

Condition or disease Intervention/treatment Phase
Locally Advanced Head and Neck Cancer Drug: Xtampza ER Early Phase 1

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Trial of Microsphere Oxycodone (Xtampza ER) for Pain Management in Patients Receiving Radiotherapy for Locally Advanced Head and Neck Cancer
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: RT + Xtampza ER
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
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 Outcome Measures :
  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 Outcome Measures :
  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.




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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03317730


Contacts
Contact: Valerie P Powell 205-975-9316 vpowell@uabmc.edu
Contact: Andrew M McDonald, MD 205-975-0872 ammcdonald@uabmc.edu

Locations
United States, Alabama
Hazelrig-Salter Radiation Oncology Center Recruiting
Birmingham, Alabama, United States, 35233
Contact: Andrew M McDonald, MD    205-976-5669    ammcdonald@uabmc.edu   
Contact: Katherine Reeves, RN, MPH    2056-975-2880    katherinewood@uabmc.edu   
Sponsors and Collaborators
University of Alabama at Birmingham

Responsible Party: Andrew McDonald, Assistant Professor - Department of Radiation Oncology, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03317730     History of Changes
Other Study ID Numbers: IRB-300000574
First Posted: October 23, 2017    Key Record Dates
Last Update Posted: May 22, 2018
Last Verified: May 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Andrew McDonald, University of Alabama at Birmingham:
Xtampza ER
LAHNC
Head and neck cancer
Pain management

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Oxycodone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents