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

Locally Advanced Head and Neck Cancer Clinical Trial

— RAD 1702  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03317730
• Other study ID #: IRB-300000574
• Status: Completed
• Phase: Early Phase 1
• Start date: May 1, 2018
• Est. completion date: November 17, 2020

Study information

• Verified date: July 2021
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: November 17, 2020
• Est. primary completion date: December 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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:

-

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Locally Advanced Head and Neck Cancer

Intervention

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.

Locations

Country	Name	City	State
United States	Hazelrig-Salter Radiation Oncology Center	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Determine Pain Control (at time of enrollment)	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.	1 year
Secondary	Determine Pain Control (weekly during RT)	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.	1 year
Secondary	Determine Pain Control (at follow-up)	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.	1 year
Secondary	Access Toxicity	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.	1 year
Secondary	Access Quality of Life	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.	1 year