Locally Advanced Head and Neck CancerEarly Phase 1RAD 1702NCT03317730
Pilot Trial of Microsphere Oxycodone (Xtampza ER) for Pain Management in Patients Receiving Radiotherapy for Locally Advanced Head and Neck Cancer
A Early Phase 1 study testing Xtampza ER in people with Locally Advanced Head and Neck Cancer, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
To confirm the feasibility of studying Xtampza ER during radiotherapy (RT) for LAHNC as part of a prospective clinical trial. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Locally Advanced Head and Neck Cancer
- What is being tested?
- Xtampza ER
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2018to 17 Nov 2020
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Hazelrig-Salter Radiation Oncology Center
Birmingham, Alabama, 35233
About this study
To confirm the feasibility of studying Xtampza ER during radiotherapy (RT) for LAHNC as part of a prospective clinical trial.
Read the 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.
- Conditions
- Locally Advanced Head and Neck Cancer
- Being tested
- Xtampza ER
- Keywords
- Xtampza ER, LAHNC, Head and neck cancer, Pain management
- Medical subject headings
- Head and Neck Neoplasms, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xtampza ERDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Xtampza ER |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (5)
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.
Measured: 1 year
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.
Measured: 1 year
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.
Measured: 1 year
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.
Measured: 1 year
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2017
- Study start1 May 2018
- Primary completion4 Dec 2019
- Study completion17 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew McDonald, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03317730
- Sponsor's protocol ID
- IRB-300000574
- Acronym
- RAD 1702
- Status last verified
- Jul 2021
- First submitted
- 11 Oct 2017
- Last updated
- 20 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial of Microsphere Oxycodone (Xtampza ER) for Pain Management in Patients Receiving Radiotherapy for Locally Advanced Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT03317730
- Acronym / sponsor ID
- RAD 1702 / IRB-300000574
- Conditions
- Locally Advanced Head and Neck Cancer
- Keywords
- Xtampza ER, LAHNC, Head and neck cancer, Pain management
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 4 Dec 2019 (actual)
- Study completion
- 17 Nov 2020 (actual)
- First posted
- 23 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To confirm the feasibility of studying Xtampza ER during radiotherapy (RT) for LAHNC as part of a prospective clinical trial.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RT + Xtampza ER | Experimental | Drug: Xtampza ERThis 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xtampza ERXtampza 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. | Drug | RT + Xtampza ER |
Primary outcome
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.
5 secondary outcomes
Determine Pain Control (at time of enrollment)
Time frame: 1 year
Determine Pain Control (weekly during RT)
Time frame: 1 year
Determine Pain Control (at follow-up)
Time frame: 1 year
Access Toxicity
Time frame: 1 year
Access Quality of Life
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Xtampza ER in people with Locally Advanced Head and Neck Cancer, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Xtampza ER during radiotherapy (RT) for locally advanced head and neck cancer (LAHNC). (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2021.