Oropharyngeal CancerNCT02277548
A Pilot Study at a Single-Institution of Pregabalin in the Management of Mucositis Pain in Patients Undergoing Chemoradiation Therapy to the Head and Neck.
A study testing Lyrica 300 mg in people with Oropharyngeal Cancer and Squamous Cell Carcinoma to the Head and Neck, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
To assess the efficacy of pregabalin in the management of mucositis pain in patients receiving radiotherapy to the head and neck. Eligible study subjects will be enrolled among those being treated for oropharyngeal cancer with definitive chemotherapy and radiation therapy (photons) to the head and neck in the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oropharyngeal Cancer, Squamous Cell Carcinoma to the Head and Neck
- What is being tested?
- Lyrica 300 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Apr 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients being treated for oropharyngeal cancer with undergoing concurrent chemotherapy and radiation therapy (photons) for a histological diagnosis of squamous cell carcinoma to the head and neck at the University of Pennsylvania
- Age at least 18 years old
- Treatment entails significant risk for symptomatic mucositis likely to require opioid analgesia, as per the discretion of treating physician/NP
- Subjects are capable of giving informed consent
Who cannot join
- Patients anticipated to receive radiation therapy with Protons
- History of hypersensitivity to pregabalin or gabapentin
- History of seizure or currently taking anti-epileptic medication
- Creatinine clearance of less than 30 mL/min by Cockcroft-Gault estimate
- Has another painful condition requiring chronic use of opioid analgesic, gabapentin, or pregabalin
- History of serious mood disorder or attempted suicide as determined by patients history and physical and by using theDepression Screening
Show all 11Show fewer
- Subjects with a score of greater than 10 or those answering #5 with scores greater than a "0" will be deemed ineligible to be enrolled on study
- History of angioedema
- New York Heart Association class III or IV heart failure
- Platelets of less than 150 mg/dL or history of thrombocytopenia
- The patient has any uncontrolled intercurrent illness including but not limited to psychiatric illness/social situations that would limit compliance or interfere with their ability to participate
Trial locations and contacts
1 site in 1 country.
United States1 site
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
To assess the efficacy of pregabalin in the management of mucositis pain in patients receiving radiotherapy to the head and neck. Eligible study subjects will be enrolled among those being treated for oropharyngeal cancer with definitive chemotherapy and radiation therapy (photons) to the head and neck in the Department of Radiation Oncology at the University of Pennsylvania.
- Being tested
- Lyrica 300 mg, Placebo
- Keywords
- chemotherapy, radiation therapy
- Medical subject headings
- Oropharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lyrica 300 mgDrug
Lyrica 300 mg per day
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Lyrica at 300 mg per day | Experimental | Not described Receives: Drug: Lyrica 300 mg |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average/Cumulative Opioid Dose
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2014 (estimated)
- Study startMay 2014
- Primary completionApr 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Oropharyngeal CancerStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erin McMenamin, MSN, CRNP, Principal investigator, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02277548
- Sponsor's protocol ID
- UPCC 43313
- Status last verified
- Nov 2019
- First submitted
- 27 Oct 2014
- Last updated
- 21 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study at a Single-Institution of Pregabalin in the Management of Mucositis Pain in Patients Undergoing Chemoradiation Therapy to the Head and Neck.
- ClinicalTrials.gov ID
- NCT02277548
- Acronym / sponsor ID
- UPCC 43313
- Keywords
- chemotherapy, radiation therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 29 Oct 2014 (estimated)
- Results
- Posted 21 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the efficacy of pregabalin in the management of mucositis pain in patients receiving radiotherapy to the head and neck. Eligible study subjects will be enrolled among those being treated for oropharyngeal cancer with definitive chemotherapy and radiation therapy (photons) to the head and neck in the Department of Radiation Oncology at the University of Pennsylvania.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lyrica at 300 mg per day | Experimental | Drug: Lyrica 300 mg |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients being treated for oropharyngeal cancer with undergoing concurrent chemotherapy and radiation therapy (photons) for a histological diagnosis of squamous cell carcinoma to the head and neck at the University of Pennsylvania
- Age at least 18 years old
- Treatment entails significant risk for symptomatic mucositis likely to require opioid analgesia, as per the discretion of treating physician/NP
- Subjects are capable of giving informed consent
Key exclusion criteria (11 listed)
- Patients anticipated to receive radiation therapy with Protons
- History of hypersensitivity to pregabalin or gabapentin
- History of seizure or currently taking anti-epileptic medication
- Creatinine clearance of less than 30 mL/min by Cockcroft-Gault estimate
- Has another painful condition requiring chronic use of opioid analgesic, gabapentin, or pregabalin
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 |
|---|---|---|
| Lyrica 300 mgLyrica 300 mg per day | Drug | Lyrica at 300 mg per day |
| Placebo | Drug | Placebo |
Primary outcome
Average/Cumulative Opioid Dose
Time frame: 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Erin McMenamin, MSN, CRNP principal investigator
Abramson Cancer Center at Penn Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lyrica 300 mg in people with Oropharyngeal Cancer and Squamous Cell Carcinoma to the Head and Neck, run by Abramson Cancer Center at Penn Medicine 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 4 inclusion and 11 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 21 Nov 2019. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Average/Cumulative Opioid Dose (time frame: 18 months). 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 21 Nov 2019.