Oropharyngeal Cancer, Squamous Cell Carcinoma to the Head and Neck
Conditions
Keywords
chemotherapy, radiation therapy
Brief 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 Department of Radiation Oncology at the University of Pennsylvania.
Interventions
DRUGLyrica 300 mg
Lyrica 300 mg per day
DRUGPlacebo
Sponsors
Abramson Cancer Center at Penn Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Average/Cumulative Opioid Dose | 18 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lyrica at 300 mg Per Day Lyrica 300 mg: Lyrica 300 mg per day | 9 |
| Placebo Placebo | 9 |
| Total | 18 |
Baseline characteristics
| Characteristic | Lyrica at 300 mg Per Day | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 3 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 6 Participants | 13 Participants |
| Age, Continuous | 57.3 years STANDARD_DEVIATION 14.1 | 56.3 years STANDARD_DEVIATION 10.5 | 56.5 years STANDARD_DEVIATION 11.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants | 9 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 8 Participants | 16 Participants |
| Region of Enrollment United States | 9 participants | 7 participants | 16 participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Male | 8 Participants | 8 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 9 |
| other Total, other adverse events | 0 / 9 | 0 / 9 |
| serious Total, serious adverse events | 0 / 9 | 2 / 11 |
Outcome results
Primary
Average/Cumulative Opioid Dose
Time frame: 18 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lyrica at 300 mg Per Day | Average/Cumulative Opioid Dose | 32.65306 mg | Standard Deviation 49.74759 |
| Placebo | Average/Cumulative Opioid Dose | 31.60714 mg | Standard Deviation 58.5934 |