Cancer of the Head and Neck
Conditions
Brief summary
In this study, the study team seek to conduct a pilot clinical study to evaluate the safety and efficacy of a reformulated proton pump inhibitor (PPI) cream (Dermaprazole) in definitive head and neck cancer (HNC) patients.
Interventions
DRUGDermaprazole
Patients will be managed with twice daily prophylactic use of the proposed intervention (Dermaprazole) topical cream for radiation dermatitis. The amount of cream will be 2cc per application and will be measured in pre-filled capped syringes for every application.
DRUGAquaphor
Patients will be managed with twice daily prophylactic use of Aquaphor. The amount of Aquaphor will be 2cc per application and will be measured in pre-filled capped syringes for every application.
Sponsors
The University of Texas Health Science Center at San Antonio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with head and neck malignancy (including radiation therapy to primary head cancers of any histology and/or neck lymphatics, excluding brain malignancies) * Biopsy proven diagnosis of head and neck malignancy * Planned to receive definitive chemoradiation of at least 66Gy * Age 18 years or older * Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2 * Written Informed Consent * History and Physical within 12 weeks of enrollment
Exclusion criteria
* Prior head and neck radiotherapy * Neoadjuvant chemotherapy * Any serious medical condition or illness that would preclude the safe administration of the trial treatment including, but not limited to, active infection, symptomatic heart failure, unstable angina, psychiatric illness or social situations that would limit compliance with treatment * Currently taking proton pump inhibitors. Eligible if discontinues with physician approval. * Lack of concurrent chemotherapy * Open wound at time of simulation * Known autoimmune, connective tissue, or skin disorder; or other theoretical radiosensitivity to include bullous pemphigoid, dermatomyositis, lupus of the skin and scleroderma
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rates of Clinically Significant Radiation Dermatitis as Defined as NCI CTCAE Version 5 Grade 2 or Higher | 15 months | Number of radiation dermatitis adverse events defined by the NCI CTCAE version 5 that are graded as 2 or higher |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dermaprazole HNC patients who will be using Dermaprazole twice daily for 7 weeks
Dermaprazole: Patients will be managed with twice daily prophylactic use of the proposed intervention (Dermaprazole) topical cream for radiation dermatitis. The amount of cream will be 2cc per application and will be measured in pre-filled capped syringes for every application. | 4 |
| Aquaphor HNC patients using Aquaphor, the current clinical standard of care
Aquaphor: Patients will be managed with twice daily prophylactic use of Aquaphor. The amount of Aquaphor will be 2cc per application and will be measured in pre-filled capped syringes for every application. | 2 |
| Total | 6 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Physician Decision | 2 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Dermaprazole | Aquaphor | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 1 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 2 Participants | 6 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 | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 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 | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 2 Participants | 2 Participants | 4 Participants |
| Region of Enrollment United States | 4 participants | 2 participants | 6 participants |
| Sex: Female, Male Female | 2 Participants | 0 Participants | 2 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 2 |
| other Total, other adverse events | 4 / 4 | 2 / 2 |
| serious Total, serious adverse events | 0 / 4 | 0 / 2 |
Outcome results
Primary
Rates of Clinically Significant Radiation Dermatitis as Defined as NCI CTCAE Version 5 Grade 2 or Higher
Number of radiation dermatitis adverse events defined by the NCI CTCAE version 5 that are graded as 2 or higher
Time frame: 15 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dermaprazole | Rates of Clinically Significant Radiation Dermatitis as Defined as NCI CTCAE Version 5 Grade 2 or Higher | 3 Number of events |
| Aquaphor | Rates of Clinically Significant Radiation Dermatitis as Defined as NCI CTCAE Version 5 Grade 2 or Higher | 1 Number of events |