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| ID | Type | Description | Link |
|---|---|---|---|
| HSC20210301H | Other Identifier | UT Health San Antonio |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dermaprazole | Experimental | 30 HNC patients who will be using Dermaprazole twice daily for 7 weeks |
|
| Aquaphor | Active Comparator | 15 HNC patients using Aquaphor, the current clinical standard of care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dermaprazole | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 15 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shraddha Dalwadi, MD | The University of Texas Health Science Center - Mays Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mays Cancer Center | San Antonio | Texas | 78229 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Participants receiving radiation therapy
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Number | Number of events | 15 months |
|
Baseline to 15 months
Adverse events considered to be possible or probably or definitely related to intervention. For purposes of this study, an adverse event is considered expected when the events are those related to systems within the radiation treatment field and include: infection, allergy, or short & long-term (greater than 6 month) skin changes.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Shraddha Dalwadi | University of Texas Health Science Center at San Antonio | 210-567-1203 | dalwadi@uthscsa.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 22, 2024 | May 16, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D064098 | Esomeprazole |
| D010577 | Petrolatum |
| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
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|
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| Aquaphor | Drug | 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. |
|
| Withdrawal by Subject |
|
| BG001 |
| 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 4 |
| 4 |
| EG001 | 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. | 0 | 2 | 0 | 2 | 2 | 2 |
| Anorexia | Gastrointestinal disorders | Non-systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Dehydration | General disorders | Non-systematic Assessment |
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| Dermatitis radiation | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Anosmia | Gastrointestinal disorders | Non-systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | Non-systematic Assessment |
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| Dysgeusia | Gastrointestinal disorders | Non-systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | Non-systematic Assessment |
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| Ear and Labyrinth disorders | Ear and labyrinth disorders | Non-systematic Assessment |
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| Fatigue | General disorders | Non-systematic Assessment |
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| Hoarsness | General disorders | Non-systematic Assessment |
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| Lymphedema | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Mucositis oral | Gastrointestinal disorders | Non-systematic Assessment |
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| Myelitis | Immune system disorders | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Pruritis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Oropharyngeal pain | Gastrointestinal disorders | Non-systematic Assessment |
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| Productive cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Sore throat | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Trismus | Gastrointestinal disorders | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
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| Weight loss | Gastrointestinal disorders | Non-systematic Assessment |
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| Lung infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Aspartate aminotransferase increased | Hepatobiliary disorders | Non-systematic Assessment |
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| Alanine aminotransferase increased | Hepatobiliary disorders | Non-systematic Assessment |
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| Allergic reaction | Immune system disorders | Non-systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Hypercalcemia | General disorders | Non-systematic Assessment |
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| Sleep apnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| White Blood Cell decrease | Blood and lymphatic system disorders | Non-systematic Assessment |
|
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| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006838 | Hydrocarbons |