Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm, Solid Neoplasm
Conditions
Brief summary
This phase I trial studies the side effects of Nozin in preventing respiratory viral infections in patients undergoing stem cell transplant. Nozin is a non-antibiotic, alcohol-based nasal sanitizer used in hospitals to prevent spread of bacterial infections and may also prevent community acquired respiratory virus infection in stem cell transplant recipients.
Detailed description
OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Beginning 7 days prior to transplant, patients receive Nozin via nasal single-use popswabs or single-use cotton tipped applicators and swab the inside of their nose two times daily (BID) up to 100 days after transplant. ARM II: Patients receive standard of care. After completion of study, patients are followed up every week for 6 weeks and then every alternate week until day 100.
Interventions
OTHERBest Practice
Receive standard of care
DRUGNozin
Given via nasal single-use popswabs or single-use cotton tipped applicators
Sponsors
Global Life Technologies Corp.
Fred Hutchinson Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Undergoing allogeneic hematopoietic transplant for malignant or non-malignant disease * English speaking * Capable of providing informed consent * Planned to receive follow-up at the transplant site for the first 100 days post transplantation * Subjects who the investigator believes can and will comply with the study protocol
Exclusion criteria
* Documented respiratory viral infection in the two weeks prior to enrollment * Current or planned use of any prophylactic antiviral therapy, antibody treatments, or other agents targeting the prevention of respiratory viruses (i.e. oseltamivir, ribavirin, amantadine) * Known allergy to study drug components (jojoba, orange oil, coconut oil, lauric acid, benzalkonium chloride, vitamin E) * Receiving oxygen supplementation at time of enrollment * Active mucositis at time of enrollment * Ongoing irritation or active infection of the squamous epithelial cell skin involving the nose or nasal vestibule * Daily use of nasal decontamination products or other nasal medications (e.g. nasal steroids) * Unable to complete study procedures (e.g. nasal swab self-testing)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tolerability of Nozin | Up to 100 days post-transplant | Will measure and describe reasons for dropout, defined as failure to complete the study to day 100 for any reason. Among participants in the study product arm, reasons for dropout will be classified as either directly related to the product or due to other reasons. Will estimate the proportion of participants who exit the study for reasons directly related to the study product with a precision of +/- 20% (95% confidence interval) to inform tolerability of study product for future studies. Will compare dropout for any reason between treatment arms using Fisher's exact test. |
| Incidence of adverse events (AEs) | Up to 100 days post-transplant | AEs will be graded in severity according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. All adverse events will be continually monitored by the study team and descriptively compared between study arms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of community acquired respiratory viruses (CARV) | Up to 100 days post-transplant | Will compare the cumulative incidence of CARV between study arms, counting death as a competing risk. Cox regression will be used to test for differences in the cause-specific hazard of CARV between study arms. |
| Frequency of respiratory viral symptoms | Up to 100 days post-transplant | Will use Poisson generalized estimating equation regression models to compare the frequency of respiratory viral symptoms between study arms |
| Number of respiratory viral panel tests | Up to 100 days post-transplant | Will compare the number of respiratory viral panel tests sent to the lab between study arms using Poisson regression with an offset for the number of days each participant was in the study. |
Countries
United States
Outcome results
None listed