Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a single-site, open-label, randomized pilot feasibility study conducted at The Ottawa Hospital Cancer Centre. A total of 10 participants will be randomized 1:1 to either the experimental or control arm.
The purpose of this study is to evaluate recruitment capability, intervention adherence, data completeness, and safety prior to consideration of a potential future multi-centre randomized trial.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Active Comparator |
|
|
| Group 2 | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Netupitant/Palonosetron Hydrochloride | Drug | 300mg/0.5mg combination pill taken once daily by mouth on the first and third day of chemotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of study | To measure the feasibility of the study, the researchers will collect the recruitment rate, the consent rate among eligible patients, the completion of symptom and quality-of-life assessments, the adherence to protocol, the frequency of protocol deviations and safety events. | Through study completion, up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response (CR) | To evaluate the CR after Cycle 1 | After Cycle 1 (Each cycle is 7 days) |
| Early Complete Response, late Complete Response and total control | To evaluate the response at the end of the study |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dominick Bossé, M.D. | Contact | 1-613-737-7700 | 70166 | dbosse@toh.ca |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ottawa Hospital Cancer Centre | Ottawa | Ontario | K1H 8L6 | Canada |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Ondansetron (Control) | Drug | 8mg taken twice daily by mouth for 5 days |
|
| Aprepitant | Drug | Daily by mouth on the first (125mg), third (80mg), and fifth (80mg) day |
|
| Dexamethasone | Drug | Daily by mouth for 7 days (12mg on the first day, 8mg on subsequent days) |
|
| Olanzapine | Drug | 5mg taken at night by mouth for 7 days |
|
| 1 year |
| Review toxicities | Describe patient-reported toxicities using PRO-CTCAE | 1 year |
| Quality of Life outcomes | Describe the quality of life outcomes using the Functional Living Index Emesis (FLIE) | 1 year |
| ID | Term |
|---|---|
| D009373 | Neoplasms, Germ Cell and Embryonal |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| C508854 | netupitant |
| D000077924 | Palonosetron |
| D017294 | Ondansetron |
| D000077608 | Aprepitant |
| D003907 | Dexamethasone |
| D000077152 | Olanzapine |
| ID | Term |
|---|---|
| D011812 | Quinuclidines |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006571 | Heterocyclic Compounds |
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D002227 | Carbazoles |
| D007211 | Indoles |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D009025 | Morpholines |
| D010078 | Oxazines |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
Not provided
Not provided