Trials / Unknown
UnknownNCT03478605
Trial to Evaluate Efficacy of Olanzapine With Short-acting 5HT3 Inhibitors in Chemotherapy-induced Nausea & Vomiting (CINV) Prophylaxis
Phase II Randomized Trial to Evaluate Efficacy of Olanzapine With Short-acting 5HT3 Inhibitors in Chemotherapy-induced Nausea & Vomiting (CINV) Prophylaxis
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 130 (estimated)
- Sponsor
- Blokhin's Russian Cancer Research Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Olanzapine-containing regimens for CINV prophylaxis may provide even better protection than aprepitant-containing regimens.
Detailed description
Olanzapine-containing regimens for CINV provide high complete response (CR) rate in patients receiving high emetogenic chemotherapy. Olanzapine may be more effective than aprepitant in this setting but cheaper. However, there is no strong evidence supporting the advantages of olanzapine over aprepitant - and this is the reason why aprepitant is still the standard of care. Due to high cost aprepitant can be not affordable in low- and middle income countries; this compromises quality of life of cancer patients. On the other hand, recommended olanzapine-based regimen includes palonosetron, whose price is quite high as well and undesired sedation is a common side effect for olanzapine doses that currently recommended, these adverse events precludes wide use of olanzapine in oncology. Development of effective, tolerable and affordable regimen for CINV prophylaxis based on low-dose olanzapine and short-acting 5-HT3 inhibitors can improve quality of care for many cancer patients.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Olanzapine | Olanzapine 5 mg/day will be administered orally on days 0-4 of chemotherapy cycle (before bedtime) |
| DRUG | Aprepitant Pill | Aprepitant 125 mg orally will be administered on day 1 of chemotherapy cycle; 80 mg - on days 2 and 3. |
| DRUG | Ondansetron | Ondansetron 16 mg IV on day 1 of chemotherapy cycle (as standard component of antiemetic therapy) |
| DRUG | Dexamethasone | Dexamethasone 8 mg IV on day 1 of chemotherapy cycle; 8 mg IV or orally on days 2-3 (as standard component of antiemetic therapy) |
Timeline
- Start date
- 2018-05-25
- Primary completion
- 2019-05-25
- Completion
- 2019-06-01
- First posted
- 2018-03-27
- Last updated
- 2018-07-05
Locations
1 site across 1 country: Russia
Source: ClinicalTrials.gov record NCT03478605. Inclusion in this directory is not an endorsement.