Preventing nausea and vomiting in chemotherapy patients
Akynzeo or Olanzapine for Patients Who Experience Breakthrough CINV in Patient Receiving Moderately or Highly Emetogenic Chemotherapy After First Cycle of Chemotherapy
PHASE2 · Simon Williamson Clinic · NCT06065722
This study is testing if a new combination medication can better prevent nausea and vomiting in cancer patients who have already experienced these side effects from chemotherapy.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Simon Williamson Clinic (industry) |
| Drugs / interventions | CHEMOTHERAPY, radiation |
| Locations | 1 site (Mount Olive, Alabama) |
| Trial ID | NCT06065722 on ClinicalTrials.gov |
What this trial studies
This study aims to improve the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients undergoing moderately or highly emetogenic chemotherapy who experienced breakthrough CINV after their first treatment cycle. It will evaluate the effectiveness of Akynzeo, a combination of a neurokinin-1 receptor antagonist and a 5-HT3 receptor antagonist, in controlling CINV. The study will focus on patient characteristics that may increase the risk of CINV and will follow established guidelines to optimize prophylaxis. By addressing this issue, the study seeks to enhance patients' quality of life and treatment adherence.
Who should consider this trial
Good fit: Ideal candidates are chemotherapy-naive patients with lung or breast cancer receiving moderately or highly emetogenic chemotherapy.
Not a fit: Patients who have previously undergone chemotherapy or those experiencing nausea or vomiting within 24 hours prior to study entry may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of CINV, improving the quality of life for patients undergoing chemotherapy.
How similar studies have performed: Previous studies have shown that combining NK-1 receptor antagonists with other antiemetics can improve CINV control, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * CHEMOTHERAPY NAIIVE * patient receiving moderately or highly emetogenic chemotherapy * lung cancer * breast cancer Exclusion Criteria: * PRIOR CHEMOTHERAPY for any cancer * nausea or vomiting 24 hours prior to study entry
Where this trial is running
Mount Olive, Alabama
- Rudolph M Navari — Mount Olive, Alabama, United States (RECRUITING)
Study contacts
- Study coordinator: Rudolph M Navari
- Email: rmnavari@gmail.com
- Phone: 5742618385
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Chemotherapy Induced Nausea and Vomiting, chemotherapy induced nausea and vomiting, NK-1, olanzapine