Nausea Clinical Trial
— OlaCINVOfficial title:
Phase II Randomized Trial to Evaluate Efficacy of Olanzapine With Short-acting 5HT3 Inhibitors in Chemotherapy-induced Nausea & Vomiting (CINV) Prophylaxis
Olanzapine-containing regimens for CINV prophylaxis may provide even better protection than aprepitant-containing regimens.
Status | Recruiting |
Enrollment | 130 |
Est. completion date | June 1, 2019 |
Est. primary completion date | May 25, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. High-emetogenic chemotherapy (HEC) regimen (e.g., cisplatin =70 mg/m2 or doxorubicin =60 mg/m2 or carboplatin AUC=4). Patients that are prescribed less doses of mentioned agents are still allowed if another high-emetogenic drug will be administered (eg, doxorubicin plus cisplatin); 2. Administration of HEC component only in first day of the cycle; 3. No previous chemotherapy or radiotherapy; 4. No concomitant quinolone antibiotics administration; 5. ECOG PS =2; 6. No nausea and vomiting 24 hours before enrollment; 7. Adequate hepatic and renal function (eg, ALaT, ASaT =3 ULN, creatinine clearance =50 ml/minute). 8. No brain metastases, leptomeningeal carcinomatosis, and chronic diseases such as uncontrolled diabetes mellitus and chronic alcohol consumption. 9. Subject willing to participate in the trial and provided informed consent form. Exclusion Criteria: 1. Previous chemotherapy or radiotherapy; 2. Moderate- or low- emetogenic chemotherapy; 3. Multiday administration of HEC agents; 4. ECOG PS >2; 5. History of brain metastases, signs of symptoms of bowel obstruction; 6. Nausea and/or vomiting of any genesis 24 hours before enrollment; 7. Uncontrolled diabetes mellitus or other metabolic diseases; chronic alcohol consumption. 8. Diseases and conditions interfere with subject ability to swallow the drug and to take oral medication; 9. Concomitant therapy with olanzapine or other antipsychotic drugs; history of mental illness; 10. Concomitant therapy with quinolone antibiotics; 11. Contraindications for olanzapine or aprepitant administration; 12. Intraperitoneal or intrapleural administration of HEC drugs; 13. Inadequate hepatic and/or renal function. |
Country | Name | City | State |
---|---|---|---|
Russian Federation | N.N. Blokhin Cancer Research Center | Moscow |
Lead Sponsor | Collaborator |
---|---|
Blokhin's Russian Cancer Research Center | RUSSCO/RakFond |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Nausea control | Complete control of nausea (ie, no nausea) in overall treatment period (0-120 hours after chemotherapy). | 0-120 hours after chemotherapy | |
Secondary | Complete Response Rate in Overall Treatment Period | Complete response rate (ie, no vomiting, no use of rescue medication) in 0-120 hours after chemotherapy | 0-120 hours after chemotherapy | |
Secondary | Rate of undesired sedation | Rate of undesired sedation 0-120 hours after chemotherapy | 0-120 hours after chemotherapy | |
Secondary | Complete Response Rate in Acute Treatment Period | Complete response rate (ie, no vomiting, no use of rescue medication) in 0-24 hours after chemotherapy | 0-24 hours after chemotherapy | |
Secondary | Complete Response Rate in Delayed Treatment Period | Complete response rate (ie, no vomiting, no use of rescue medication) in 24-120 hours after chemotherapy | 24-120 hours after chemotherapy |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT01649258 -
Fosaprepitant Dimeglumine and Granisetron Transdermal System in Preventing Nausea and Vomiting in Patients With Breast Cancer Undergoing Chemotherapy
|
Phase 1 | |
Completed |
NCT02939287 -
Aprepitant- and Olanzapine- Containing Anti-emetic Regimens With High Dose Melphalan
|
Phase 3 | |
Not yet recruiting |
NCT06464926 -
Chronic Nausea and Vomiting in Patients With Normal Gastric Emptying Using the Enterra® Therapy System (NAVIGATE)
|
N/A | |
Not yet recruiting |
NCT06055192 -
Prevalence and Burden of Nausea and Vomiting in Pregnant Women in Switzerland: Survey Purity 2022
|
||
Recruiting |
NCT04091789 -
Sublingual Tablets With Cannabinoid Combinations for the Treatment of Dysmenorrhea
|
Phase 2 | |
Completed |
NCT02462811 -
A Double-Blind, Randomized, Active- and Placebo-Controlled, Multiple-Dose Multi-Center Phase 3 Study of the Safety and Efficacy of CL-108 in the Treatment of Moderate to Severe Acute Pain and Opioid-Induced Nausea and Vomiting (OINV)
|
Phase 3 | |
Completed |
NCT01007500 -
Effect of Dexamethasone Combined With Ondansetron on Postoperative Nausea and Vomiting in Patients With Patient-controlled Analgesia After Video-assisted Thoracoscopic Surgery
|
Phase 4 | |
Recruiting |
NCT00528554 -
Laser Acupuncture Against Nausea in Children
|
N/A | |
Completed |
NCT00537875 -
Evaluation of the Effect of Zingiber Officinalis on Nausea and Vomiting in Patients Receiving Cisplatin Based Regimens
|
N/A | |
Completed |
NCT00394966 -
A Multicenter, Randomized, Controlled Trial of SCH 619734 for the Treatment of Chemotherapy-Induced Nausea and Vomiting (Study P04351AM2)(COMPLETED)
|
Phase 2 | |
Completed |
NCT00947128 -
To Demonstrate the Relative Bioavailability Study of Ondansetron HCl 24 mg Tablets Under Non-Fasting Conditions
|
Phase 1 | |
Completed |
NCT00946387 -
To Demonstrate the Relative Bioavailability Study of Ondansetron HCl 24 mg Tablets Under Fasting Conditions
|
Phase 1 | |
Recruiting |
NCT05433636 -
Mindful Waiting Room
|
N/A | |
Not yet recruiting |
NCT04827108 -
Psychometric Properties of the Chinese Version of PeNAT
|
||
Not yet recruiting |
NCT04853303 -
VR to Improve CINV, Sleep and Pain Among Children With Cancer in HK
|
N/A | |
Terminated |
NCT04247100 -
A Study of Randomized Sham-control Auricular TENS Unit Stimulation in Pediatric Functional Gastrointestinal Disorders
|
N/A | |
Recruiting |
NCT04181346 -
Pregabalin for the Prevention of Chemotherapy Induced Nausea and Vomiting
|
Phase 2 | |
Recruiting |
NCT03679182 -
Efficacy and Safety of Olanzapine for the Treatment of Nausea and Vomiting in Palliative Cancer Care
|
Phase 2 | |
Completed |
NCT02618343 -
EMS Use of Isopropyl Alcohol Aromatherapy Versus Ondansetron
|
N/A | |
Terminated |
NCT01405924 -
Fosaprepitant (MK-0517, EMEND® IV) In Salvage Treatment of Chemotherapy-Induced Vomiting (MK-0517-030)
|
Phase 2 |