[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"nausea-and-vomiting-chemotherapy-induced\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:nausea-and-vomiting-chemotherapy-induced":90},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,43,78],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":25,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100621770","medical-cannabis-observational-study-for-antiemetic-intervention-in-chemotherapy-100621770",false,"NCT07374939","Medical Cannabis Observational Study for Antiemetic Intervention in Chemotherapy","MOSAIC","Inclusion Criteria:\n\n* Have a diagnosis of cancer with no previous chemotherapy treatments (aside from current treatment)\n* Be scheduled to receive treatment with a chemotherapeutic agent that is classified by the National Comprehensive Cancer Network (NCCN) as having a high emetogenic potential (\\>90% incidence) or moderate emetogenic potential (30-90% incidence).\n* Must be scheduled for a minimum of 3 additional chemotherapy cycles at the time of enrollment.\n* Chemotherapy agents may be given intravenously or orally.\n* Chemotherapy cycles must be at least two weeks apart.\n* For the purposes of this study, Day 1 is defined as the day of chemotherapy administration.\n* Chemotherapy may be for adjuvant, neoadjuvant, curative, or palliative intent.\n* Highly emetogenic - common types of chemotherapy\n\n  * AC combination defined as any chemotherapy regimen that contains an anthracycline and cyclophosphamide\n  * Carboplatin AUC ≥4\n  * Carmustine \\>250 mg\u002Fm2\n  * Cisplatin\n  * Cyclophosphamide \\>1,500 mg\u002Fm2\n  * Dacarbazine\n  * Doxorubicin ≥60 mg\u002Fm2\n  * Epirubicin \\>90 mg\u002Fm2\n  * Ifosfamide ≥2 g\u002Fm2 per dose\n  * Mechlorethamine\n  * Streptozocin\n* Moderately emetogenic - common types of chemotherapy:\n\n  * Aldesleukin \\>12-15 million IU\u002Fm2\n  * Amifostine \\>300 mg\u002Fm2\n  * Arsenic trioxide\n  * Azacitidine\n  * Bendamustine\n  * Busulfan\n  * Carboplatin AUC \\\u003C4\n  * Carmustined ≤250 mg\u002Fm2\n  * Clofarabine\n  * Cyclophosphamide ≤1500 mg\u002Fm2\n  * Cytarabine \\>200 mg\u002Fm2\n  * Dactinomycin\n  * Daunorubicin\n  * Dual-drug liposomal encapsulation of cytarabine and daunorubicin\n  * Dinutuximab\n  * Doxorubicind \\\u003C60 mg\u002Fm2\n  * Epirubicind ≤90 mg\u002Fm2\n  * Idarubicin\n  * Ifosfamided \\\u003C2 g\u002Fm2 per dose\n  * Interferon alfa ≥10 million IU\u002Fm2\n  * Irinotecan\n  * Irinotecan (liposomal)\n  * Melphalan\n  * Methotrexated ≥250 mg\u002Fm2\n  * Oxaliplatin\n  * Temozolomide\n  * Trabectedin\n* Be willing to commit to the suggested medication dosing and delivery method, completing evaluation instruments, and attending all study visits.\n* Be able to understand English (all assessment instruments are in English).\n* Be 21 years of age or older.\n* Give informed consent.\n* Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control, or abstinence) for the duration of the study. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately.\n\nExclusion Criteria:\n\n* Participants must not:\n* Use of any THC-containing cannabis products within 30 days prior to enrollment, verified by participant self-report.\n\nAllowable: Use of hemp-derived CBD products containing \\\u003C 0.3 % THC is permitted, consistent with the 2018 Agriculture Improvement Act (federal definition of hemp). Use of CBD products will be documented in baseline case report forms.\n\n* Have any allergies to cannabis or contraindication for cannabis.\n* Have an active or recent (\\\u003C 6 months) substance use disorder, as determined by medical history.\n* Have recently quit smoking (\\\u003C 6 months) or are actively engaged in a smoking-cessation program.\n* Have a history of severe anxiety or paranoia on prior exposure to cannabis.\n* Have a previous diagnosis of bipolar disorder or schizophrenia.\n* Be pregnant or nursing.\n* Have had a prior stroke.\n* Have moderate or severe chronic obstructive pulmonary disease (COPD), defined as FEV₁ \\\u003C 50 % predicted or current use of home supplemental oxygen.","ALL","21 Years",{"count":19,"type":20},50,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to evaluate the associations between patient-directed medical cannabis use and chemotherapy-induced nausea and vomiting (CINV), as well as other treatment-related symptoms, among patients receiving chemotherapy that is known to cause nausea. The main questions it aims to answer are:\n\n* Is patient-directed medical cannabis use associated with reduced nausea severity during chemotherapy treatment?\n* Is-patient directed medical cannabis use associated with improved CINV control?\n* Is patient directed medical cannabis use associated with improved appetite during chemotherapy treatment?\n* Is patient-medical cannabis use associated with reduced treatment-related side effects, such as fatigue, sleep disturbances, general pain, and peripheral neuropathic pain?\n\nResearchers will compare participants who report using medical cannabis with participants who do not report using medical cannabis to determine whether differences exist in nausea, CINV outcomes, and other treatment-related symptoms.\n\nParticipants will be followed over the course of 3 chemotherapy cycles, and asked to complete questionnaires, nausea diaries, and partake in a blood sample collection. Study participation can last from 6 - 12 weeks, depending on their prescribed chemotherapy cycle frequency.",[24],"Nausea and Vomiting Chemotherapy-Induced",[26,27,28,29],"medical cannabis","chemotherapy-induced nausea and vomiting","nausea","nausea and vomiting","NOT_YET_RECRUITING","2026-06-04",{"date":33,"type":34},"2026-06-09","ACTUAL",{"date":36,"type":20},"2026-09-01",{"date":38,"type":20},"2028-03-01",{"name":40,"class":41},"University of Rochester","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":77},"100585582","phase-2-study-with-iv-nepa-fosnetupitantpalonosetron-for-the-prevention-of-chemotherapy-induced-nausea-and-vomiting-in-paediatric-cancer-patients-undergoing-highly-emetogenic-chemotherapy-hec-100585582","NCT06904235","Study With IV NEPA (Fosnetupitant\u002FPalonosetron) for the Prevention of Chemotherapy-induced Nausea and Vomiting in Paediatric Cancer Patients Undergoing Highly Emetogenic Chemotherapy (HEC)","A Multicentre, Multinational, Pharmacokinetic, Safety, and Efficacy Study With IV NEPA (Fosnetupitant\u002FPalonosetron) for the Prevention of Chemotherapy-induced Nausea and Vomiting in Paediatric Cancer Patients Undergoing Highly Emetogenic Chemotherapy (HEC). A 2-part Study With Phase 2, Open-label, Randomised, Single-dose IV NEPA vs Fosaprepitant\u002FOndansetron in Single-day HEC and Repeated-dose IV NEPA in Multi-day HEC (Part I, Single Cycle) and With Phase 3, Double-blind, Randomised, Repeated-dose IV NEPA vs Fosaprepitant\u002FOndansetron in Multi-day HEC (Part II, Repeated Cycles)","Inclusion Criteria:\n\nThe following inclusion criteria must be checked prior to study inclusion:\n\n1. Signed written Informed Consent Form (ICF) by parent(s)\u002Flegal guardian of the paediatric patient in compliance with the local laws and regulations. In addition, the signed children's Assent Form according to local requirements.\n2. Male or female in- or out-patient from 0 months (newborns) to \\\u003C18 years on the date of enrolment (Day 1).\n3. Cohort 1: Patient \\\u003C 6 months weighing at least 4 kg or patient ≥ 6 months weighing at least 6 kg.\n\n   Cohort 2: Patient weighing at least 4 kg.\n4. Patient with a predicted life expectancy ≥3 months according to Investigator's opinion.\n5. Patient naïve or non-naïve to chemotherapy, with histologically and\u002For cytologically (or imaging in the case of brain tumours and nephroblastomas) confirmed malignant disease.\n6. Cohort 1: Patient scheduled and eligible to receive at least 1 cycle of single-day HEC.\n\n   Cohort 2: Patient scheduled and eligible to receive at least 1 cycle of multi-day HEC.\n\n   (For the level of emetogenicity of the chemotherapeutic agents, refer to the POGO January 2021 guideline).\n7. For patients aged ≥10 years: Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤2.\n8. For patient with known hepatic impairment: the patient may be enrolled provided the serum ALT and AST are ≤2.5 ULN, the total bilirubin is ≤1.5 ULN, and in the Investigator's opinion the impairment is not expected to jeopardize the patient's safety during the study.\n9. For patient with known renal impairment: the patient may be enrolled provided the estimated glomerular filtration rate (eGFR) is ≥70 mL\u002Fmin\u002F1.73m2 (≥50 mL\u002Fmin\u002F1.73m2 for children \\\u003C3 months old) (the eGFR should be calculated using the modified Schwartz equation) and in the Investigator's opinion the impairment is not expected to jeopardize the patient's safety during the study.\n10. For patient with known history or predisposition to cardiac abnormalities: as per the Investigator's opinion, the history\u002Fpredisposition should not jeopardize patient's safety during the study.\n11. Patient with non-clinically significant abnormal laboratory values or with clinically relevant abnormal laboratory values may be enrolled if in the Investigator's opinion the patient's safety is not expected to be jeopardized.\n12. Female patient shall: a) not have attained menarche yet or b) have attained menarche and have a negative serum pregnancy test at the Screening Visit and a negative urine pregnancy test at Day 1.\n13. Male or female fertile patient using reliable contraceptive measures. Such measures, for patient and sexual partner, include: implants, injectables, combined oral contraceptives, intrauterine devices, vasectomized\u002Fsterilized partner, use of a double barrier method, or sexual abstinence. The patient and his\u002Fher parent(s)\u002Flegal guardian must be counselled on the importance of avoiding pregnancy before and during the study.\n\nExclusion Criteria:\n\n1. The patient and\u002For parent(s)\u002Flegal guardian are expected by the Investigator to be non compliant with the study procedures.\n2. Patient has received or is scheduled to receive total body irradiation; total nodal irradiation; upper abdomen radiotherapy; half or upper body irradiation; or radiotherapy of the cranium, craniospinal regions, head and neck, lower thorax region, or the pelvis within 1 week prior to study entry (Day 1) or within 120 h after start of chemotherapy on Day 1 (Cohort 1 patients) or within 168 h (for Cohort 2 patients receiving the last IV NEPA on Day 3) or 216 h (for Cohort 2 patients receiving the last IV NEPA on Day 5) from start of chemotherapy on Day 1.\n3. Known history of allergy to any component of the study treatments or other contraindications to any NK1-RAs or 5-HT3-RAs.\n4. Active infection.\n5. Any illness or condition that, in the opinion of the Investigator, may pose unwarranted risks in administering the investigational product to the patient.\n6. Uncontrolled medical condition (e.g., uncontrolled insulin-dependent diabetes mellitus).\n7. Patient experiencing ongoing vomiting from any organic aetiology (including patients with history of gastric outlet obstruction or intestinal obstruction due to adhesions or volvulus), or patient with hydrocephalus.\n8. Patient who experienced any vomiting, retching, or nausea within 24 h prior to the administration of the study treatment on Day 1 (Note: functional vomiting for infants, which is normally seen during the first 3 months of life, is not to be considered as vomiting).\n9. Patient who received any drug with potential antiemetic effect within 24 h prior to administration of study treatment on Day 1, including but not limited to the following:\n\n   * NK1-RAs (e.g., (fos)aprepitant or any other drug of this class)\n   * 5-HT3-RAs (e.g., ondansetron, granisetron, dolasetron, tropisetron, ramosetron)\n   * Benzamides (e.g., metoclopramide, alizapride)\n   * Phenothiazines (e.g., prochlorperazine, promethazine, perphenazine, fluphenazine, chlorpromazine, thiethylperazine)\n   * Benzodiazepines initiated 48 h prior to study treatment administration on Day 1 or expected to be administered within the efficacy assessment period, except for single doses of midazolam, temazepam, or triazolam\n   * Butyrophenones (e.g., droperidol, haloperidol)\n   * Anticholinergics (e.g., scopolamine, except the inhaled anticholinergics for respiratory disorders e.g., ipratropium bromide)\n   * Antihistamines (e.g., diphenhydramine, cyclizine, hydroxyzine, chlorphenhyramine, dimenhydrinate, meclizine)\n   * Domperidone\n   * Mirtazapine\n   * Olanzapine\n   * Prescribed cannabinoids (e.g., tetrahydrocannabinol, nabilone)\n   * Over-the-counter (OTC) antiemetics, OTC cold medications, or OTC allergy medications\n   * Herbal preparations containing ephedra or ginger\n10. Patient who received palonosetron within 1 week prior to administration of study treatment on Day 1.\n11. Patient receiving systemic corticosteroid therapy above 0.14mg\u002Fkg or \\>10 mg of prednisone daily or equivalent.\n\n    Exception:\n\n    Dexamethasone for the prevention of CINV is permitted in association with the study treatment (Test Treatment and Reference Treatment) as per standard of care and applicable guidelines, provided its dosage is reduced by 50% in consideration of known interactions with various NK1 RAs, including fosaprepitant and fosnetupitant.\n12. Patient aged \\\u003C6 years who received any investigational drug (defined as a medication with no marketing authorization granted for any age or indication) within 90 days prior to Day 1, or patient aged ≥6 years who received any investigational drug within 30 days prior to Day 1, or patient any age who is expected to receive investigational drugs prior to study completion.\n13. Intake of alcohol, food, or beverages (e.g., grapefruit, cranberry, pomegranate, and aloe vera juices; German chamomile) known to interfere with CYP3A4 or CYP2D6 metabolic enzymes within 1 week prior to Day 1 and during the overall study period.\n14. Use of any drugs or substances known to be strong inhibitors of CYP3A4 or CYP2D6 enzymes within 1 week prior to Day 1 or planned to be used during the overall study period.\n15. Use of any drugs or substances known to be CYP3A4 substrates with narrow therapeutic range within 1 week prior to Day 1 or planned to be used during the overall study period.\n16. Use of any drugs or substances known to be strong inducers of CYP3A4 or CYP2D6 enzymes within 4 weeks prior to Day 1 or planned to be used during the overall study period.\n17. Lactating female patient.\n18. Enrolment in a previous study on netupitant (either administered alone or in combination with palonosetron).\n19. Marked baseline prolongation of QTc interval (QTcF\\>460 millisecond \\[msec\\]). At the discretion of the investigator, criterion may be based on automatic interpretation of results.","0 Months","18 Years",{"count":53,"type":20},95,"INTERVENTIONAL",[56],"PHASE2","Chemotherapy often causes nausea and vomiting (CINV), and this is a major problem for the children being treated for cancer. To prevent this, a combination of two substances in fixed proportion (IV NEPA) was developed. The two substances are: palonosetron, an antagonist of 5 HT3 receptors, and fosnetupitant, an antagonist of NK1 receptors that transforms into netupitant in the body. The medication is administered through intravenous injection (IV- drip).\n\nThis study is built from 2 parts:\n\nPart 1: phase 2, open label Part 2: phase 3 double blind\n\nThe detailed description, study design, study milestones and eligibility criteria will reflect the Part 1 requirements",[24,59],"Nausea Post Chemotherapy",[61,62,63,64,65],"Prevention of chemotherapy-induced nausea and vomiting","highly emetogenic chemotherapy","HEC","IV NEPA","CINV","RECRUITING","2026-05-29",{"date":69,"type":34},"2026-06-01",{"date":71,"type":34},"2025-07-07",{"date":73,"type":20},"2027-12",{"name":75,"class":76},"Helsinn Healthcare SA","INDUSTRY",20,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":65,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":54,"phases":87,"briefSummary":88,"conditions":89,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":4},"100561716","phase-2-evaluating-the-efficacy-and-safety-of-hsk21542-injection-in-chemotherapy-induced-nausea-and-vomiting-100561716","NCT06593782","Evaluating the Efficacy and Safety of HSK21542 Injection in Chemotherapy-induced Nausea and Vomiting","A Multicenter, Randomized, Double-blind, Active-Controlled Dose-Finding Study of HSK21542 Injection for the Prevention of Chemotherapy-induced Nausea and Vomiting (CINV)","Inclusion Criteria:\n\n1.18 years of age or older, of either gender;\n\n2\\. Has never been treated with chemotherapy regimen and plan to receive asingle day high emetic chemotherapy regimen by intravenous infusion，including but not limited to AC regimen, carboplatin AUC ≥ 4, Camustine\\>250 mg\u002Fm2, cisplatin, and other treatment options;\n\n3\\. Diagnosed with a malignant solid tumor by histology or cytology;\n\n4\\. Has an ECOG Performance Status of 0 or 1;\n\n5\\. Predicted life expectancy of ≥3 months;\n\n6\\. Adequate bone marrow, kidney, and liver function:\n\n1. Absolute neutrophil count ≥ 1.5 × 109\u002FL, white blood cell count ≥ 3.0 × 109\u002FL;\n2. Platelet count ≥ 75 × 109\u002FL;\n3. Hemoglobin ≥ 70 g\u002FL;\n4. Aspartate transaminase (AST) ≤ 3 × ULN (≤ 5 × ULN in patients with hepatocellular carcinoma or liver metastasis);\n5. Alanine transaminase (ALT) ≤ 3 × ULN (≤ 5 × ULN in patients with hepatocellular carcinoma or liver metastasis);\n6. Serum total bilirubin ≤ 2 × ULN (≤ 3 × ULN for patients with hepatocellular carcinoma or liver metastasis);\n7. Creatinine ≤ 2 × ULN;\n\n   7\\. Subjects who agree to participate in the trial and voluntarily sign the Informed Consent Form (ICF);\n\nExclusion Criteria:\n\n1. History or evidence of any of the following diseases prior to screening:\n\n   1. Suffering from primary or metastatic malignant tumors of the central nervous system;\n   2. Suffering from epilepsy, Parkinson\\'s disease, or other central nervous system disorders that cause nausea and vomiting;\n   3. Suffering from intestinal obstruction or other digestive system diseases that may cause nausea and vomiting as determined by researchers;\n   4. Suffering from clearly diagnosed vestibular dysfunction other than motion sickness (including but not limited to peripheral vestibular syndrome, central vestibular syndrome, etc.);\n   5. History of obvious and chronic dizziness;\n   6. QT interval\\>450 ms during screening or taking concomitant medications due to prolonged QT interval or has risk factors for QT interval prolongation or correspon;\n2. Allergies or contraindications to the study drugs or other drugs specified in the protocol (including chemotherapy drugs, investigational drugs and mimetics, dorasetron, aripipitan, dexamethasone, etc.) ;\n3. Subjects who have experienced nausea, retching, or vomiting before 24 hours of randomization;\n4. Subjects who have received abdominal or pelvic radiation therapy within the first 7 days of randomization or plan to receive abdominal or pelvic radiation therapy during the study period;\n5. Subjects with a history of drug abuse, drug addiction, or alcoholism within 3 months prior to screening, where alcoholism is defined as consuming \\>2 units of alcohol on average daily (1 unit = 360 mL of beer with 5% alcohol, 45 mL of liquor with 40% alcohol or 150 mL of wine);\n6. Subjects who have participated in any investigational trial (defined as receiving investigational drug or placebo) within 1 month prior to screening;\n7. Female subjects who are pregnant or breastfeeding; female or male subjects of child-bearing potential are unwilling to use contraception throughout the entire study period and for 3 months after the study completion;\n8. Subjects judged by the investigator to be unsuitable for participating in this clinical trial for any other factors.",{"count":86,"type":20},180,[56],"This is a multicenter, randomized, double-blind, active-controlled dose-finding study. About 180 subjects who receive a high emetic chemotherapy are planned to be enrolled and randomized into three groups by a ratio of 1:1:1.",[90],"Nausea and Vomiting, Chemotherapy-Induced","2024-09-17",{"date":93,"type":34},"2024-09-19",{"date":95,"type":20},"2024-09-16",{"date":97,"type":20},"2025-09-01",{"name":99,"class":41},"First Affiliated Hospital of Wenzhou Medical University"]