[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Natureceuticals Sdn Bhd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":89},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,48,72],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100644031","phase-3-nuvastatic-phase-iii-trial-for-fatigue-in-triple-negative-breast-cancer-100644031",false,"NCT07669467","Nuvastatic® Phase III Trial for Fatigue in Triple-Negative Breast Cancer","A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of Nuvastatic® 300 mg Capsules in Reducing Chemotherapy-Induced Fatigue in Patients With Metastatic Triple-Negative Breast Cancer Receiving Standard Chemotherapy","NuvastaticTM","Inclusion Criteria:\n\n* Female patients aged ≥ 18 years and ≤ 65 years who are willing to voluntarily provide consent for participation in the study.\n* Patients with confirmed triple negative metastatic breast cancer who are planned or scheduled to receive standard chemotherapy treatment for at least 4 to 6 cycles respectively.\n* Patients must have a confirmed diagnosis of triple negative metastatic breast cancer as per standard guidelines.\n* Patients must have at least one tumour lesion with ≥ 1cm in one dimension that is radiographically apparent on computed tomography (CT) or magnetic resonance imaging (MRI).\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at screening.\n* The patient has stable haemoglobin (≥ 9 g\u002FdL) throughout the screening.\n* Life expectancy ≥ 6 months, as per the investigator's judgment.\n* Patients with co-morbidities or medical conditions including Type 2 diabetes mellitus (DM) and hypertension who are deemed stable by the investigator can be included in the study.\n* At screening, patients with stable fatigue, newly developed fatigue, or worsening fatigue scores as assessed by the Brief Fatigue Inventory (BFI) should be included.\n\nExclusion Criteria:\n\n* Patients who have any untreated reversible medical condition which may cause fatigue (e.g. major metabolic or electrolyte disturbance, active infection, endocrine abnormalities) as per the investigator's clinical judgment.\n* Patients with an inability to understand local language(s) for scales used for evaluations i.e. VAFS, BFI AND SF-36.\n* Patients who have received concurrent stimulant medication (e.g. dextroamphetamine or methylphenidate) during the screening period or any medication which may interfere with the study drug.\n* Patients with any delay in chemotherapy treatment such that the screening period extends beyond 21 days.\n* Patients with known central nervous system (CNS) involvement.\n* Patients with any serious, uncontrolled, non-malignant medical or psychiatric disorder, or any other medical condition which in the opinion of the investigator, may affect the patient's safety or study participation and conduct.\n* Female patients who are pregnant or breastfeeding.\n* Patients with known hepatitis C virus, hepatitis B virus, HIV infection.\n* Patients who have nausea and vomiting or any gastrointestinal disorder that is severe enough to interfere with study drug absorption in the opinion of the investigator.\n* Patients with uncontrolled pain, who in the opinion of the investigator are not eligible for the study.\n* Patients with known hypersensitivity or intolerance of rosmarinic acid, caffeic acid, and other related phenolic compounds as well as excipients in the Nuvastatic® 300 mg or placebo treatment.\n* Patients with planned therapy or treatment with another investigational agent.\n* Previous exposure to any investigational agent within 4 weeks prior to screening, or planned administration of an investigational agent, other than as specified by this protocol, during the study period.","FEMALE","18 Years","65 Years",{"count":21,"type":22},250,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","The goal of this clinical trial is to evaluate whether Nuvastatic 300 mg capsules can reduce cancer-related fatigue in adult patients with colon cancer undergoing first-line chemotherapy.\n\nThe main questions it aims to answer are:\n\n* Does Nuvastatic 300 mg capsules significantly reduce cancer-related fatigue compared to placebo?\n* Is Nuvastatic 300 mg capsules safe and well tolerated in this patient population?\n\nResearchers will compare Nuvastatic 300 mg capsules vs placebo to see if Nuvastatic 300 capsule improves fatigue scores and maintains an acceptable safety profile.\n\nParticipants will:\n\n* Receive Nuvastatic 300 mg capsules or placebo capsules (3 times per day) for 3 cycles of 20 days each (total \\~60 treatment days).\n* Continue their standard first-line chemotherapy regimen.\n* Provide blood sample assessments at Screening and End of Treatment.\n* Complete patient diaries and fatigue assessments as per protocol.",[28,29],"Fatigue Related to Cancer Treatment","Breast Cancer",[31,29,32,33,34],"Nuvastatic","Cancer related fatigue","Randomized double blind placebo controlled trail","First-Line Chemotherapy","RECRUITING","2026-06-22",{"date":38,"type":39},"2026-06-25","ACTUAL",{"date":41,"type":39},"2025-10-01",{"date":43,"type":22},"2026-10-30",{"name":45,"class":46},"Natureceuticals Sdn Bhd","INDUSTRY",6,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":15,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":55,"minAge":18,"maxAge":19,"enrollmentInfo":56,"targetDuration":4,"studyType":23,"phases":58,"briefSummary":59,"conditions":60,"keywords":63,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":66,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":47},"100643932","phase-3-evaluation-of-nuvastatictm-in-reducing-cancer-related-fatigue-in-stage-iv-colon-cancer-patients-undergoing-first-line-chemotherapy-100643932","NCT07669519","Evaluation of NuvastaticTM in Reducing Cancer-Related Fatigue in Stage IV Colon Cancer Patients Undergoing First-Line Chemotherapy","Phase III Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of NuvastaticTM in Reducing Cancer-Related Fatigue in Stage IV Colon Cancer Patients Undergoing First-Line Chemotherapy","Inclusion Criteria:\n\n1. Male and female Patients who are ≥18 and ≤65 years of age, who are willing to voluntarily provide consent for participation in the study.\n2. Patients with colon cancer planned or scheduled to receive standard chemotherapy treatment for at least 3 cycles respectively.\n3. Patients must have a confirmed diagnosis of colon cancer as per standard guideline.\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at Screening.\n5. The patient has stable haemoglobin (≥ 9 g\u002FdL) throughout the screening.\n6. Life expectancy ≥ 6 months, as per Investigator's judgment\n7. Patients with co-morbidities or medical conditions including Type 2 DM, hypertension and are deemed stable by the investigator can be included in the study\n8. At screening patients with stable fatigue, has a newly developed fatigue OR worsening of fatigue scoring as assessed by BFI should be included.\n9. Starting first-line chemo\n\nExclusion Criteria:\n\n1. Patients who have any untreated reversible medical condition which may cause fatigue (e.g. metabolic disturbance, infection, endocrine abnormalities) as per the Investigator's clinical judgment.\n2. Patients who have stage IV Disease\n3. Patients who have received concurrent stimulant medication (e.g. dextroamphetamine or methylphenidate) during the screening period or any medication which may interfere with study drug.\n4. Prior metastatic chemo, targeted\u002Fimmunotherapy, severe comorbidities\n5. Female patients who are pregnant or breast-feeding.\n6. Patients with known hepatitis C virus, hepatitis B virus, HIV infection.\n7. Patients who have nausea and vomiting or any gastrointestinal disorder that is severe enough to interfere with study drug absorption in the opinion of the Investigator.\n8. Patients with uncontrolled pain, who in the opinion of the Investigator are not eligible for the study. '\n9. Patients with planned therapy or treatment with another investigational agent.\n10. Previous exposure to any investigational agent within 4 weeks prior to screening, or planned administration of an Investigational agent, other than as specified by this protocol, during the study period.","ALL",{"count":57,"type":22},180,[25],"The goal of this clinical trial is to evaluate whether Nuvastatic can reduce cancer-related fatigue in adult patients with colon cancer undergoing first-line chemotherapy.\n\nThe main questions it aims to answer are:\n\nDoes Nuvastatic significantly reduce cancer-related fatigue compared to placebo? Is Nuvastatic safe and well tolerated in this patient population?\n\nResearchers will compare Nuvastatic vs placebo to see if Nuvastatic improves fatigue scores and maintains an acceptable safety profile.\n\nParticipants will:\n\nReceive Nuvastatic or placebo sachets (3 times per day) for 3 cycles of 20 days each (total \\~60 treatment days).\n\nContinue their standard first-line chemotherapy regimen. Provide blood samples for biomarkers (CEA, CA-125) at Screening and End of Treatment.\n\nComplete patient diaries and fatigue assessments as per protocol.",[61,62],"Fatigue","Colon Cancer",[62,64,31,65,34],"Cancer-Related Fatigue","Randomized Double-Blind Placebo-Controlled Trial",{"date":38,"type":39},{"date":68,"type":39},"2025-08-18",{"date":70,"type":22},"2027-03-31",{"name":45,"class":46},{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":76,"acronym":15,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":55,"minAge":18,"maxAge":19,"enrollmentInfo":78,"targetDuration":4,"studyType":23,"phases":79,"briefSummary":80,"conditions":81,"keywords":82,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":84,"startDateStruct":85,"completionDateStruct":86,"leadSponsor":88,"locationsCount":47},"100643923","phase-3-a-randomized-double-blind-placebo-controlled-parallel-group-comparative-phase-iii-study-to-evaluate-the-efficacy-and-safety-of-nuvastatic-300mg-capsule-in-reducing-cancer-tumor-in-patients-with-metastatic-colorectal-cancer-receiving-standard-chemotherapy-100643923","NCT07669454","A Randomized, Double-blind, Placebo-controlled, Parallel-group, Comparative, Phase III Study to Evaluate the Efficacy and Safety of Nuvastatic® 300mg Capsule in Reducing Cancer-Tumor in Patients With Metastatic Colorectal Cancer Receiving Standard Chemotherapy.","Inclusion Criteria:\n\n* Male and female patients who are ≥18 and ≤65 years of age, who are willing to voluntarily provide consent for participation in the study.\n* Patients with metastatic colorectal cancer planned or scheduled to receive standard chemotherapy treatment for at least 6 cycles respectively.\n* Patients must have a confirmed diagnosis of metastatic colorectal cancer as per standard guidelines.\n* Patients must have at least one tumor lesion with ≥ 1cm in one dimension that is radiographically apparent on computed tomography (CT) or magnetic resonance imaging (MRI).\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at Screening.\n* Life expectancy ≥ 6 months, as per investigator's judgment.\n* The patient has stable hemoglobin (≥ 9 g\u002FdL)throughout the screening.\n* Patients with co-morbidities or medical conditions including Type 2 diabetes mellitus (DM), hypertension who are deemed stable by the investigator can be included in the study.\n\nExclusion Criteria:\n\n* Patients who have any untreated reversible medical condition which may cause fatigue (e.g. metabolic disturbance, infection, endocrine abnormalities) as per the investigator's clinical judgment.\n* Patients with an inability to understand local language(s) for scales used for evaluations, i.e., EORTC QLQ-C30, BFI, SF-36 and VAS-F.\n* Patients who have received concurrent stimulant medication (e.g. dextroamphetamine or methylphenidate) during the screening period or any medication which may interfere with the study drug.\n* Patients with any delay in chemotherapy treatment such that the screening period extends beyond 21 days.\n* Patients with known central nervous system (CNS) are involved by metastatic cancer.\n* Patients with any serious, uncontrolled, non-malignant medical or psychiatric disorder, or any other medical condition which in the opinion of the investigator may affect the patient's safety or study participation and conduct.\n* Female patients who are pregnant or breastfeeding.\n* Patients with known hepatitis C virus, hepatitis B virus, HIV infection.\n* Patients who have nausea and vomiting or any gastrointestinal disorder that is severe enough to interfere with study drug absorption in the opinion of the investigator.\n* Patients with uncontrolled pain who, in the opinion of the investigator, are not eligible for the study.\n* Patients with known hypersensitivity or intolerance of rosmarinic acid, caffeic acid, and other related phenolic compounds as well as excipients in the Nuvastatic® 300 mg or placebo treatment.\n* Patients with planned therapy or treatment with another investigational agent.\n* Previous exposure to any investigational agent within 4 weeks prior to screening, or planned administration of an Investigational agent, other than as specified by this protocol, during the study period.",{"count":21,"type":22},[25],"The goal of this clinical trial is to evaluate whether Nuvastatic 300 capsule can reduce cancer-related fatigue in adult patients with colon cancer undergoing first-line chemotherapy.\n\nThe main questions it aims to answer are:\n\nDoes Nuvastatic 300 capsule significantly reduce cancer-related fatigue compared to placebo? Is Nuvastatic 300 capsule safe and well tolerated in this patient population?\n\nResearchers will compare Nuvastatic 300 capsule vs placebo to see if Nuvastatic 300 capsule improves fatigue scores and maintains an acceptable safety profile.\n\nParticipants will:\n\nReceive Nuvastatic 300 capsule or placebo capsules (3 times per day) for 6 cycles of 20 days each (total \\~120 treatment days).\n\nContinue their standard first-line chemotherapy regimen. Provide blood samples assessment at Screening and End of Treatment. Complete patient diaries and fatigue assessments as per protocol.",[28,62],[31,62,32,83,34],"Randomized double blind placebo controlled trial",{"date":38,"type":39},{"date":41,"type":39},{"date":87,"type":22},"2026-11-30",{"name":45,"class":46},""]