Erode

Researchers are evaluating the effects of Nuvastatic 300 capsule on reducing fatigue related to cancer treatment in adults with metastatic colon cancer who are undergoing first-line chemotherapy. The main goals are to determine if Nuvastatic 300 capsule can significantly reduce cancer-related fatigue compared to a placebo and to assess its safety and tolerability in this patient group. This is a phase III randomized, double-blind, placebo-controlled study sponsored by Natureceuticals Sdn Bhd. Participants will receive either Nuvastatic 300 capsules or placebo capsules, taken three times daily for six cycles lasting about 20 days each, totaling approximately 120 treatment days. All participants will continue their standard chemotherapy during the trial. Blood samples will be collected at screening and at the end of treatment to monitor health and treatment effects. During the study, participants will complete diaries and fatigue assessments according to the protocol. Researchers will measure reduction in cancer-related fatigue from screening to the end of treatment, as well as overall quality of life and functional improvements. The trial includes safety monitoring and will last about six months from screening through treatment completion.

Researchers are evaluating the safety and effectiveness of darolutamide alongside standard androgen deprivation therapy ADT in Indian men with high-risk non-metastatic castration-resistant prostate cancer nmCRPC. This type of prostate cancer continues to progress despite very low testosterone levels. The study aims to collect detailed safety data and compare it with previous research involving darolutamide, which did not include Indian participants. Participants will take darolutamide tablets orally twice daily along with their ongoing ADT. They will have visits every 16 weeks from the start until their cancer worsens, they develop medical issues, leave the study, or the study ends. During these visits, various tests and assessments will be performed, including blood and urine sampling, physical exams, heart activity monitoring with ECG, and evaluation of daily living abilities using the ECOG performance status. Throughout the study, researchers will monitor adverse events, lab abnormalities, vital signs, and changes in participants health status up to approximately 15 months. They will also assess changes in prostate-specific antigen PSA levels and track the time to additional cancer treatments. Participants may continue darolutamide after the trial if they benefit from it. The total study duration extends up to the primary completion date in April 2027.

Researchers are evaluating whether Nuvastatic 300 mg capsules can reduce cancer-related fatigue in adult women with metastatic triple-negative breast cancer undergoing first-line chemotherapy. This Phase III clinical trial compares Nuvastatic capsules to placebo to assess their effect on fatigue scores and safety in this patient population. Participants will take either Nuvastatic 300 mg capsules or placebo capsules three times a day for three cycles of 20 days each, totaling about 60 treatment days, while continuing their standard chemotherapy regimen. Blood samples will be collected at screening and at the end of treatment. Patients will also complete diaries and fatigue assessments according to the study protocol. During the trial, participants will be monitored through fatigue assessments and quality of life evaluations at baseline and study end, approximately six months later. The primary outcome is the reduction of cancer-related fatigue from screening to end of treatment. Safety and tolerability will be observed alongside quality of life and functional improvements. The total study duration includes screening, treatment, and follow-up assessments.