A Study to See if Myestem CZ 25 mg Can Help Reduce Low Blood Counts and Weight Loss Caused by Cancer Treatment

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2026
INTERVENTION: Intervention1: Investigational Phyto Compound MYESTEM CZ 25 mg along with Standard cisplatin‐based chemotherapy: Pateint will receive phyto‐compound MYESTEM CZ 25 mg orally twice daily for 63 days Control Intervention1: Placebo Along with Standard cisplatin‐based chemotherapy: Pateint will receive placebo of phyto compound MYESTEM CZ 25 mg orally twice daily for 63 days CONDITION: Health Condition 1: C7A8‐ Other malignant neuroendocrine tumors PRIMARY OUTCOME: No occurrence of Grade 3 or Grade 4 myelosuppression will be assessed ; Neutropenia defined as an absolute neutrophil count ANC less than 1 0 into 10 raise to 9 per L ; Thrombocytopenia defined as a platelet count les than 50 into ten raise to 9 per L ; Anemia defined as hemoglobin less than 8 g per dL ; Proportion of participants with less than or equal to 5 percent reduction in body weightTimepoint: No occurrence of Grade 3 or Grade 4 myelosuppression will be assessed ; Neutropenia defined as an absolute neutrophil count ANC less than 1 0 into 10 raise to 9 per L ; Thrombocytopenia defined as a platelet count les than 50 into ten raise to 9 per L ; Anemia defined as hemoglobin less than 8 g per dL ; Proportion of participants with less than or equal to 5 percent reduction in body weight SECONDARY OUTCOME: Time from Cycle 1 Day 1 to the first occurrence of Grade greater than or equal to 3 neutropenia ; Number and proportion of Participants experiencing chemotherapy dose reductions dose delays or treatment interruptions ; Proportion of Participants who develop febrile neutropenia defined according to standard clinical criteria fever with neutropenia requiring medical intervention ; Change in the following nutritional parameters ; Serum albumin ; Serum prealbumin ; Body mass inde X; Change in patient reported quality‐of‐life scores measured using the EORTC QLQ C30 and FAACT questionnaires ; Proportion of Participants requiring hospitalization due to infection or treatment related complications ; Timepoint: During cycles 1 through end of cycle 3 INCLUSION CRITERIA: 1 Adults aged 18 years or older at the time of screnning 2 Histologically or cytologically confirmed solid malignancy for which systemic chemotherapy is planned 3 Participants must be planned to receive a cisplatin based chemotherapy regimen as part of standard of care and willing to continue standard of care throughout the study duration 4 Planned to receive at least three cycles of a myelosuppressive chemotherapy regimen as per the treatment oncologist assessment 5 Eastern Cooperative Oncology Group ECOG Performance Status of 0 to 2 at screening 6 Female participants of childbearing potential must have a negative pregnancy test at screening and prior to randomization Cycle 1 Day 1 7 Adequate baseline hematologic function and adequate organ function renal hepatic and cardiac defined as Absolute neutrophil count ANC 1.5 into 10 9 per L or greater Platelet count 100 into 10 9 per L or gre
Epistemonikos ID: 78c72c393c3571cf480a940abe1c3b8c66f5bbb5
First added on: Oct 08, 2026