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.

Обзор

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. The main questions it aims to answer are: Does Nuvastatic 300 capsule significantly reduce cancer-related fatigue compared to placebo? Is Nuvastatic 300 capsule safe and well tolerated in this patient population? Researchers will compare Nuvastatic 300 capsule vs placebo to see if Nuvastatic 300 capsule improves fatigue scores and maintains an acceptable safety profile. Participants will: Receive Nuvastatic 300 capsule or placebo capsules (3 times per day) for 6 cycles of 20 days each (total \~120 treatment days). Continue 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.

Вмешательства

• Препарат Nuvastatic 300
  300mg capsule, (3 capsules X 3 times a day)
• Препарат Placebo
  300mg capsule, (3 capsules X 3 times a day)

Первичные конечные точки

• Reduction in cancer-related fatigue in breast cancer patients undergoing first-line chemotherapy, assessed after treatment with Nuvastatic versus placebo. [Срок оценки: From Screening to EOT (about 6 months)]
• Reduction in cancer-related fatigue in breast cancer patients undergoing first-line chemotherapy, assessed after treatment with Nuvastatic versus placebo. [Срок оценки: From Screening to EOT (about 6 months)]

Вторичные конечные точки (2)

• Overall QoL and functional improvement [Срок оценки: at baseline and at end of the study (about 6 months)]
• Overall QoL and functional Improvement [Срок оценки: At baseline and at end of treatment (about 6 months)]

Критерии участия

Критерии включения

• Male and female patients who are ≥18 and ≤65 years of age, who are willing to voluntarily provide consent for participation in the study.
• Patients with metastatic colorectal cancer planned or scheduled to receive standard chemotherapy treatment for at least 6 cycles respectively.
• Patients must have a confirmed diagnosis of metastatic colorectal cancer as per standard guidelines.
• 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).
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at Screening.
• Life expectancy ≥ 6 months, as per investigator's judgment.
• The patient has stable hemoglobin (≥ 9 g/dL)throughout the screening.
• 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.

Критерии исключения

• 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.
• 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.
• 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.
• Patients with any delay in chemotherapy treatment such that the screening period extends beyond 21 days.
• Patients with known central nervous system (CNS) are involved by metastatic cancer.
• 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.
• Female patients who are pregnant or breastfeeding.
• Patients with known hepatitis C virus, hepatitis B virus, HIV infection.
• 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.
• Patients with uncontrolled pain who, in the opinion of the investigator, are not eligible for the study.
• 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.
• Patients with planned therapy or treatment with another investigational agent.
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Индия · 6 центров

• Omega Hospital Chinna Gadhili — Visakhapatnam
• K R Hospital — Mysore
• Jeevanjyoti Cancer Hospital — Jalgaon
• Sangavi Multispeciality Hospital Pvt. Ltd, — Pune
• Erode Cancer Care Centre — Erode
• International Oncology Cancer Tower 1 — Kanpur

Идентификаторы

NCT: NCT07669454 · EBCT004 · NatureCeuticals Sdn Bhd

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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