Evaluation of NuvastaticTM in Reducing Cancer-Related Fatigue in Colon Cancer Patients Undergoing First-Line Chemotherapy

Korábbi kezelés

• 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.
• Prior metastatic chemo, targeted/immunotherapy, severe comorbidities
• 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.

Más betegség

• 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 who have stage IV Disease
• 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.

Egyéb

• Female patients who are pregnant or breast-feeding.
• Patients with uncontrolled pain, who in the opinion of the Investigator are not eligible for the study. '

• 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 colon cancer planned or scheduled to receive standard chemotherapy treatment for at least 3 cycles respectively.
• Patients must have a confirmed diagnosis of colon cancer as per standard guideline.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at Screening.
• The patient has stable haemoglobin (≥ 9 g/dL) throughout the screening.
• Life expectancy ≥ 6 months, as per Investigator's judgment
• 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
• At screening patients with stable fatigue, has a newly developed fatigue OR worsening of fatigue scoring as assessed by BFI should be included.
• Starting first-line chemo