4.6. Study Procedure
cancer, tumor
ADVERSE EVENTS, CANCER, TUMOR, SECONDARY
Baseline assessment was performed before the randomization, including physical examination, cancer size, location and stage, complete blood count, and liver and kidney function tests. General information about the participants, including age, sex, height, and medical history was retrieved from patients’ charts. The participants were asked to consume either 2 cups of 100 g (total of 200 g) of Nutri-Jelly or Nutri-PEITC Jelly in the morning on Monday to Friday (5 days a week) for 3 months. All participants were asked to record their use of the product daily in subject diaries to ensure adherence to the intervention protocol. The intake of paracetamol was also recorded. The outcome measures were evaluated at 0, 1, and 3 months after interventions. The primary outcome measure included adverse events, health-related quality of life (HRQoL), nutritional status, progression-free survival (PFS), and tumor response. The secondary outcome measures were functional assessment outcome (Karnofsky performance status scale: KPS) and serum p53 and cytochrome c levels.Questionnaires, body weight measurements, blood collection, and tumor size measurement by caliper were performed at all time points. CT scan was performed at 0 and 3 months.