Benefits of Nutritional Supplement in Cancer Care

This is an exploratory, open-label, 2:1 randomized controlled trial conducted across collaborating oncology clinics and extended research networks in Hong Kong. A total of 100 adult cancer patients with solid tumors who are at nutritional risk (PG-SGA ≥4 or NRS-2002 ≥3) will be enrolled. Participants are randomized into two groups for a 3-month intervention period, followed by a 3-month observational follow-up (6 months total study duration). The primary outcome is the change in nutritional status from baseline to Month 3, evaluated using body weight, BMI, and the Patient-Generated Subjective Global Assessment (PG-SGA) score. Secondary outcomes include changes in Quality of Life (EORTC QLQ-C30), gastrointestinal tolerance (GSRS), dietary habits (FFQ), product compliance, healthcare utilization (hospital readmission rates), and long-term nutritional maintenance through Month 6.

Inclusion Criteria: * Age ≥ 18 years at the time of signing informed consent. * Pathologically confirmed diagnosis of a malignant solid tumor. * Scheduled to initiate or currently receiving active non-surgical or surgical anticancer therapy (including chemotherapy, concurrent chemoradiotherapy, immunotherapy, targeted therapy, or surgical intervention). * Able to initiate oral nutritional supplementation (ONS) within 10 days of enrollment. * Anticipated remaining duration of active anticancer treatment regimen of ≥3 months. * Identified as being at nutritional risk at screening, defined as meeting at least one of the following criteria: * Patient-Generated Subjective Global Assessment (PG-SGA) score ≥ 4, OR * Nutritional Risk Screening 2002 (NRS-2002) score ≥ 3. * Eastern Cooperative Oncology Group (ECOG) Performance Status \< 3 (ECOG 0, 1, or 2). * Anticipated life expectancy \> 6 months as assessed by the treating oncologist. * Possesses a functional smartphone and demonstrates the cognitive and physical ability to operate the study mobile application. * Able to understand the nature of the study and willing to provide written informed consent. Exclusion Criteria: * Sole active anticancer therapy is endocrine/hormonal monotherapy. * Known severe allergy, hypersensitivity, or intolerance to any component of the study product, including cow's milk protein or soy. * Use of medications known to significantly modulate body weight or metabolism (e.g., high-dose systemic corticosteroids \[\> 20 mg/day prednisone equivalent\], megestrol acetate, or fish oil/omega-3 supplements) within 30 days prior to baseline. * Presence of severe generalized edema, gross ascites, or significant fluid overload that compromises accurate body weight assessment. * Major non-cancer comorbidities that prevent safe participation or interfere with study assessments, including severe active gastrointestinal diseases (e.g., severe inflammatory bowel disease, short bowel syndrome), end-stage renal disease (chronic renal failure requiring dialysis), uncontrolled diabetes mellitus, acute pancreatitis, or active HIV infection. * Currently dependent on total enteral tube feeding or parenteral nutrition, or anticipated to require exclusive enteral/parenteral nutrition within 3 months. * Female participants who are pregnant or currently breastfeeding. * Concurrent participation in another interventional clinical trial or administration of an investigational drug/agent within 30 days prior to baseline screening.