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.
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.
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.
Parallel
Nutrition supplement
Dietary supplementParticipants are instructed to consume two bottles per day (providing high energy, high protein, and enriched with omega-3 fatty acids EPA/DHA) orally for 3 consecutive months alongside their normal diet.
Digital Health App Monitoring
BehavioralParticipants use a custom mobile application for 3 months to log daily supplement intake, record weekly body weight, track gastrointestinal symptoms, access nutrition education modules, and optionally complete non-invasive acoustic abdominal sound recordings.
Individualized Dietitian Consultation
Other interventionParticipants receive three 1-on-1 nutritional consultations with a Registered Dietitian (at Baseline, Month 1, and Month 3) to provide personalized dietary guidance, address symptom-related eating barriers, and optimize overall nutritional intake.
Individualized Dietitian Consultation
Other interventionParticipants receive three 1-on-1 nutritional consultations with a Registered Dietitian (at Baseline, Month 1, and Month 3) to deliver standard dietary counseling and nutritional assessment, without prescription of the study oral nutritional supplement.
Change in Patient-Generated Subjective Global Assessment (PG-SGA) Score
Continuous score evaluated using the validated PG-SGA instrument to assess changes in patient-reported symptoms, risk factors, and overall nutritional classification. Lower numerical scores indicate lower nutritional risk and improved nutritional status.
Change in Absolute Body Weight
Measured in kilograms (kg) using standard calibrated clinical scales to assess weight loss attenuation or weight gain.
Health-Related Quality of Life (EORTC QLQ-C30)
Evaluated using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). Includes global health status/QoL scales, functional scales (physical, role, emotional, cognitive, social), and symptom scales (fatigue, nausea/vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). Linear transformation converts raw scores to a range from 0 to 100.
Gastrointestinal Symptom Rating Scale (GSRS) Score
Evaluates gastrointestinal tolerance and symptom severity using a 15-item Likert scale covering 5 domains: reflux, abdominal pain, indigestion, diarrhea, and constipation. Higher scores reflect higher symptom severity.
Dietary Energy and Nutrient Intake (FFQ)
Evaluated via Food Frequency Questionnaire (FFQ) and 24-hour dietary recalls to assess total daily energy (kcal/day), macronutrient (protein, carbohydrate, fat), and micronutrient intake from food and oral supplements.
Oral Nutritional Supplement Compliance Rate
Percentage of prescribed oral nutritional supplement actually consumed
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