An interventional study of Nutrition supplement and Digital Health App Monitoring in Nutritional Deterioration, Malignant Solid Tumor and Cancer Cachexia, sponsored by The Hong Kong Polytechnic University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by The Hong Kong Polytechnic University · Not applicable, Interventional, and Supportive 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.
Malnutrition, cachexia, and functional decline are frequent complications among cancer patients undergoing active therapies (chemotherapy, concurrent chemoradiotherapy, immunotherapy, targeted therapy, or surgery). These conditions significantly impair treatment tolerance, increase complication rates, reduce quality of life (QoL), and compromise clinical outcomes. While medical nutrition therapy (MNT) is an essential component of comprehensive oncology care, its structured integration into post-discharge and outpatient care remains variable across Greater China.
The study product is a high-energy, high-protein oral nutritional supplement enriched with n-3 polyunsaturated fatty acids, formulated in alignment with ESPEN and ESMO guidelines for cancer care. This exploratory trial aims to evaluate an integrated MNT delivery model, combining targeted oral nutritional supplementation, professional dietetic counseling, and digital health monitoring, establish an evidence-based clinical pathway for oncology nutrition support.
Adults aged ≥18 years with pathologically confirmed malignant solid tumors; scheduled to start or currently receiving active anticancer treatment (surgery, chemotherapy, concurrent chemoradiotherapy, immunotherapy, targeted therapy, or combination); able to initiate ONS within 10 days of enrollment; anticipated remaining active treatment duration ≥ 3 months; at nutritional risk (PG-SGA ≥ 4 or NRS-2002 ≥ 3); ECOG Performance Status \< 3; life expectancy >6 months; possess and able to use a smartphone for digital monitoring; written informed consent.
The study spans 6 months (3 months active intervention + 3 months post-intervention follow-up) with evaluations at Baseline, Week 1, Week 2, Month 1, Month 3, and Month 6. An Intention-to-Treat (ITT) analysis using linear mixed models for repeated measures will evaluate continuous outcomes across visits. A total sample size of n = 100 (67 intervention, 33 control) provides 80% power at a two-sided α = 0.05 to detect a standardized effect size of d = 0.7 in mean weight change between groups at 3 months, accounting for an anticipated 20% drop-out rate. Per-protocol sensitivity analyses will be conducted for participants with 80% supplement intake and 80% attendance at dietitian consultations.
1,818 studies on the registry are indexed under Weight Loss; 286 are open to participants now.
This study's planned enrollment of 100 is above the median of 73 across 1,540 interventional studies indexed under Weight Loss.
Browse Weight Loss studies →The Hong Kong Polytechnic University is the lead sponsor of 676 studies on the registry; 254 are open to participants now.
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Exclusion Criteria:
Participants in this group receive a 3-month multi-component medical nutrition therapy (MNT) package consisting of daily oral nutritional supplementation, continuous digital health monitoring via a dedicated mobile app, and monthly consultations with a Registered Dietitian, followed by a 3-month observational follow-up.
Dietary Supplement: Nutrition supplement · Behavioral: Digital Health App Monitoring · Other: Individualized Dietitian Consultation
Participants in this group receive standard care combined with monthly individualized nutritional consultations with a Registered Dietitian over the 3-month study period, without receiving the study supplement or access to the digital tracking app, followed by a 3-month observational follow-up.
Other: Individualized Dietitian Consultation
Participants 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.
Participants 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.
Participants 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.
Participants 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.
Time frame: Baseline and Month 3
Change in Absolute Body Weight
Measured in kilograms (kg) using standard calibrated clinical scales to assess weight loss attenuation or weight gain.
Time frame: Baseline and Month 3
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.
Time frame: Baseline, Month 1, Month 3, and Month 6
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.
Time frame: Baseline, Week 1, Week 2, Month 1, and Month 3
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.
Time frame: Baseline and Month 3
Oral Nutritional Supplement Compliance Rate
Percentage of prescribed oral nutritional supplement actually consumed
Time frame: Month 1 and Month 3
Digital Health Application Engagement Rate
Measured as the total frequency of log submissions per week, module completion rates for educational content, and active app interaction days over the intervention period.
Time frame: Month 1 and Month 3
No study locations are listed for this record.
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Plan to share: No — This is a commercially sponsored study, and the data are protected under the agreement with the sponsor.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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