Nutritional DeteriorationNCT07869290
Benefits of Nutritional Supplement in Cancer Care
A study testing Nutrition supplement, Digital Health App Monitoring and Individualized Dietitian Consultation in people with Nutritional Deterioration and Malignant Solid Tumor, run by The Hong Kong Polytechnic University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nutritional Deterioration, Malignant Solid Tumor, Cancer Cachexia
- What is being tested?
- Nutrition supplement, Digital Health App Monitoring and Individualized Dietitian Consultation
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 7 Oct 2026to 31 Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: To Explore the Benefits of Nutritional Supplement Along Chinese Cancer Patients Journey in Hong Kong
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.
Read the detailed description
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.
- Conditions
- Nutritional Deterioration, Malignant Solid Tumor, Cancer Cachexia, Cancer Malnutrition, Weight Loss, Oral Nutritional Supplementation (ONS)
- Being tested
- Nutrition supplement, Digital Health App Monitoring, Individualized Dietitian Consultation
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition supplementDietary supplement
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.
Digital Health App MonitoringBehavioural
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.
Individualized Dietitian ConsultationOther
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.
Individualized Dietitian ConsultationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| ONS + Digital Tracking + Dietitian Support | Experimental | 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. Receives: Dietary Supplement: Nutrition supplement; Behavioral: Digital Health App Monitoring; Other: Individualized Dietitian Consultation |
| Dietitian Support Alone | Active comparator | 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. Receives: Other: Individualized Dietitian Consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and Month 3
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: Baseline and Month 3
Oral Nutritional Supplement Compliance Rate
Percentage of prescribed oral nutritional supplement actually consumed
Measured: 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.
Measured: Month 1 and Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start7 Oct 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutritional DeteriorationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized in a 2:1 ratio to either the Experimental Arm (ONS + Digital Tracking App + Dietitian Support) or the Active Comparator Arm (Dietitian Support Alone) for a 3-month intervention period, followed by a 3-month observational follow-up period.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07869290
- Sponsor's protocol ID
- HSEARS20260602002
- Status last verified
- Sep 2026
- First submitted
- 1 Oct 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a commercially sponsored study, and the data are protected under the agreement with the sponsor.