[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659636":3},{"organization":4,"outcomesModule":7,"designInfo":36,"detailedDescription":44,"studyPopulation":35,"armGroups":45,"interventions":59,"overallOfficials":35,"centralContacts":77,"locations":35,"responsibleParty":83,"collaborators":35,"id":85,"slug":86,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":35,"eligibilityCriteria":91,"healthyVolunteers":87,"sex":92,"minAge":93,"maxAge":35,"enrollmentInfo":94,"targetDuration":35,"studyType":97,"phases":98,"briefSummary":100,"conditions":101,"keywords":35,"overallStatus":110,"whyStopped":35,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":116,"leadSponsor":118,"locationsCount":35},{"fullName":5,"class":6},"The Hong Kong Polytechnic University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":35},[9,13],{"measure":10,"description":11,"timeFrame":12},"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.","Baseline and Month 3",{"measure":14,"description":15,"timeFrame":12},"Change in Absolute Body Weight","Measured in kilograms (kg) using standard calibrated clinical scales to assess weight loss attenuation or weight gain.",[17,21,25,28,32],{"measure":18,"description":19,"timeFrame":20},"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\u002FQoL scales, functional scales (physical, role, emotional, cognitive, social), and symptom scales (fatigue, nausea\u002Fvomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). Linear transformation converts raw scores to a range from 0 to 100.","Baseline, Month 1, Month 3, and Month 6",{"measure":22,"description":23,"timeFrame":24},"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.","Baseline, Week 1, Week 2, Month 1, and Month 3",{"measure":26,"description":27,"timeFrame":12},"Dietary Energy and Nutrient Intake (FFQ)","Evaluated via Food Frequency Questionnaire (FFQ) and 24-hour dietary recalls to assess total daily energy (kcal\u002Fday), macronutrient (protein, carbohydrate, fat), and micronutrient intake from food and oral supplements.",{"measure":29,"description":30,"timeFrame":31},"Oral Nutritional Supplement Compliance Rate","Percentage of prescribed oral nutritional supplement actually consumed","Month 1 and Month 3",{"measure":33,"description":34,"timeFrame":31},"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.",null,{"allocation":37,"interventionModel":38,"interventionModelDescription":39,"primaryPurpose":40,"observationalModel":35,"timePerspective":35,"maskingInfo":41},"RANDOMIZED","PARALLEL","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.","SUPPORTIVE_CARE",{"masking":42,"maskingDescription":43,"whoMasked":35},"NONE","Neither participants, care providers, nor outcome assessors are blinded due to the nature of the dietary intervention.","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.\n\nThe 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.\n\nAdults 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 \\\u003C 3; life expectancy \\>6 months; possess and able to use a smartphone for digital monitoring; written informed consent.\n\nThe 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.",[46,54],{"label":47,"type":48,"description":49,"interventionNames":50},"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.",[51,52,53],"Dietary Supplement: Nutrition supplement","Behavioral: Digital Health App Monitoring","Other: Individualized Dietitian Consultation",{"label":55,"type":56,"description":57,"interventionNames":58},"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.",[53],[60,65,70,74],{"type":61,"name":62,"description":63,"armGroupLabels":64,"otherNames":35},"DIETARY_SUPPLEMENT","Nutrition supplement","Participants are instructed to consume two bottles per day (providing high energy, high protein, and enriched with omega-3 fatty acids EPA\u002FDHA) orally for 3 consecutive months alongside their normal diet.",[47],{"type":66,"name":67,"description":68,"armGroupLabels":69,"otherNames":35},"BEHAVIORAL","Digital Health App Monitoring","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.",[47],{"type":6,"name":71,"description":72,"armGroupLabels":73,"otherNames":35},"Individualized Dietitian Consultation","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.",[47],{"type":6,"name":71,"description":75,"armGroupLabels":76,"otherNames":35},"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.",[55],[78],{"name":79,"role":80,"phone":81,"phoneExt":35,"email":82},"Ka Hei Kenneth Lo, PhD","CONTACT","852-3400-8778","kenneth.kh.lo@polyu.edu.hk",{"type":84,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR","100659636","benefits-of-nutritional-supplement-in-cancer-care-100659636",false,"NCT07869290","Benefits of Nutritional Supplement in Cancer Care","To Explore the Benefits of Nutritional Supplement Along Chinese Cancer Patients Journey in Hong Kong","Inclusion Criteria:\n\n* Age ≥ 18 years at the time of signing informed consent.\n* Pathologically confirmed diagnosis of a malignant solid tumor.\n* Scheduled to initiate or currently receiving active non-surgical or surgical anticancer therapy (including chemotherapy, concurrent chemoradiotherapy, immunotherapy, targeted therapy, or surgical intervention).\n* Able to initiate oral nutritional supplementation (ONS) within 10 days of enrollment.\n* Anticipated remaining duration of active anticancer treatment regimen of ≥3 months.\n* Identified as being at nutritional risk at screening, defined as meeting at least one of the following criteria:\n* Patient-Generated Subjective Global Assessment (PG-SGA) score ≥ 4, OR\n* Nutritional Risk Screening 2002 (NRS-2002) score ≥ 3.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status \\\u003C 3 (ECOG 0, 1, or 2).\n* Anticipated life expectancy \\> 6 months as assessed by the treating oncologist.\n* Possesses a functional smartphone and demonstrates the cognitive and physical ability to operate the study mobile application.\n* Able to understand the nature of the study and willing to provide written informed consent.\n\nExclusion Criteria:\n\n* Sole active anticancer therapy is endocrine\u002Fhormonal monotherapy.\n* Known severe allergy, hypersensitivity, or intolerance to any component of the study product, including cow's milk protein or soy.\n* Use of medications known to significantly modulate body weight or metabolism (e.g., high-dose systemic corticosteroids \\[\\> 20 mg\u002Fday prednisone equivalent\\], megestrol acetate, or fish oil\u002Fomega-3 supplements) within 30 days prior to baseline.\n* Presence of severe generalized edema, gross ascites, or significant fluid overload that compromises accurate body weight assessment.\n* 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.\n* Currently dependent on total enteral tube feeding or parenteral nutrition, or anticipated to require exclusive enteral\u002Fparenteral nutrition within 3 months.\n* Female participants who are pregnant or currently breastfeeding.\n* Concurrent participation in another interventional clinical trial or administration of an investigational drug\u002Fagent within 30 days prior to baseline screening.","ALL","18 Years",{"count":95,"type":96},100,"ESTIMATED","INTERVENTIONAL",[99],"NA","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).\n\nThe 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.",[102,103,104,105,106,107,108,109],"Nutritional Deterioration","Malignant Solid Tumor","Cancer Cachexia","Cancer Malnutrition","Weight Loss","Oral Nutritional Supplementation (ONS)","Medical Nutrition Therapy","Quality of Life","NOT_YET_RECRUITING","2026-10-07",{"date":113,"type":114},"2026-10-09","ACTUAL",{"date":111,"type":96},{"date":117,"type":96},"2027-12-31",{"name":5,"class":6}]