Benefits of Nutritional Supplement in Cancer Care

NCT07869290 | Not Yet Recruiting DMC

• 1 other identifier: HSEARS20260602002
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Nutritional Deterioration; Malignant Solid Tumor; Cancer Cachexia; Cancer Malnutrition; Weight Loss; Oral Nutritional Supplementation (ONS); Medical Nutrition Therapy; Quality of Life

Outcome Measures

Primary Outcomes (2)

• 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

• Change in Absolute Body Weight

  Measured in kilograms (kg) using standard calibrated clinical scales to assess weight loss attenuation or weight gain.

  Baseline and Month 3

Secondary Outcomes (5)

• Health-Related Quality of Life (EORTC QLQ-C30)

  Baseline, Month 1, Month 3, and Month 6

• Gastrointestinal Symptom Rating Scale (GSRS) Score

  Baseline, Week 1, Week 2, Month 1, and Month 3

• Dietary Energy and Nutrient Intake (FFQ)

  Baseline and Month 3

• Oral Nutritional Supplement Compliance Rate

  Month 1 and Month 3

• Digital Health Application Engagement Rate

  Month 1 and Month 3

Study Arms (2)

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.

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.

Other: Individualized Dietitian Consultation

Interventions

Nutrition supplement DIETARY_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.

ONS + Digital Tracking + Dietitian Support

Digital Health App Monitoring BEHAVIORAL

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.

ONS + Digital Tracking + Dietitian Support

Individualized Dietitian Consultation OTHER

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.

ONS + Digital Tracking + Dietitian Support

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ka Hei Kenneth Lo, PhD

CONTACT

852-3400-8778; kenneth.kh.lo@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Neither participants, care providers, nor outcome assessors are blinded due to the nature of the dietary intervention.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 1, 2026
• First Posted: October 9, 2026
• Study Start: October 7, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: October 9, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share