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NOT YET RECRUITING
NCT07869290
NA

Benefits of Nutritional Supplement in Cancer Care

Sponsor: The Hong Kong Polytechnic University

View on ClinicalTrials.gov

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.

Official title: To Explore the Benefits of Nutritional Supplement Along Chinese Cancer Patients Journey in Hong Kong

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2026-10-07

Completion Date

2027-12-31

Last Updated

2026-10-09

Healthy Volunteers

No

Interventions

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/DHA) orally for 3 consecutive months alongside their normal diet.

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.

OTHER

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.

OTHER

Individualized Dietitian Consultation

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.