NCT03545490 is a Phase 2 clinical trial of Early nutritional intervention in Malnutrition, sponsored by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University.

What drugs are being tested in NCT03545490?

Interventions in NCT03545490: Early nutritional intervention.

What condition does NCT03545490 study?

NCT03545490 studies Malnutrition.

Is NCT03545490 still recruiting?

NCT03545490 is currently completed. Last updated 18 December 2023.

Last reviewed 2023-12-18 · How we verify

NCT03545490

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Early Enteral Nutritional Supplementation on Patients With Oral and Oropharyngeal Cancer Undergoing Radio(Chemo)Therapy After Surgical

Completed Phase 2 Last updated 18 December 2023

What this trial tests

Phase 2 trial testing Early nutritional intervention in Malnutrition in 110 participants. Completed in 30 June 2022.

Timeline

1 June 2017

Primary endpoint
31 October 2020

30 June 2022

Quick facts

Lead sponsor	Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	110
Start date	1 June 2017
Primary completion	31 October 2020
Estimated completion	30 June 2022
Sites	1 location across China

Drugs / interventions tested

Early nutritional intervention

Conditions studied

Malnutrition — all drugs for Malnutrition →

Sponsor

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Who can join

Adults 18 to 70, any sex, with Malnutrition. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The target population in the present study is Chinese patients with oral and oropharyngeal cancer who plan to receive radio(chemo)therapy after surgical resection in the outpatient department. Investigators hypothesize that early enteral nutrition intervention, which is initiated 2 weeks before the start of postoperative radio(chemo)therapy treatment and added on demand during radiotherapy, will improve patients' nutritional status, tolerability to the radio(chemo)therapy, quality of life, and other clinical outcomes compared to commencement of oral nutritional supplements during the course of irradiation treatment. There are two cohorts in this trial, cohort 1 included patients with oral nutritional supplements and cohort 2 included patients with tube feeding (nasogastric tube or percutaneous endoscopic gastrostomy).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Effectiveness of Early Oral Nutritional Supplementation in Preventing Weight Loss in Head and Neck Cancer Patients Undergoing Postoperative Radiotherapy or Chemoradiotherapy: A Prospective Randomized Controlled Trial.
Jiang W, Zhang H, Dou S, He Y, et al · · 2025 · cited 1× · PMID 39903480 · DOI 10.1080/27697061.2025.2458277

Verify or expand the search:

Other recruiting trials for Malnutrition

Currently open trials in the same condition.

NCT07162701 — Body Composition Assessment and Monitoring in Inflammatory Bowel Disease · recruiting
NCT05324475 — Maintaining Immune and Mitochondrial Functions in Old Adults With SAfe Nutrition. · NA · recruiting
NCT06825377 — Comparing High-protein Vs. Standard Protein Nutritional Support in Critically Ill Patients At Risk for Refeeding Syndrom · NA · recruiting
NCT06687291 — Cognitive Impact Associated With Surgery For Gastric Or Esophageal Cancer · recruiting
NCT06837194 — Washed Microbiota Transplantation Combined With Enteral Nutrition for Gastroptosis · recruiting

Other Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University trials

Trials by the same sponsor.

NCT07535567 — Postoperative Radiotherapy With Nimotuzumab ± Benmelstobart in Intermediate-Risk Head and Neck Squamous Cell Carcinoma: · Phase 2, PHASE3 · not yet recruiting
NCT07505251 — Development and Validation of the Periodontal Map Derived From IOS and CBCT Registration for Diagnosis and Treatment Pla · not yet recruiting
NCT07466810 — Resection and Defect Repair of Oral Cancer Aided by Mixed Reality Technology · NA · not yet recruiting
NCT07533695 — Impact of Day 2 Versus Day 3 Fresh Embryo Transfer on Live Birth Rate in Poor-Prognosis Patients · NA · not yet recruiting
NCT07490561 — The Impact of Assisted Hatching on Pregnancy Outcomes After Vitrified-Warmed Embryo Transfer in Advanced-age Patients · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03545490 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Last refreshed: 18 December 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03545490.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing