Clinical trial · Interventional
Early Enteral Nutritional Supplementation on Patients With Oral and Oropharyngeal Cancer Undergoing Radio(Chemo)Therapy After Surgical
A Prospective, Randomized, Clinical Study to Evaluate the Effects of Early Enteral Nutritional Supplementation on Clinical Outcomes in Patients With Oral and Oropharyngeal Cancer Undergoing Radio(Chemo)Therapy After Surgical Resection
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malnutrition | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Early nutritional intervention | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Cohort 1-intervention
- description
- Oral supplements are given through oral route 2 weeks before radiotherapy.
- interventionNames
- Dietary Supplement: Early nutritional intervention
- type
- ACTIVE_COMPARATOR
- label
- Cohort 1-Control
- description
- Oral supplements are given through oral route on demand during radiotherapy.
- interventionNames
- Dietary Supplement: Early nutritional intervention
- type
- EXPERIMENTAL
- label
- Cohort 2- Intervention
- description
- Oral supplements are given by tube feeding 2 weeks before radiotherapy.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion criteria * Subject is male or female, between 18 and 70 years old; * Subject has clinical or radiological diagnosis of oral cancer (stage III and stage IV), had surgical resection 3 or 4 weeks prior to radio (chemo)therapy, and plans to receive radio (chemo)therapy treatment; * Subject has Karnofsky Performance Score (KPS) ≥ 60 and an expected life expectancy ≥ 6 months; * Subject is willing to comply with the study protocol, able and willing to consume study product according to the protocol; * Subject has voluntarily signed and dated the informed consent form (ICF), approved by an Institutional Review Board (IRB) / Independent Ethics Committee (IEC) prior to any participation in the study Exclusion criteria * Except for oral cancer and oropharyngeal cancer, subject has malignant tumors or serious infectious diseases, such as tuberculosis activity, respiratory system, cardiovascular system, urinary system diseases, systemic edema and ascites caused by diseases, etc., cannot participant in study in the opinion of study physician. * Subject has dysfunction of liver, kidney or gallbladder, cannot participant in study in the opinion of study physician. * Subject has gastrointestinal diseases to cannot tolerate enteral nutrition (such as intestinal bleeding, intestinal obstruction, severe digestive malabsorption, severe nausea and vomiting and diarrhea) that preclude his or her participation in the opinion of study physician; * Subject has diabetes * Subject has known history of allergy or intolerance to any ingredient in the investigational product; * Female subjects are pregnant or plan to get pregnant within a year or are postpartum and non-lactating; * Subject has mental illness, cannot understand ICF, unwilling to provide informed consent. * Subject has amputation or implanted electronic devices or metal, it may be inappropriate to use BIA to measure body composition * Subject is currently or has participated in any clinical trial 2 months prior to enrollment. * Subject plans to take nutritional supplements and/or traditional Chinese medicine regularly during study in the opinion of study physician. Multi-vitamin and multi-mineral supplements are exception.
References
Publications (1)
- DERIVEDJiang W, Zhang H, Dou S, He Y, Zhu G, Li R. 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. J Am Nutr Assoc. 2025 Aug;44(6):498-507. doi: 10.1080/27697061.2025.2458277. Epub 2025 Feb 4. PMID 39903480