Clinical trial · Interventional
Effect of Oral Supplements on the Nutritional Status of Locally Advanced Nasopharyngeal Carcinoma Patients
A Randomized Phase II Trial to Assess the Effect of Oral Supplements on the Nutritional Status of Locally Advanced Nasopharyngeal Carcinoma Patients During Concurrent Chemotherapy
- 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)
Malnutrition is very common in locally advanced nasopharyngeal carcinoma(NPC) patients undergoing current chemoradiotherapy (CRT) due to dysphagia, mucositis, nausea and other treatment-related problems. Malnutrition is associated with lower physical functioning, lower immune status, more severe (grade III/IV) late RT-induced toxicities, treatment interruption of chemo(radio)therapy, lower chemotherapy response rates, hospital readmission, impaired quality of life (QoL), and increased mortality. Although the international guidelines recommend early nutritional support in the presence of nutritional risk, the best type of nutritional intervention is still unclear. Individualized dietary counseling showed beneficial effects in nutritional intake, nutritional status and QoL in head and neck cancer patients undergoing RT or CRT-treatment; oral nutritional supplements (ONS) was most acceptable in Chinese NPC patients. Previous nutritional intervention trials in head-neck cancer patients have been conducted on small samples and did not clarify the role of oral nutritional supplements (ONS). Accordingly, although current guidelines recommend as grade A the use of ONS associated with dietary counseling for head-neck cancer patients undergoing RT, the efficacy of this nutritional intervention still needs to be evaluated in adequately sized and randomized clinical trials for Chinese NPC patients.
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 |
|---|---|---|---|
| Nasopharyngeal Carcinoma | Nasopharyngeal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Healing Elements,Methuselah Medical Technology | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ONS group
- description
- Individualized dietary counseling+ONS(Healing elements)during CRT Interventions: (Healing elements)
- interventionNames
- Dietary Supplement: Healing Elements,Methuselah Medical Technology
- type
- NO_INTERVENTION
- label
- control group
- description
- Individualized dietary counseling during CRT
Primary outcomes (1)
- measure
- Body weight(kg)change during concurrent chemotherapy
- timeFrame
- every week during the course of radiotherapy, up to 6-7 weeks
Secondary outcomes (11)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Newly diagnosed、pathologically proven nasopharyngeal carcinoma(Stage III/IV) 2. Concurrent radiation and chemotherapy(platinum ) 3. Karnofsky score over 60 4. No evidence of metastatic disease 5. No significant cardiac, chest, gastrointestinal or renal morbidities Exclusion Criteria: 1. age \<18 years 2. ongoing artificial nutrition 3. refusal
References
Publications (0)
Data not yet available