Clinical trial · Interventional
Intensive Nutritional Counseling in Head-neck Cancer Patients Undergoing Radiotherapy
Intensive Nutritional Counseling in Head-neck Cancer Patients Undergoing Radiotherapy: a Randomized, Controlled Trial
- 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)
In head-neck cancer patients undergoing radiotherapy (RT) malnutrition is associated with impaired quality of life, reduced survival, more frequent treatment interruptions and dose reductions. The international guidelines recommend early nutritional support in the presence of nutritional risk, as it allows preventing or treating malnutrition and improving the clinical outcomes, as well as the tolerability of oncologic treatments. 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.
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 |
|---|---|---|---|
| Head-neck Cancer | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intensive nutritional counseling | Dietary Supplement | — | UNRESOLVED |
| Nutritional counseling | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intensive nutritional counseling
- description
- Nutritional counseling (follow-up visits once a week for 6 weeks \[during radiotherapy\] and at 1 month and at 3 months since the end of radiotherapy) + n-3 polyunsaturated fatty acids-enriched oral nutritional supplements (1-2 bottles/day)
- interventionNames
- Dietary Supplement: Intensive nutritional counseling
- type
- ACTIVE_COMPARATOR
- label
- Nutritional counseling
- description
- Nutritional counseling (follow-up visits once a week for 6 weeks \[during radiotherapy\] and at 1 month and at 3 months since the end of radiotherapy)
- interventionNames
- Other: Nutritional counseling
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * newly diagnosed head-neck cancer * indication to radiotherapy * Eastern Cooperative Oncology Group performance status \<=2 * availability to planned measurements and to written informed consent. Exclusion Criteria: * age \<18 years * ongoing artificial nutrition * refusal
References
Publications (5)
- BACKGROUNDLangius JA, Zandbergen MC, Eerenstein SE, van Tulder MW, Leemans CR, Kramer MH, Weijs PJ. Effect of nutritional interventions on nutritional status, quality of life and mortality in patients with head and neck cancer receiving (chemo)radiotherapy: a systematic review. Clin Nutr. 2013 Oct;32(5):671-8. doi: 10.1016/j.clnu.2013.06.012. Epub 2013 Jun 26. PMID 23845384
- BACKGROUNDBaldwin C, Spiro A, Ahern R, Emery PW. Oral nutritional interventions in malnourished patients with cancer: a systematic review and meta-analysis. J Natl Cancer Inst. 2012 Mar 7;104(5):371-85. doi: 10.1093/jnci/djr556. Epub 2012 Feb 15. PMID 22345712
- BACKGROUNDArends J, Bodoky G, Bozzetti F, Fearon K, Muscaritoli M, Selga G, van Bokhorst-de van der Schueren MA, von Meyenfeldt M; DGEM (German Society for Nutritional Medicine); Zurcher G, Fietkau R, Aulbert E, Frick B, Holm M, Kneba M, Mestrom HJ, Zander A; ESPEN (European Society for Parenteral and Enteral Nutrition). ESPEN Guidelines on Enteral Nutrition: Non-surgical oncology. Clin Nutr. 2006 Apr;25(2):245-59. doi: 10.1016/j.clnu.2006.01.020. Epub 2006 May 12. PMID 16697500
- DERIVEDMartin B, Cereda E, Caccialanza R, Pedrazzoli P, Tarricone R, Ciani O. Cost-effectiveness analysis of oral nutritional supplements with nutritional counselling in head and neck cancer patients undergoing radiotherapy. Cost Eff Resour Alloc. 2021 Jun 15;19(1):35. doi: 10.1186/s12962-021-00291-7. PMID 34130709
- DERIVEDCereda E, Cappello S, Colombo S, Klersy C, Imarisio I, Turri A, Caraccia M, Borioli V, Monaco T, Benazzo M, Pedrazzoli P, Corbella F, Caccialanza R. Nutritional counseling with or without systematic use of oral nutritional supplements in head and neck cancer patients undergoing radiotherapy. Radiother Oncol. 2018 Jan;126(1):81-88. doi: 10.1016/j.radonc.2017.10.015. Epub 2017 Oct 27. PMID 29111172