Clinical trial NCT02055833: Intensive Nutritional Counseling in Head-neck Cancer Patients Undergoing Radiotherapy
Official title: Intensive Nutritional Counseling in Head-neck Cancer Patients Undergoing Radiotherapy: a Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head-neck Cancer
Lead sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Sponsor class: OTHER
Collaborators: name: Nestlè Health Science
name: Akern Srl
First posted: 2014-02-05
Enrollment: 159
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Body weight
timeFrame: 6 weeks
Secondary outcomes:
measure: Body weight
timeFrame: 3 months
measure: Body weight
timeFrame: 5 months
measure: Quality of life
timeFrame: 5 months
measure: Handgrip strength
timeFrame: 5 months
measure: Phase angle
timeFrame: 5 months
Other outcomes:
measure: Feasibility of radiotherapy
timeFrame: 6 weeks
Locations:
city: Pavia
country: Italy
facility: Nutrition and Dietetics Service, Fondazione IRCCS Policlinico San Matteo
Study officials:
affiliation: Nutrition and Dietetics Service, Fondazione IRCCS Policlinico San Matteo
name: Emanuele Cereda, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nutrition and Dietetics Service, Fondazione IRCCS Policlinico San Matteo
name: Riccardo Caccialanza, MD
role: STUDY_DIRECTOR
References:
citation: Langius 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.
citation: Baldwin 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.
citation: Arends 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.
citation: Martin 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.
citation: Cereda 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.