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Brief Title: 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 ID: NCT02055833
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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Nutrition and Dietetics Service, Fondazione IRCCS Policlinico San Matteo, Pavia, , Italy
Name: Emanuele Cereda, MD, PhD
Affiliation: Nutrition and Dietetics Service, Fondazione IRCCS Policlinico San Matteo
Role: PRINCIPAL_INVESTIGATOR
Name: Riccardo Caccialanza, MD
Affiliation: Nutrition and Dietetics Service, Fondazione IRCCS Policlinico San Matteo
Role: STUDY_DIRECTOR