Head-neck Cancer Clinical Trial
Official title:
Intensive Nutritional Counseling in Head-neck Cancer Patients Undergoing Radiotherapy: a Randomized, Controlled Trial
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment