NCT02055833

Intensive Nutritional Counseling in Head-neck Cancer Patients Undergoing Radiotherapy

Intensive Nutritional Counseling in Head-neck Cancer Patients Undergoing Radiotherapy: a Randomized, Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 159 (actual)
• Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Head-neck Cancer

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Intensive nutritional counseling	Intensive nutritional counseling: nutritional counseling + oral nutritional supplements
OTHER	Nutritional counseling	Nutritional counseling

Timeline

• Start date: 2013-09-01
• Primary completion: 2016-06-01
• Completion: 2016-08-01
• First posted: 2014-02-05
• Last updated: 2025-05-01

Locations

1 site across 1 country: Italy