Intensive Nutritional Counseling in Head-neck Cancer Patients Undergoing Radiotherapy
Conditions
Head-neck Cancer
Conditions: official terms
Head and Neck Neoplasms
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Intensive nutritional counseling Type: Dietary Supplement
Name: Nutritional counseling Type: Other
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
Location
Nutrition and Dietetics Service, Fondazione IRCCS Policlinico San Matteo
Pavia, Italy
Status: Recruiting
Contact: Emanuele Cereda, MD, PhD - 00390382501615 - e.cereda@smatteo.pv.it
Start Date
September 2013
Completion Date
September 2016
Sponsors
IRCCS Policlinico S. Matteo
Source
IRCCS Policlinico S. Matteo
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page