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Intensive Nutritional Counseling in Head-neck Cancer Patients Undergoing Radiotherapy

NCT02055833 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 159

Last updated 2025-05-01

No results posted yet for this study

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

DIETARY_SUPPLEMENT

Intensive nutritional counseling

Intensive nutritional counseling: nutritional counseling + oral nutritional supplements

OTHER

Nutritional counseling

Nutritional counseling

Sponsors & Collaborators

  • Nestlè Health Science

    collaborator UNKNOWN

  • Akern Srl

    collaborator INDUSTRY

  • Fondazione IRCCS Policlinico San Matteo di Pavia

    lead OTHER

Principal Investigators

  • Emanuele Cereda, MD, PhD · Nutrition and Dietetics Service, Fondazione IRCCS Policlinico San Matteo

  • Riccardo Caccialanza, MD · Nutrition and Dietetics Service, Fondazione IRCCS Policlinico San Matteo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2016-06-30
Completion
2016-08-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02055833 on ClinicalTrials.gov