Intensive Nutritional Counseling in Head-neck Cancer Patients Undergoing Radiotherapy

Not Applicable

Completed

• Conditions: Head-neck Cancer

• Registration Number: NCT02055833
• Lead Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia

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

Not available

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2014-02-04
• Study First Submitted QC: 2014-02-04
• Study First Posted: 2014-02-05
• Primary Completion: 2016-06
• Status Verified: 2016-08
• Study Completion: 2016-08
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 159

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Body weight	6 weeks	Change in body weight at the end of radiotherapy (after 6 weeks)

Secondary Outcome Measures

Name	Time	Method
Quality of life	5 months	Trends in quality of life during the study (assessment: at the end of radiotherapy; at 1 month and at 3 months since the end of radiotherapy)
Handgrip strength	5 months	Trends in handgrip strength during the study (assessment: at the end of radiotherapy; at 1 month and at 3 months since the end of radiotherapy)
Phase angle	5 months	Trends in phase angle (as surrogate of body composition) during the study (assessment: at the end of radiotherapy; at 1 month and at 3 months since the end of radiotherapy)
Body weight	5 months	Change in body weight at 3 months since the end of radiotherapy

Trial Locations

Locations (1)

Nutrition and Dietetics Service, Fondazione IRCCS Policlinico San Matteo; 🇮🇹 Pavia, Italy