Intensive Nutritional Counseling in Head-neck Cancer Patients Undergoing Radiotherapy

August 29, 2016 updated by: Emanuele Cereda, IRCCS Policlinico S. Matteo

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

159

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Pavia, Italy, 27100
        • Nutrition and Dietetics Service, Fondazione IRCCS Policlinico San Matteo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intensive nutritional counseling
Nutritional counseling (follow-up visits once a week for 6 weeks [during radiotherapy] and at 1 month and at 3 months since the end of radiotherapy) + n-3 polyunsaturated fatty acids-enriched oral nutritional supplements (1-2 bottles/day)
Dietary supplement: Intensive nutritional counseling
Intensive nutritional counseling: nutritional counseling + oral nutritional supplements
Other Names:
  • Resource Support Plus (Nestlè Health Science)
Active Comparator: Nutritional counseling
Nutritional counseling (follow-up visits once a week for 6 weeks [during radiotherapy] and at 1 month and at 3 months since the end of radiotherapy)
Other: Nutritional counseling
Nutritional counseling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body weight
Time Frame: 6 weeks
Change in body weight at the end of radiotherapy (after 6 weeks)
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body weight
Time Frame: 3 months
Change in body weight at 1 month since the end of radiotherapy
3 months
Body weight
Time Frame: 5 months
Change in body weight at 3 months since the end of radiotherapy
5 months
Quality of life
Time Frame: 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)
5 months
Handgrip strength
Time Frame: 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)
5 months
Phase angle
Time Frame: 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)
5 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of radiotherapy
Time Frame: 6 weeks
Described as: number of interruptions >5 days; total duration (days); dose reduction
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Policlinico S. Matteo

Collaborators

Nestlé Health Science Spain
Akern Srl

Investigators

  • Principal Investigator: Emanuele Cereda, MD, PhD, Nutrition and Dietetics Service, Fondazione IRCCS Policlinico San Matteo
  • Study Director: Riccardo Caccialanza, MD, Nutrition and Dietetics Service, Fondazione IRCCS Policlinico San Matteo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

February 4, 2014

First Submitted That Met QC Criteria

February 4, 2014

First Posted (Estimate)

February 5, 2014

Study Record Updates

Last Update Posted (Estimate)

August 30, 2016

Last Update Submitted That Met QC Criteria

August 29, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20120001310

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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