Intensive Nutritional Counseling in Head-neck Cancer Patients Undergoing Radiotherapy

Study Overview
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Brief Summary
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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.

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

Conditions
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Head-neck Cancer

Intervention / Treatment
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* Dietary Supplement: Intensive nutritional counseling
* Other: Nutritional counseling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intensive nutritional counseling<br>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<br>* Intensive nutritional counseling: nutritional counseling + oral nutritional supplements<br>* Other names: Resource Support Plus (Nestlè Health Science);|
| Active Comparator: Nutritional counseling<br>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<br>* Nutritional counseling<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight | 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 | Change in body weight at 1 month since the end of radiotherapy | 3 months | 
| Body weight | Change in body weight at 3 months since the end of radiotherapy | 5 months | 
| Quality of life | 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 | 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 | 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 |