Intensive Nutritional Counseling in Head-neck Cancer Patients Undergoing Radiotherapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

159 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2016-08-31

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.

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Detailed Description

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Conditions

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Head-neck Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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)

Group Type EXPERIMENTAL

Intensive nutritional counseling

Intervention Type DIETARY_SUPPLEMENT

Intensive nutritional counseling: nutritional counseling + oral nutritional supplements

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)

Group Type ACTIVE_COMPARATOR

Nutritional counseling

Intervention Type OTHER

Nutritional counseling

Interventions

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Intensive nutritional counseling

Intensive nutritional counseling: nutritional counseling + oral nutritional supplements

Intervention Type DIETARY_SUPPLEMENT

Nutritional counseling

Intervention Type OTHER

Other Intervention Names

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Resource Support Plus (Nestlè Health Science)

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.