Intensive Nutritional Counseling in Head-neck Cancer Patients Undergoing Radiotherapy

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Completed

Conditions: Head-neck Cancer

Treatments: Dietary Supplement: Intensive nutritional counseling; Other: Nutritional counseling

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02055833

20120001310

Details and patient eligibility

About

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.

Enrollment: 159 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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159 participants in 2 patient groups

Intensive nutritional counseling

Experimental group

Description:

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)

Treatment:

Dietary Supplement: Intensive nutritional counseling

Nutritional counseling

Active Comparator group

Description:

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)

Treatment:

Other: Nutritional counseling