Intensive Nutritional Counseling in Head-neck Cancer Patients Undergoing Radiotherapy

Conditions

Head-neck Cancer

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.

Béatrice Martin, Emanuele Cereda, Riccardo Caccialanza, Paolo Pedrazzoli, Rosanna Tarricone et al. (6 authors)

Cost Effectiveness and Resource Allocation2021-06-1521 citations

10.1186/s12962-021-00291-7

Nutritional counseling with or without systematic use of oral nutritional supplements in head and neck cancer patients undergoing radiotherapy.

Cereda E, Cappello S, Colombo S, Klersy C, Imarisio I, Turri A, Caraccia M, Borioli V, Monaco T, Benazzo M, Pedrazzoli P, Corbella F, Caccialanza R.

2017-10-27109 citations

10.1016/j.radonc.2017.10.015

Nutritional counseling with or without systematic use of oral nutritional supplements in head and neck cancer patients undergoing radiotherapy.

Paolo Pedrazzoli, Emanuele Cereda, Silvia Cappello, Sara Colombo, Catherine Klersy et al. (12 authors)

Journal of Clinical Oncology2017-05-2012 citations

10.1200/jco.2017.35.15_suppl.10098

Interventions

DIETARY_SUPPLEMENTIntensive nutritional counseling

Intensive nutritional counseling: nutritional counseling + oral nutritional supplements

OTHERNutritional counseling

Nutritional counseling

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Body weight	3 months	Change in body weight at 1 month since the end of radiotherapy
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)

Other

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

Countries

Italy

Outcome results

None listed