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| Name | Class |
|---|---|
| Nestle Health Science | INDUSTRY |
| Akern Srl | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intensive nutritional counseling | Experimental | 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) |
|
| Nutritional counseling | Active Comparator | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensive nutritional counseling | Dietary Supplement | Intensive nutritional counseling: nutritional counseling + oral nutritional supplements |
|
| Measure | Description | Time Frame |
|---|---|---|
| Body weight | Change in body weight at the end of radiotherapy (after 6 weeks) | 6 weeks |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of radiotherapy | Described as: number of interruptions >5 days; total duration (days); dose reduction | 6 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emanuele Cereda, MD, PhD | Nutrition and Dietetics Service, Fondazione IRCCS Policlinico San Matteo | Principal Investigator |
| Riccardo Caccialanza, MD | Nutrition and Dietetics Service, Fondazione IRCCS Policlinico San Matteo | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nutrition and Dietetics Service, Fondazione IRCCS Policlinico San Matteo | Pavia | 27100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23845384 | Background | Langius JA, Zandbergen MC, Eerenstein SE, van Tulder MW, Leemans CR, Kramer MH, Weijs PJ. Effect of nutritional interventions on nutritional status, quality of life and mortality in patients with head and neck cancer receiving (chemo)radiotherapy: a systematic review. Clin Nutr. 2013 Oct;32(5):671-8. doi: 10.1016/j.clnu.2013.06.012. Epub 2013 Jun 26. | |
| 22345712 |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D015596 | Nutrition Assessment |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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|
| Nutritional counseling | Other | Nutritional counseling |
|
| 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 |
| Baldwin C, Spiro A, Ahern R, Emery PW. Oral nutritional interventions in malnourished patients with cancer: a systematic review and meta-analysis. J Natl Cancer Inst. 2012 Mar 7;104(5):371-85. doi: 10.1093/jnci/djr556. Epub 2012 Feb 15. |
| 16697500 | Background | Arends J, Bodoky G, Bozzetti F, Fearon K, Muscaritoli M, Selga G, van Bokhorst-de van der Schueren MA, von Meyenfeldt M; DGEM (German Society for Nutritional Medicine); Zurcher G, Fietkau R, Aulbert E, Frick B, Holm M, Kneba M, Mestrom HJ, Zander A; ESPEN (European Society for Parenteral and Enteral Nutrition). ESPEN Guidelines on Enteral Nutrition: Non-surgical oncology. Clin Nutr. 2006 Apr;25(2):245-59. doi: 10.1016/j.clnu.2006.01.020. Epub 2006 May 12. |
| 34130709 | Derived | Martin B, Cereda E, Caccialanza R, Pedrazzoli P, Tarricone R, Ciani O. Cost-effectiveness analysis of oral nutritional supplements with nutritional counselling in head and neck cancer patients undergoing radiotherapy. Cost Eff Resour Alloc. 2021 Jun 15;19(1):35. doi: 10.1186/s12962-021-00291-7. |
| 29111172 | Derived | 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. Nutritional counseling with or without systematic use of oral nutritional supplements in head and neck cancer patients undergoing radiotherapy. Radiother Oncol. 2018 Jan;126(1):81-88. doi: 10.1016/j.radonc.2017.10.015. Epub 2017 Oct 27. |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |