Head-neck Cancer Clinical Trial
Official title:
Intensive Nutritional Counseling in Head-neck Cancer Patients Undergoing Radiotherapy: a Randomized, Controlled Trial
| Verified date | August 2016 |
| Source | IRCCS Policlinico S. Matteo |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Italy: Ethics Committee |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 159 |
| Est. completion date | August 2016 |
| Est. primary completion date | June 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Italy | Nutrition and Dietetics Service, Fondazione IRCCS Policlinico San Matteo | Pavia |
| Lead Sponsor | Collaborator |
|---|---|
| IRCCS Policlinico S. Matteo | Akern Srl, Nestlé Health Science Spain |
Italy,
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), Zürcher 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. Epub 2006 May 12. — View Citation
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. Review. — View Citation
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. Review. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Feasibility of radiotherapy | Described as: number of interruptions >5 days; total duration (days); dose reduction | 6 weeks | No |
| Primary | Body weight | Change in body weight at the end of radiotherapy (after 6 weeks) | 6 weeks | No |
| Secondary | Body weight | Change in body weight at 1 month since the end of radiotherapy | 3 months | No |
| Secondary | Body weight | Change in body weight at 3 months since the end of radiotherapy | 5 months | No |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |