Intensive Nutritional Counseling in Head-neck Cancer Patients Undergoing Radiotherapy

NCT02055833 | Completed DMC

• 1 other identifier: 20120001310
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 1

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.

Conditions

Head-neck Cancer

Outcome Measures

Primary Outcomes (1)

• Body weight

  Change in body weight at the end of radiotherapy (after 6 weeks)

  6 weeks

Secondary Outcomes (5)

• Body weight

  3 months

• Body weight

  5 months

• Quality of life

  5 months

• Handgrip strength

  5 months

• Phase angle

  5 months

Other Outcomes (1)

• Feasibility of radiotherapy

  6 weeks

Study Arms (2)

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)

Dietary Supplement: Intensive nutritional counseling

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)

Other: Nutritional counseling

Interventions

Intensive nutritional counseling DIETARY_SUPPLEMENT

Intensive nutritional counseling: nutritional counseling + oral nutritional supplements

Also known as: Resource Support Plus (Nestlè Health Science)

Intensive nutritional counseling

Nutritional counseling OTHER

Nutritional counseling

Nutritional counseling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• newly diagnosed head-neck cancer
• indication to radiotherapy
• Eastern Cooperative Oncology Group performance status \<=2
• availability to planned measurements and to written informed consent.

You may not qualify if:

• age \<18 years
• ongoing artificial nutrition
• refusal

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead
• Nestlè Health Science: collaborator
• Akern Srl: collaborator

Study Sites (1)

Nutrition and Dietetics Service, Fondazione IRCCS Policlinico San Matteo

Pavia, 27100, Italy

Location

Related Publications (5)

• 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.

  PMID: 23845384 BACKGROUND

• 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.

  PMID: 22345712 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.

  PMID: 16697500 BACKGROUND

• 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.

  PMID: 34130709 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.

  PMID: 29111172 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: February 4, 2014
• First Posted: February 5, 2014
• Study Start: September 1, 2013
• Primary Completion: June 1, 2016
• Study Completion: August 1, 2016
• Last Updated: May 1, 2025

Record last verified: 2016-08

Locations

IT (1)