International Nutrition Audit in FORegut TuMors

Head and Neck Cancer Clinical Trial

— INFORM  

Official title:

International Audit of Nutrition Care in Patients With FORegut TuMors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02829489
• Other study ID #: 11111
• Status: Completed
• Start date: July 26, 2016
• Est. completion date: October 15, 2019

Study information

• Verified date: November 2019
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to evaluate the current state of nutrition care and patient related outcomes in patients with head, neck and esophageal cancers in North America, Europe and Australia.

Description:

The proposed project is a prospective inception cohort study of current nutrition practices of patients with foregut tumors (esophageal and/or head & neck cancer) in cancer care settings in Canada, Europe and Australia. This multi center study will involve a baseline audit of current nutrition practice, followed by repeated audit cycles for up to 6 months from the first time the patient is introduced to the Cancer Care System. Approximately 5-7 Cancer Care settings from Europe, Australia and North America will participate in this audit.

All consecutive consenting patients will be enrolled in the study. As an audit, a formal sample size calculation is not possible, however, we estimate that each of the 5-7 sites will be able to enroll 20 patients over 1 year, with a 6 month follow up, resulting in an estimated sample size of 140-200. All the nutrition care characteristics, patient level descriptors and patient related outcomes will be described using mean and standard deviation or median and inter quantile range based on distributional properties for continuous variables by different locations and cancer care settings. Count with percentages will be used for categorical variables. The effect of route of nutrition, timing of initiation of nutrition intervention, adequacy of nutrition, Patient Generated Subjective Global Assessment (PGSGA) scores and scores of weight, food intake, symptoms and activities & function on survival of the patients will be assessed by univariate and multi-variable Cox regression.

The association of categorical factors such as route of nutrition, timing of initiation of nutrition intervention and so on with the categorical outcomes—complications related to cancer treatment, unplanned readmission and treatment toxicity—will be assessed by chi-square or Fisher exact test, as appropriate. The continuous variables such as PGSGA and other scores will be compared between different categories of the outcomes by t-test or ANOVA as appropriate. Appropriate non-parametric test will be conducted if distributional properties invalidate the use of t-test or ANOVA. The association of continuous variables with continuous outcomes will be assessed by Pearson or Spearman correlation. If necessary, multivariable analyses will be conducted using multiple regression analysis for continuous outcomes and logistic regression for binary outcomes.

Data will be stored in REDCap system housed in a physically and electronically secure data centre at the University of Alberta and is behind the Faculty of Medicine's firewall. REDCap is a secure, web-based application designed exclusively to support data capture for research studies. REDCap provides: 1) an intuitive interface for data entry (with data validation); 2) 128 bit encryption between the data entry client and the server; 3) audit trails for tracking data manipulation and export procedures; 4) automated export procedures for seamless data downloads to common statistical packages (SPSS, Statistical Analysis Software [SAS], Stata, R); 5) procedures for importing data from external sources; and 6) advanced features, such as branching logic, calculated fields and data quality checks.

After this pilot study is completed, we hope to enhance the nutrition evidence in this area by expanding this work to create a prospective registry of nutrition practices and outcomes in patients with foregut tumors.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: October 15, 2019
• Est. primary completion date: October 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

1. Patients with Head and Neck or Esophageal Cancer and

2. At least 18 yrs age.

Exclusion Criteria:

1. At the time of diagnosis of cancer, if there is no treatment plan due to patient's imminent death OR

2. At the time of diagnosis of cancer, patient's Eastern Cooperative Oncology Score (ECOG) score is = 4

Related Conditions & MeSH terms

• Esophageal Cancer
• Head and Neck Cancer

Locations

Country	Name	City	State
Australia	Chris O Brien Lifehouse & Royal Prince Alfred Hospital	Camperdown	New South Wales
Australia	Royal Brisbane and Women's Hospital	Herston	Queensland
Canada	University of Alberta	Calgary	Alberta
Canada	University of Alberta	Edmonton	Alberta
Italy	Sapienza University	Rome
Netherlands	VU University Medical Center	Amsterdam	MB
United States	University of California, Davis Medical Center	Sacramento	California

Sponsors (4)

Lead Sponsor	Collaborator
University of Alberta	Baxter Healthcare Corporation, Fresenius Kabi, Nutricia Advanced

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Italy,  Netherlands, 

References & Publications (9)

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

Correia MI, Waitzberg DL. The impact of malnutrition on morbidity, mortality, length of hospital stay and costs evaluated through a multivariate model analysis. Clin Nutr. 2003 Jun;22(3):235-9. — View Citation

Hammerlid E, Wirblad B, Sandin C, Mercke C, Edström S, Kaasa S, Sullivan M, Westin T. Malnutrition and food intake in relation to quality of life in head and neck cancer patients. Head Neck. 1998 Sep;20(6):540-8. — View Citation

Howell D, Molloy S, Wilkinson K, Green E, Orchard K, Wang K, Liberty J. Patient-reported outcomes in routine cancer clinical practice: a scoping review of use, impact on health outcomes, and implementation factors. Ann Oncol. 2015 Sep;26(9):1846-58. doi: 10.1093/annonc/mdv181. Epub 2015 Apr 17. Review. — View Citation

Lees J. Incidence of weight loss in head and neck cancer patients on commencing radiotherapy treatment at a regional oncology centre. Eur J Cancer Care (Engl). 1999 Sep;8(3):133-6. — View Citation

Martin L, de van der Schueren MA, Blauwhoff-Buskermolen S, Baracos V, Gramlich L. Identifying the Barriers and Enablers to Nutrition Care in Head and Neck and Esophageal Cancers: An International Qualitative Study. JPEN J Parenter Enteral Nutr. 2016 Mar;40(3):355-66. doi: 10.1177/0148607114552847. Epub 2014 Oct 6. — View Citation

Rabinovitch R, Grant B, Berkey BA, Raben D, Ang KK, Fu KK, Cooper JS; Radiation Therapy Oncology Group. Impact of nutrition support on treatment outcome in patients with locally advanced head and neck squamous cell cancer treated with definitive radiotherapy: a secondary analysis of RTOG trial 90-03. Head Neck. 2006 Apr;28(4):287-96. — View Citation

Rose-Ped AM, Bellm LA, Epstein JB, Trotti A, Gwede C, Fuchs HJ. Complications of radiation therapy for head and neck cancers. The patient's perspective. Cancer Nurs. 2002 Dec;25(6):461-7; quiz 468-9. — View Citation

Van Cutsem E, Arends J. The causes and consequences of cancer-associated malnutrition. Eur J Oncol Nurs. 2005;9 Suppl 2:S51-63. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delivery of nutrition intervention	What is the timing of start of nutrition, adequacy of nutrition and the route of nutrition (oral, enteral and/or parenteral)	up to a maximum of 6 months
Secondary	Correlation of route of nutrition with outcomes	Does the route of nutrition (oral, enteral, if enteral either gastric or jejunal or parenteral) correlate with survival, complications related to cancer treatment, unplanned re-admissions, treatment tolerance and treatment toxicity	up to a maximum of 6 months
Secondary	Correlation of timing of start of nutrition with outcomes	Does the timing of initiation of nutrition intervention correlate with survival, complications related to cancer treatment, unplanned re-admissions, treatment tolerance and treatment toxicity	up to a maximum of 6 months
Secondary	Correlation of adequacy of nutrition with outcomes	Does the adequacy of nutrition intervention correlate with survival, complications related to cancer treatment, unplanned re-admissions, treatment tolerance and treatment toxicity	up to a maximum of 6 months
Secondary	Correlation of patient generated assessments with outcomes	Does the PGSGA correlate with survival, complications related to cancer treatment, unplanned re-admissions, treatment tolerance and treatment toxicity	Baseline, 2, 4 and 6 months

External Links

•   Evidence based practice guidelines for the nutritional management of adult patients with head and neck cancer. Clinical Oncology Society of Australia (COSA).