International Nutrition Audit in FORegut TuMors

NCT02829489 | Completed

• 1 other identifier: 11111
• Study Type: observational
• Target: 170
• Locations: 5 countries
• Sites: 7

Brief 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.

Conditions

Head and Neck Cancer; Esophageal Cancer

Keywords

nutrition; foregut tumors; patient related outcomes; audit

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Correlation of route of nutrition with outcomes

  up to a maximum of 6 months

• Correlation of timing of start of nutrition with outcomes

  up to a maximum of 6 months

• Correlation of adequacy of nutrition with outcomes

  up to a maximum of 6 months

• Correlation of patient generated assessments with outcomes

  Baseline, 2, 4 and 6 months

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with head and/or neck cancer or esophageal cancer

You may qualify if:

• Patients with Head and Neck or Esophageal Cancer and
• At least 18 yrs age.

You may not qualify if:

• At the time of diagnosis of cancer, if there is no treatment plan due to patient's imminent death OR
• At the time of diagnosis of cancer, patient's Eastern Cooperative Oncology Score (ECOG) score is ≥ 4

Sponsors & Collaborators

• University of Alberta: lead
• Fresenius Kabi: collaborator
• Nutricia Advanced: collaborator
• Baxter Healthcare Corporation: collaborator

Study Sites (7)

University of California, Davis Medical Center

Sacramento, California, 95817, United States

Location

Chris O Brien Lifehouse & Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

Location

Royal Brisbane and Women's Hospital

Herston, Queensland, 4029, Australia

Location

University of Alberta

Calgary, Alberta, T2P3B6, Canada

Location

University of Alberta

Edmonton, Alberta, T5H 3V9, Canada

Location

Sapienza University

Rome, Italy

Location

VU University Medical Center

Amsterdam, MB, 1007, Netherlands

Location

Related Publications (9)

• 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. doi: 10.1046/j.1365-2354.1999.00156.x.

  PMID: 10763643 BACKGROUND

• Hammerlid E, Wirblad B, Sandin C, Mercke C, Edstrom 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. doi: 10.1002/(sici)1097-0347(199809)20:63.0.co;2-j.

  PMID: 9702542 BACKGROUND

• Van Cutsem E, Arends J. The causes and consequences of cancer-associated malnutrition. Eur J Oncol Nurs. 2005;9 Suppl 2:S51-63. doi: 10.1016/j.ejon.2005.09.007.

  PMID: 16437758 BACKGROUND

• 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. doi: 10.1016/s0261-5614(02)00215-7.

  PMID: 12765661 BACKGROUND

• 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. doi: 10.1002/hed.20335.

  PMID: 16287132 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 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.

  PMID: 25288589 BACKGROUND

• 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. doi: 10.1097/00002820-200212000-00010.

  PMID: 12464838 BACKGROUND

• 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):1846-1858. doi: 10.1093/annonc/mdv181. Epub 2015 Apr 17.

  PMID: 25888610 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Head and Neck Neoplasms; Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Leah Gramlich, MD, FRCP

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2016
• First Posted: July 12, 2016
• Study Start: July 26, 2016
• Primary Completion: October 15, 2019
• Study Completion: October 15, 2019
• Last Updated: November 5, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: December 2018
• Access Criteria: In accordance with the Data Sharing Agreements and contracts with each researcher

Locations

US (1); AU (2); CA (2); IT (1); NL (1)