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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02829489




Registration number
NCT02829489
Ethics application status
Date submitted
7/07/2016
Date registered
12/07/2016
Date last updated
5/11/2019

Titles & IDs
Public title
International Nutrition Audit in FORegut TuMors
Scientific title
International Audit of Nutrition Care in Patients With FORegut TuMors
Secondary ID [1] 0 0
11111
Universal Trial Number (UTN)
Trial acronym
INFORM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Head and Neck Cancer 0 0
Esophageal Cancer 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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)
Timepoint [1] 0 0
up to a maximum of 6 months
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
up to a maximum of 6 months
Secondary outcome [2] 0 0
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
Timepoint [2] 0 0
up to a maximum of 6 months
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
up to a maximum of 6 months
Secondary outcome [4] 0 0
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
Timepoint [4] 0 0
Baseline, 2, 4 and 6 months

Eligibility
Key inclusion criteria
1. Patients with Head and Neck or Esophageal Cancer and

2. At least 18 yrs age.
Minimum age
19 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Chris O Brien Lifehouse & Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
4029 - Herston
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
Canada
State/province [2] 0 0
Alberta
Country [3] 0 0
Italy
State/province [3] 0 0
Rome
Country [4] 0 0
Netherlands
State/province [4] 0 0
MB

Funding & Sponsors
Primary sponsor type
Other
Name
University of Alberta
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Fresenius Kabi
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/Industry
Name [2] 0 0
Nutricia Advanced
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Commercial sector/Industry
Name [3] 0 0
Baxter Healthcare Corporation
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT02829489
Trial related presentations / publications
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.
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.
Van Cutsem E, Arends J. The causes and consequences of cancer-associated malnutrition. Eur J Oncol Nurs. 2005;9 Suppl 2:S51-63. Review.
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.
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.
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.
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.
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.
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. Review.
Public notes

Contacts
Principal investigator
Name 0 0
Leah Gramlich, MD, FRCP
Address 0 0
University of Alberta
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications