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Trial registered on ANZCTR


Registration number
ACTRN12612000579897
Ethics application status
Approved
Date submitted
22/05/2012
Date registered
29/05/2012
Date last updated
24/01/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Early tube feeding in head and neck cancer
Scientific title
A randomized comparison of early prophylactic feeding via gastrostomy versus standard care in high risk patients with head and neck cancer to determine impact on nutrition outcomes, quality of life and clinical outcomes
Secondary ID [1] 280533 0
Nil
Universal Trial Number (UTN)
U1111-1131-0924
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Head and neck cancer 286527 0
Malnutrition 286578 0
Condition category
Condition code
Cancer 286793 286793 0 0
Head and neck
Diet and Nutrition 286794 286794 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients randomised to the intervention will commence two supplementary bolus feeds (standard enteral formula 1.5kcal/ml with fibre) per day in addition to usual dietary intake at the time of gastrostomy placement.

The supplementary feeds will continue pre treatment and throughout treatment. Most patients will be anticipated to be receiving chemoradiotherapy with a duration of 7 weeks. Tube placement is usually within 1-2 weeks prior to chemoradiotherapy, and so total predicted duration of intervention is 8-9 weeks.

Additional feeds will be commenced as clinically indicated during treatment by the clinical dietitian.
Intervention code [1] 284908 0
Treatment: Other
Intervention code [2] 284964 0
Prevention
Comparator / control treatment
Patients randomised to standard care will commence water flushes via the gastrostomy at the time of gastrostomy placement and throughout treatment. Feeds will be commenced as clinically indicated throughout treatment as per current standard care.
Control group
Active

Outcomes
Primary outcome [1] 287164 0
Weight (to calculate % weight loss over time)
Timepoint [1] 287164 0
baseline, 3 months post completion of primary treatment for head and neck cancer
Secondary outcome [1] 297527 0
Body composition (BIA to measure fat free mass)
Timepoint [1] 297527 0
baseline and 3 months post completion of primary treatment for head and neck cancer
Secondary outcome [2] 297528 0
Nutritional status (Patient generated subjective global assessment)
Timepoint [2] 297528 0
baseline and 3 months post completion of primary treatment for head and neck cancer
Secondary outcome [3] 297529 0
Quality of life (EORTC QLQ-C30, EORTC H&N35)
Timepoint [3] 297529 0
baseline and 3 months post completion of primary treatment for head and neck cancer

Eligibility
Key inclusion criteria
Diagnosed with head and neck cancer
AND
Referred for prophylactic gastrostomy prior to treatment
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
patients with severe malnutrition at diagnosis
OR
patients with moderate malnutrition and severe dysphagia at diagnosis (requiring puree/liquid diets)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patient identified by medical oncologist at pre treatment clinic and referred to research dietitian to determine final eligibility based on nutritional assessment. Research dietitian to complete recruitment and consent. Patient will then be randomised by independent researcher team member not involved with the intervention or data collection.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation method using computer generated random sequence numbers. Patients will also be stratified according to nutritional status.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
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)
QLD
Recruitment hospital [1] 479 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 6227 0
4029 - Royal Brisbane Hospital

Funding & Sponsors
Funding source category [1] 285292 0
Hospital
Name [1] 285292 0
Royal Brisbane and Women's Hospital
Address [1] 285292 0
Butterfield Street
Herston
QLD
4029
Country [1] 285292 0
Australia
Primary sponsor type
Individual
Name
Teresa Brown
Address
Dept Nutrition and Dietetics, RBWH
Level 2 James Mayne Building
Butterfield Street
Herston
QLD
4029
Country
Australia
Secondary sponsor category [1] 284151 0
Individual
Name [1] 284151 0
Judith Bauer
Address [1] 284151 0
School of Human Movement Studies
University of Queensland
St Lucia
QLD
4072
Country [1] 284151 0
Australia
Secondary sponsor category [2] 284152 0
Individual
Name [2] 284152 0
Merrilyn Banks
Address [2] 284152 0
Dept Nutrition and Dietetics, RBWH
Level 2 James Mayne Building
Butterfield Street
Herston
QLD
4029
Country [2] 284152 0
Australia
Secondary sponsor category [3] 284153 0
Individual
Name [3] 284153 0
Brett Hughes
Address [3] 284153 0
Cancer Care Services, RBWH
Level 5 Joyce Twedell Building
Butterfield Street
Herston
QLD
4029
Country [3] 284153 0
Australia
Other collaborator category [1] 260810 0
Individual
Name [1] 260810 0
Liz Kenny
Address [1] 260810 0
Cancer Care Services, RBWH
Level 5 Joyce Twedell Building
Butterfield Street
Herston
QLD
4029
Country [1] 260810 0
Australia
Other collaborator category [2] 260811 0
Individual
Name [2] 260811 0
Charles Lin
Address [2] 260811 0
Cancer Care Services, RBWH
Level 5 Joyce Twedell Building
Butterfield Street
Herston
QLD
4029
Country [2] 260811 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287305 0
Royal Brisbane and Womens Hospital
Ethics committee address [1] 287305 0
Butterfield Street
Herston
QLD
4029
Ethics committee country [1] 287305 0
Australia
Date submitted for ethics approval [1] 287305 0
29/05/2012
Approval date [1] 287305 0
Ethics approval number [1] 287305 0
HREC/12/QRBW/162
Ethics committee name [2] 288695 0
The University of Queensland
Ethics committee address [2] 288695 0
Cumbrae-Stewart Building
Research Road
Brisbane
QLD 4072
Ethics committee country [2] 288695 0
Australia
Date submitted for ethics approval [2] 288695 0
Approval date [2] 288695 0
Ethics approval number [2] 288695 0
2012000890

Summary
Brief summary
This study aims to compare the outcome of early tube feeding compared to commencement of feeding as per current standard practice in patients undergoing gastrostomy prior to treatment for head and neck cancer.

Who is it for? You may be eligible to join this study if you are aged 18 years or above, have been diagnosed with head and neck cancer, and have been referred for a preventive gastrostomy (insertion of feeding tube into the stomach) prior to treatment for your cancer.

Trial details Participants in this trial will be randomly (by chance) allocated to one of two treatment groups. Participants in one group will commence two supplementary feeds per day at the time of feeding tube insertion (gastrostomy). These feeds will be in addition to the patient's usual dietary intake and will continue throughout cancer treatment. Participants in the other group will receive standard care. This involves water flushes via the gastrostomy throughout cancer treatment and feeds will be commenced by the dietitian as clinically indicated during treatment.

Participants will be assessed at baseline and 3 months post completion of treatment in order to determine impact on nutrition outcomes, quality of life and clinical outcomes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34210 0
Ms Teresa Brown
Address 34210 0
Nutrition & Dietetics
Level 2 James Mayne Buidling
Royal Brisbane & Womens Hospital
Butterfield Street, Herston
Qld 4029
Country 34210 0
Australia
Phone 34210 0
+61 7 36467997
Fax 34210 0
Email 34210 0
teresa_brown@health.qld.gov.au
Contact person for public queries
Name 17457 0
Ms Teresa Brown
Address 17457 0
Dept Nutrition and Dietetics
Level 2 James Mayne Building, RBWH
Butterfield Street
Herston
QLD
4029
Country 17457 0
Australia
Phone 17457 0
+617 3646 7997
Fax 17457 0
+617 3646 1874
Email 17457 0
teresa_brown@health.qld.gov.au
Contact person for scientific queries
Name 8385 0
Ms Teresa Brown
Address 8385 0
Dept Nutrition and Dietetics
Level 2 James Mayne Building, RBWH
Butterfield Street
Herston
QLD
4029
Country 8385 0
Australia
Phone 8385 0
+617 3646 7997
Fax 8385 0
+617 3646 1874
Email 8385 0
teresa_brown@health.qld.gov.au

No information has been provided regarding IPD availability
Summary results
No Results