ANZCTR - Registration

The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.

With activity expected to increase on the ANZCTR again, there may be extended wait times while we process pending studies, with priority being given to those trials submitted in February. Thank you for your patience.

Reset your password and enable multi-factor authentication (MFA)

For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.

Go to the Login page, click ‘reset password’ and follow the instructions.
Check your email for the link to set a new password.
Create a new password that meets requirements.
Return to the Login page and enter your new password. A verification code will be sent to your email.
Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

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

Malnutrition

Condition category

Condition code

Cancer

Head and neck

Diet and Nutrition

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]

Treatment: Other

Intervention code [2]

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]

Weight (to calculate % weight loss over time)

Timepoint [1]

baseline, 3 months post completion of primary treatment for head and neck cancer

Secondary outcome [1]

Body composition (BIA to measure fat free mass)

Timepoint [1]

baseline and 3 months post completion of primary treatment for head and neck cancer

Secondary outcome [2]

Nutritional status (Patient generated subjective global assessment)

Timepoint [2]

baseline and 3 months post completion of primary treatment for head and neck cancer

Secondary outcome [3]

Quality of life (EORTC QLQ-C30, EORTC H&N35)

Timepoint [3]

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

Sex

Both males and females

Can healthy volunteers participate?

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

1/07/2012

Actual

19/09/2012

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

123

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

Royal Brisbane & Womens Hospital - Herston

Recruitment postcode(s) [1]

4029 - Royal Brisbane Hospital

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Royal Brisbane and Women's Hospital

Address [1]

Butterfield Street Herston QLD 4029

Country [1]

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]

Individual

Name [1]

Judith Bauer

Address [1]

School of Human Movement Studies University of Queensland St Lucia QLD 4072

Country [1]

Australia

Secondary sponsor category [2]

Individual

Name [2]

Merrilyn Banks

Address [2]

Dept Nutrition and Dietetics, RBWH Level 2 James Mayne Building Butterfield Street Herston QLD 4029

Country [2]

Australia

Secondary sponsor category [3]

Individual

Name [3]

Brett Hughes

Address [3]

Cancer Care Services, RBWH Level 5 Joyce Twedell Building Butterfield Street Herston QLD 4029

Country [3]

Australia

Other collaborator category [1]

Individual

Name [1]

Liz Kenny

Address [1]

Cancer Care Services, RBWH Level 5 Joyce Twedell Building Butterfield Street Herston QLD 4029

Country [1]

Australia

Other collaborator category [2]

Individual

Name [2]

Charles Lin

Address [2]

Cancer Care Services, RBWH Level 5 Joyce Twedell Building Butterfield Street Herston QLD 4029

Country [2]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Brisbane and Womens Hospital

Ethics committee address [1]

Butterfield Street
Herston
QLD
4029

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

29/05/2012

Approval date [1]

Ethics approval number [1]

HREC/12/QRBW/162

Ethics committee name [2]

The University of Queensland

Ethics committee address [2]

Cumbrae-Stewart Building
Research Road
Brisbane
QLD 4072

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

Ethics approval number [2]

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

Ms Teresa Brown

Address

Nutrition & Dietetics Level 2 James Mayne Buidling Royal Brisbane & Womens Hospital Butterfield Street, Herston Qld 4029

Country

Australia

Phone

+61 7 36467997

Fax

[email protected]

Contact person for public queries

Name

Teresa Brown

Address

Dept Nutrition and Dietetics Level 2 James Mayne Building, RBWH Butterfield Street Herston QLD 4029

Country

Australia

Phone

+617 3646 7997

Fax

+617 3646 1874

[email protected]

Contact person for scientific queries

Name

Teresa Brown

Address

Dept Nutrition and Dietetics Level 2 James Mayne Building, RBWH Butterfield Street Herston QLD 4029

Country

Australia

Phone

+617 3646 7997

Fax

+617 3646 1874

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Impact of early prophylactic feeding on long term tube dependency outcomes in patients with head and neck cancer.	2017	https://dx.doi.org/10.1016/j.oraloncology.2017.06.025
Embase	Randomised controlled trial of early prophylactic feeding vs standard care in patients with head and neck cancer.	2017	https://dx.doi.org/10.1038/bjc.2017.138
Embase	Tube feeding during treatment for head and neck cancer - Adherence and patient reported barriers.	2017	https://dx.doi.org/10.1016/j.oraloncology.2017.07.017
Embase	Impact of sarcopenia and myosteatosis on survival outcomes for patients with head and neck cancer undergoing curative-intent treatment.	2023	https://dx.doi.org/10.1017/S0007114522000435

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically