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Trial registered on ANZCTR


Registration number
ACTRN12612000180819
Ethics application status
Approved
Date submitted
24/11/2011
Date registered
9/02/2012
Date last updated
5/03/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Nutrition intervention in (chemo)radiation for lung cancer.
Scientific title
The impact of early and intensive medical nutrition therapy on nutritional, functional, fatigue and treatment outcomes in lung cancer patients receiving (chemo)radiotherapy: a randomised controlled trial.
Secondary ID [1] 273429 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
The impact of medical nutrition therapy in (chemo)radiation for lung cancer. 279213 0
Condition category
Condition code
Cancer 279421 279421 0 0
Lung - Non small cell
Cancer 285991 285991 0 0
Lung - Small cell
Diet and Nutrition 285992 285992 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Medical nutrition therapy. This will involve indivualised one-on-one dietary counselling in person or over the phone by a dietitian once prior to starting (chemo)radiotherapy, weekly during treatment and fortnightly for 6 weeks after treatment. Each session will be between 15 to 30 minutes duration depending on the degree of nutritional issues identified. The average length of the intervention period is 14 weeks.
Intervention code [1] 283761 0
Treatment: Other
Intervention code [2] 283783 0
Lifestyle
Intervention code [3] 283784 0
Prevention
Comparator / control treatment
Usual care which consists of fortnightly one-on-one dietary counselling in person by a dietitian from week 2 of (chemo)radiation for between 15 to 30 minutes each. Following completion of (chemo)radiation participants will be reviewed in person by the dietitian at 4 weeks post treatment.
Control group
Active

Outcomes
Primary outcome [1] 285989 0
Nutritional status as measured by the Patient Generated Subjective Global Assessment.
Timepoint [1] 285989 0
At 4 weeks following completion of (chemo)radiotherapy.
Secondary outcome [1] 294905 0
Secondary outcome 1: Fat free mass as measured using foot-to-foot biolectrical impedance analysis.
Timepoint [1] 294905 0
At week 1 and final week of (chemo)radiotherapy and week 4 and 3 months following completion of (chemo)radiotherapy.
Secondary outcome [2] 294906 0
Secondary outcome 2: Functional status as measured using the Functional Assessment of Cancer Therapy - Lung questionnaire.
Timepoint [2] 294906 0
At week 1 and final week of (chemo)radiotherapy and week 4 week and 3 months following completion of (chemo)radiotherapy.
Secondary outcome [3] 294907 0
Secondary outcome 3: Fatigue as measured using the Functional Assessment of Cancer Therapy - Lung questionnaire.
Timepoint [3] 294907 0
At week 1 and final week of (chemo)radiotherapy and week 4 and 3 months following completion of (chemo)radiotherapy.

Eligibility
Key inclusion criteria
Patients undergoing radical radiotherapy with or without chemotherapy for a primary diagnosis of non-small cell or small cell lung cancer.

Patients who are over 18 years of age.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients being treated with palliative intent.

Patients receving induction chemotherapy prior to (chemo)radiation treatment.

Patients with small peripheral tumours and no mediastinal disease.

Patients having twice daily radiotherapy.

Patients who are non-English speaking.

Patients with a cognitive impairment or psychiatric illness.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation to study arm will be electronic through a randomisation database designed and build by the Biostatistics and Clinical Trial Centre at Peter MacCallum Cancer Centre. Allocation to study arm will occur following the baseline assessment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation database
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
Completed
Date of first participant enrolment
Anticipated
24/07/2012
Actual
24/07/2012
Date of last participant enrolment
Anticipated
Actual
16/07/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
84
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 284237 0
Government body
Name [1] 284237 0
Victorian Cancer Agency
Country [1] 284237 0
Australia
Primary sponsor type
Hospital
Name
Peter MacCallum Cancer Centre
Address
Department of Nursing and Supportive Care Research
Peter MacCallum Cancer Centre
Locked Bag 1, A'Beckett Street
Melbourne
Victoria 8006
Country
Australia
Secondary sponsor category [1] 269193 0
None
Name [1] 269193 0
Address [1] 269193 0
Country [1] 269193 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286202 0
Peter MacCallum Cancer Centre
Ethics committee address [1] 286202 0
Ethics committee country [1] 286202 0
Australia
Date submitted for ethics approval [1] 286202 0
10/02/2012
Approval date [1] 286202 0
Ethics approval number [1] 286202 0
12_10

Summary
Brief summary
This study aims to find out if dietary counselling before, during and after your upcoming (chemo)radiotherapy treatment helps to reduce weight loss and improve functioning and fatigue levels. It will also explore if this improves quality of life, severity of treatment symptoms, the number of unexpected admissions to hospital, interruptions to your treatment, response to cancer treatment and survival after treatment. Who is it for? You may be eligible for this study if you are over 18 years of age and due to undergo radiotherapy with or without chemotherapy for non-small cell or small cell lung cancer. Patients with lung cancer are at risk of developing side effects from (chemo)radiotherapy treatment that affect their ability to eat adequately and place them at risk of developing malnutrition. Up to 33% of patient with lung cancer may be malnourished before starting (chemo)radiotherapy and this can increase to 50% after radiotherapy is completed. Patients who are malnourished or underweight have more complications, more symptoms, poorer quality of life, more treatment interruptions, poorer response to cancer treatment and don't survive as long after treatment. Previous research has demonstrated that patients with head and neck and gastrointestinal cancer who received dietary counselling from a dietitian during and after (chemo)radiation lose less weight, have a better quality of life and functioning, and colorectal cancer patients who received dietary counselling survived longer after treatment. Providing dietary counselling from a dietitian during (chemo)radiotherapy treatment for lung cancer has never been tested. Trial Details: You will be randomised to one of two treatment arms, either a medical nutrition therapy arm or usual care. The medical nutrition therapy arm consists of individualised one-on-one dietary counselling in person or over the phone once before treatment starts, weekly during treatment and fortnightly for 6 weeks after treatment. The usual care arm will receive dietary counselling but less frequently and starting during treatment instead of before treatment. The results of this study will be incorporated into existing evidence based guidelines for the nutritional management of patients receiving radiation therapy. These guidelines are used by dietitians and other health professional to provide the best nutritional care to cancer patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33419 0
A/Prof Meinir Krishnasamy
Address 33419 0
Department of Cancer Experiences Research
Peter MacCallum Cancer Centre
Locked Bag 1, A'Beckett Street
East Melbourne, Victoria, 3002
Country 33419 0
Australia
Phone 33419 0
+61 3 9656 3783
Fax 33419 0
Email 33419 0
[email protected]
Contact person for public queries
Name 16666 0
Nicole Kiss
Address 16666 0
Department of Cancer Experiences Research, Peter MacCallum Cancer Centre Locked Bag 1, A' Beckett Street, Melbourne Victoria 8006
Country 16666 0
Australia
Phone 16666 0
+61 3 9656 3783
Fax 16666 0
Email 16666 0
[email protected]
Contact person for scientific queries
Name 7594 0
Nicole Kiss
Address 7594 0
Department of Cancer Experiences Research, Peter MacCallum Cancer Centre, Locked Bag 1, A'Beckett Street, Melbourne, Victoria 8006
Country 7594 0
Australia
Phone 7594 0
+61 3 9656 3783
Fax 7594 0
Email 7594 0
[email protected]

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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