ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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

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]

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.

Condition category

Condition code

Cancer

Lung - Non small cell

Cancer

Lung - Small cell

Diet and Nutrition

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]

Treatment: Other

Intervention code [2]

Lifestyle

Intervention code [3]

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]

Nutritional status as measured by the Patient Generated Subjective Global Assessment.

Timepoint [1]

At 4 weeks following completion of (chemo)radiotherapy.

Secondary outcome [1]

Secondary outcome 1: Fat free mass as measured using foot-to-foot biolectrical impedance analysis.

Timepoint [1]

At week 1 and final week of (chemo)radiotherapy and week 4 and 3 months following completion of (chemo)radiotherapy.

Secondary outcome [2]

Secondary outcome 2: Functional status as measured using the Functional Assessment of Cancer Therapy - Lung questionnaire.

Timepoint [2]

At week 1 and final week of (chemo)radiotherapy and week 4 week and 3 months following completion of (chemo)radiotherapy.

Secondary outcome [3]

Secondary outcome 3: Fatigue as measured using the Functional Assessment of Cancer Therapy - Lung questionnaire.

Timepoint [3]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Victorian Cancer Agency

Address [1]

12 Victoria Street
Carlton
Melbourne
Victoria 3053

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Peter MacCallum Cancer Centre

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

10/02/2012

Approval date [1]

Ethics approval number [1]

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

A/Prof Meinir Krishnasamy

Address

Department of Cancer Experiences Research
Peter MacCallum Cancer Centre
Locked Bag 1, A'Beckett Street
East Melbourne, Victoria, 3002

Country

Australia

Phone

+61 3 9656 3783

Fax

meinir.krishnasamy@petermac.org

Contact person for public queries

Name

Nicole Kiss

Address

Department of Cancer Experiences Research, Peter MacCallum Cancer Centre Locked Bag 1, A' Beckett Street, Melbourne Victoria 8006

Country

Australia

Phone

+61 3 9656 3783

Fax

nicole.kiss@petermac.org

Contact person for scientific queries

Name

Nicole Kiss

Address

Department of Cancer Experiences Research, Peter MacCallum Cancer Centre, Locked Bag 1, A'Beckett Street, Melbourne, Victoria 8006

Country

Australia

Phone

+61 3 9656 3783

Fax

nicole.kiss@petermac.org

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

No additional documents have been identified.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically