Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610001005044
Ethics application status
Approved
Date submitted
8/09/2010
Date registered
18/11/2010
Date last updated
14/01/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
The Muscle Mass, Omega-3, Diet, Exercise & Lifestyle (MODEL) Study: a nutrition program for women after breast cancer treatment
Scientific title
In breast cancer survivors, which of three nutrition interventions (Omega-3 capsules versus nutrition and exercise education versus a combination of both) is more effective in improving lean body mass, inflammation and quality of life
Secondary ID [1] 252658 0
Does not have Secondary ID
Universal Trial Number (UTN)
U1111-1116-8520
Trial acronym
The MODEL Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer Survivors 258153 0
Condition category
Condition code
Cancer 258331 258331 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Both the omega-3 fatty acid doses and the CBT will begin on Day 1 of the treatment phase. Baseline assessments will have occurred 1 week prior to the start of the treatment phase.
Group 2: 3g/day of Omega-3 fatty acids
Group 3: 12 week Cognitive Behavioural Therapy (CBT) Healthy eating and exercise education, 3g/day of Omega-3 fatty acids
Omega-3 fatty acid intervention includes a dose of 5 oral capsules daily. The dose will contain a total of 1.75g of eicosapentanoic acid (EPA) and 1.25g of docosahexanoic acid (DHA). The placebo dose will be 5 oral capsules that contain vegetable oil. Doses will continue daily for 6 months.
The CBT healthy eating and exercise intervention will consist of weekly sessions (duration: 1-1:15hrs/session) for 6 weeks, with fortnightly sessions for the 2nd 6 weeks. I.e. 9 sessions in total. Sessions will be delivered face-to-face by an accredited dietitian and exercise physiologist. General topics will cover healthy eating, goal setting, exercise and fitness. Each session will also include a group fitness that comprises 30 minutes of the session. The type of exercise will be a low intensity warm up and then resistance training using elastic resistance bands. Stretching will occur each session. Time is also taken to educate participants to progress their exercise program at home. Exercises at home may include walking, cycling, running, swimming or other modalities depending on each participants preference.
Intervention code [1] 257170 0
Lifestyle
Intervention code [2] 257171 0
Behaviour
Intervention code [3] 257172 0
Treatment: Other
Comparator / control treatment
Group 1: 12 week Cognitive Behavioural Therapy (CBT) Healthy eating and exercise education program, plus a 5 oral capsule dose of placebo oil (made of vegetable oil that contains minimal omega-3 fatty acids).
Control group
Placebo

Outcomes
Primary outcome [1] 259185 0
Changes in body composition- lean body mass and fat mass. Body composition will be measured primarily by air displacement plethysmography (ADP), the specific brand of the equipment is called the, BodPod. Additional measures will be a waist and hip circumference via tape measure, and bio-electrical impedance to determine lymphoedema status. Trained Dietitians will take all measurements.
Timepoint [1] 259185 0
Baseline, 12 weeks and 26 weeks
Secondary outcome [1] 265539 0
High sensitivity - C- reactive protein. Plasma assay of blood sample from each participant
Timepoint [1] 265539 0
Baseline, 12 weeks, 26 weeks
Secondary outcome [2] 265540 0
Quality of Life - Functional Assessment of Cancer Therapy - Breast plus 4 items for lymphoedema. (FACT-B+4)
Timepoint [2] 265540 0
Baseline, 12 weeks, 26 weeks

Eligibility
Key inclusion criteria
Breast cancer survivor. I.e. successfully completed surgery, radiotherapy and/or chemotherapy with no sign of existing disease.
Treatment was completed less than 12 months ago
Body Mass Index (BMI) of 20-35kg/m2
No pre-exisiting cardiovascular disease or diabetes
Minimum age
18 Years
Maximum age
80 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Metastatic disease.
BMI <20 or >35kg/m2
History of cardiovascular disease or diabetes
Physical limitation preventing light to moderate exercise
Mental illness or other inhibiting mental condition
Pregnancy
At discretion of medical oncologist

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Partially blinded - those in Group 2 (omega-3 alone), both assessors and participants will know of the treatment.
Double blinded - those in Group 3 (CBT education+placebo) & Group 1 (CBT education+omega-3), both participants and assessors will not know if they have the active treatment (omega-3) or the placebo (vegetable oil)
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/01/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
135
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 3217 0
4000

Funding & Sponsors
Funding source category [1] 257620 0
Charities/Societies/Foundations
Name [1] 257620 0
The Wesley Research Institute
Country [1] 257620 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
Level 5 Human Movement Studies Building
The University of Queensland
St Lucia
4067
Country
Australia
Secondary sponsor category [1] 256841 0
Charities/Societies/Foundations
Name [1] 256841 0
The Wesley Research Institute
Address [1] 256841 0
Level 8
The Wesley Hospital
451 Coronation Drv
Auchenflower
QLD
4066
Country [1] 256841 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260057 0
The Wesley Research Institute Human Research Ethics Committee
Ethics committee address [1] 260057 0
Level 8
East Wing
The Wesley Hospital
451 Coronation Drv
Auchenflower
4066
QLD
Ethics committee country [1] 260057 0
Australia
Date submitted for ethics approval [1] 260057 0
14/09/2010
Approval date [1] 260057 0
27/10/2010
Ethics approval number [1] 260057 0
1034

Summary
Brief summary
This is a nutrition program for women after breast cancer treatment, called The Muscle Mass, Omega-3, Diet, Exercise and Lifestyle (MODEL) Study. Who is it for? You can join this study if you are a woman who is a breast cancer survivor. In other words, you have successfully completed surgery, radiotherapy and/or chemotherapy with no sign of existing disease, and treatment was completed less than 12 months ago. You must be aged from 18 to 80 years. Trial details Participants will be randomly allocated to one of three groups. One group will take a nutritional supplement of 3g/day of Omega-3 fatty acids for 6 months. A second group will take Omega-3 in conjunction with 12 weeks of Cognitive Behavioural Therapy (CBT) healthy eating and exercise education. The third group will undergo the CBT program and take placebo capsules. Participants will be monitored at the start of the program and at 12 and 26 weeks. The study aims to measure any changes in lean body mass, changes in inflammation and changes in quality of life
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31622 0
Address 31622 0
Country 31622 0
Phone 31622 0
Fax 31622 0
Email 31622 0
Contact person for public queries
Name 14869 0
Cameron McDonald
Address 14869 0
Level 5 Human Movement Studies Building
University of QLD
St Lucia
4067
Country 14869 0
Australia
Phone 14869 0
+61411380566
Fax 14869 0
+61733112385
Email 14869 0
[email protected]
Contact person for scientific queries
Name 5797 0
Cameron McDonald
Address 5797 0
Level 5 Human Movement Studies Building
University of QLD
St Lucia
4067
Country 5797 0
Australia
Phone 5797 0
+61411380566
Fax 5797 0
+61733112385
Email 5797 0
[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
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Documents added automatically
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