None listed
Conditions
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
Interventions
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
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.
Sponsors
The University of Queensland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
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
Outcome results
None listed