None listed
Conditions
Brief summary
The aim of this study is to explore physiological and psychosocial differences between women classified as overweight/obese with premenopausal breast cancer, and postmenopausal breast cancer, and compare their response to a partial meal replacement dietary intervention. Who is it for? You may be eligible to participate in this study if you are: • A female who was premenopausal at the time of being diagnosed with breast cancer, and has finished primary treatment (surgery, chemotherapy and radiation); or • A female who was postmenopausal at the time of being diagnosed with breast cancer, and has finished primary treatment (surgery, chemotherapy and radiation). Study details All participants in this study will undergo a dietary intervention. This will consist of a partial meal replacement diet in conjunction with face-to-face sessions, telephone calls and a meal replacement booklet to support women to lose weight and increase exercise. All women will receive a 12-week dietary program with regular sessions with an Accredited Practising Dietitian. Participants will be prescribed meal replacement products (KickStart soups and shakes) to replace two meals per day for a period of 11 weeks followed by 1-2 shakes per day for the remaining week (based on the individual’s requirements and preferences). On the partial meal replacement diet, participants will be advised to eat a main meal (lunch or dinner) consisting of 2 cups of non-starchy vegetables, lean protein (serving based on protein requirements of 1-1.2g/kg body weight) and 1 teaspoon of olive oil. Data will be collected at baseline and 12 weeks (end-of-intervention). All participants will be undergo assessments at enrolment, 6 weeks and 12 weeks (end-of-intervention) in order to evaluate any changes in body mass, body composition, dietary intake, physical activity, quality of life and psychological well-being. It is hoped that this study will enable us to determine whether a larger trial would be feasible.
Interventions
All participants will receive a 12-week dietary program with regular individual sessions with an Accredited Practising Dietitian (APD). Women will have an initial face-to-face session with an APD, and 3-7 telephone contacts over the 12 weeks.
Participants will be prescribed meal replacement products (KickStart soups and shakes) to replace two meals per day for a period of 12 weeks. Participants will be supplied with 2 meal replacement products (885kJ per meal replacement product) per day fo
All participants will receive a 12-week dietary program with regular individual sessions with an Accredited Practising Dietitian (APD). Women will have an initial face-to-face session with an APD, and 3-7 telephone contacts over the 12 weeks. Participants will be prescribed meal replacement products (KickStart soups and shakes) to replace two meals per day for a period of 12 weeks. Participants will be supplied with 2 meal replacement products (885kJ per meal replacement product) per day for 11 weeks followed by 1-2 shakes per day for the remaining week (based on the individual’s requirements and preferences) at no cost to the participant. On the partial meal replacement diet, participants will be advised to eat a main meal (lunch or dinner) consisting of 2 cups of non-starchy vegetables, lean protein (serving based on protein requirements) and 1 teaspoon of olive oil. Participant’s protein requirements will be calculated, based on 1-1.2g/kg of actual body weight to minimise loss of fat free mass. During the course of the meal replacement diet, participants are advised to consume 2 litres of water per day. Participants will also receive a detailed booklet designed specifically for the study, with information about non-starchy vegetables approved on the diet, additions to the meal replacement products to vary the flavour and recipe ideas for the food based meal. The booklet also includes tips for managing side effects (such as constipation) and addresses frequently asked questions. During the final intervention contact in the 12 week intervention, participants will be prescribed a recommended kilojoule intake based on age and baseline weight to maintain weigh loss. The APD will provide individualised advice including improving portion control and eating regular meals along with kilojoule counting to achieve maintenance of weight loss. In addition, all participants will be encouraged to aim for a diet high in vegetables (5 serves per day), fruits (2 serves per day), whole grains, fibre (greater than or equal to 25g per day) and low in saturated fat, consistent with guidelines for breast cancer survivorship, weight management and the Australian dietary guidelines for the general population.
Sponsors
The University of Queensland
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Women with premenopausal breast cancer - Diagnosed with invasive breast cancer (stage I-IIIc) - Oestrogen receptor positive disease (ER+) - Premenopausal at diagnosis - BMI greater than or equal to 27kg/m2 - Finished primary treatment (i.e. surgery, chemotherapy and/or radiotherapy) - Received chemotherapy treatment for breast cancer Women with postmenopausal breast cancer • Diagnosed with invasive breast cancer (stage I-IIIc) • Oestrogen receptor positive disease (ER+) • Postmenopausal at diagnosis • BMI greater than or equal to 27kg/m2 • Finished primary treatment (i.e. surgery, chemotherapy and/or radiotherapy) • Aged between 58-63 years at diagnosis (under 65 years at study enrolment) • Received chemotherapy treatment for breast cancer
Exclusion criteria
Women with premenopausal breast cancer - Ductal carcinoma in situ (DCIS; stage 0), distant metastases (stage IV) or triple negative breast cancer (TNBC) - Diagnosed more than two years ago - Currently pregnant or plan to conceive during the study period - Contraindication to participating in an unsupervised program - active heart disease, impaired mobility, Insulin dependent diabetes, low liver/kidney function (from blood test) - Currently taking or planning to start taking weight loss medications - Insufficient English to complete assessments and participate in the intervention - Unable to travel to Brisbane to complete study assessments - Reporting depression/anxiety as a current significant problem that would interfere with study participation. - Allergy or intolerance to soy, dairy or lactose Women with postmenopausal breast cancer • Ductal carcinoma in situ (DCIS; stage 0), distant metastases (stage IV) or triple negative breast cancer (TNBC) • Diagnosed more than two years ago • Currently pregnant or plan to conceive during the study period • Contraindication to participating in an unsupervised program - active heart disease, impaired mobility, Insulin dependent diabetes, low liver/kidney function (from blood test) • Currently taking or planning to start taking weight loss medications • Insufficient English to complete assessments and participate in the intervention • Unable to travel to Brisbane to complete study assessments • Reporting depression/anxiety as a current significant problem that would interfere with study participation. • Allergy or intolerance to soy, dairy or lactose
Outcome results
None listed