Breast cancer Cancer Malignant neoplasm of breast
Conditions
Interventions
Group 1: Diet and exercise. This group have an individual session with the trial dietitian and are asked to follow our 5:2 calorie restricted diet tailored to their needs and preferences. This group w
Sponsors
Manchester University NHS Foundation Trust
Eligibility
Sex/Gender
Female
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: As of 17/05/2016: 1.Women with histologically confirmed breast cancer 2. Patients with ABC, i.e. locally advanced disease that is not amenable to curative surgical resection or with metastatic disease 3. HER2 positive or negative 4. ER and/or PR positive or negative 5. If ER positive there is no restriction on the number of lines of previous endocrine therapy for ABC 6. Performance status 0 or 1 7. Predicted life expectancy = 3 months 8. BMI =24 kg/m2 9. Expressing a wish to lose weight 10. Not already entered or planned to enter a trial of an investigational medicinal product (IMP) for this line of therapy 11. Age >18 (can be pre or post menopausal) 12. Measurable or non-measurable disease by RECIST v1.1 13. Patients with brain or leptomeningeal metastases are eligible as long as all sites have been treated with radiotherapy (+/- surgery) with evidence of disease control at least 8 weeks after the last dose 14. Women in whom further endocrine therapy is planned after chemotherapy are eligible. The treating clinician must state what endocrine therapy is planned before chemotherapy is initiated 15. Women with thyroid dysfunction are eligible provided they are euthyroid and on a stable dose of thyroxine for the last 6 months Previous: 1. Women with histologically confirmed breast cancer 2. Patients with advanced breast cancer (ABC) i.e. locally advanced disease that is not amenable to curative surgical resection or with metastatic disease 3. Her2 negative by IHC defined as 0/1+ or 2+ with FISH/DDISH/CISH ratio 25 kg / m 2 and body fat >30% (determined from impedence/ or CT scan) or waist circumference > 80cm 10. Expressing a wish to lose weight 11. Not already entered or planned to enter a trial of an investigational medicinal product (IMP) for this line of therapy 12. Age >18 (can be pre or post menopausal) 13. Measurable or nonmeasurable disease by RECIST v1.1 14. Patients with brain or leptomeningeal metastases are eligible as long as all sites have been treated with radiotherapy (+/surgery) with evidence of disease control at least 8 weeks after the last dose 15. Women in whom further endocrine therapy is planned after chemotherapy are eligible. The treating clinician must state what endocrine therapy is planned before chemotherapy is initiated. 16. Women with thyroid dysfunction are eligible pro
Exclusion criteria
Exclusion criteria: As of 17/05/2016: 1. Physical or psychiatric conditions which may reduce compliance to and the safety of diet or resistance exercise, e.g. 1.1. Serious digestive and/or absorptive problems, including active inflammatory bowel disease. 1.2. Psychiatric disorders or conditions, e.g. history of eating disorders, untreated major depression, psychosis, substance abuse, severe personality disorder. 1.3. Bone metastases at risk of pathological fracture or that would limit resistance exercise through pain in all three areas of the body that are covered by the resistance exercises (upper limbs, trunk and lower limbs). Metastases may be ok if other areas of the body can safely be exercised. 2. Medications affecting adiposity or muscle mass and function and energy intake e.g. continuous daily steroids for longer than 4 weeks (short term steroids with chemotherapy are acceptable) 3. Diabetics on insulin or sulphonylureas (glibenclamide, gliclazide, glimepiride, glipizide, tolbutamide) as they could experience hypoglycaemia on restricted days of the intermittent diet (diabetics treated with diet alone or with any other medication including metformin are eligible) 4. Greater than Day 15 of this course of chemotherapy. 5. Visceral metastases that, in the opinion of the treating clinician, would result in death within 3 months if no response was achieved with this line of chemotherapy 6. Symptomatic or uncontrolled brain or leptomeningeal metastases Previous: 1. Physical or psychiatric conditions which may reduce compliance to and the safety of diet or resistance exercise eg. serious digestive and/or absorptive problems, including active inflammatory bowel disease. 2. Psychiatric disorders or conditions, e.g. history of eating disorders, untreated major depression, psychosis, substance abuse, severe personality disorder. 3. Bone metastases at risk of pathological fracture or that would limit resistance exercise through pain. 4. Medications affecting adiposity or muscle mass and function and energy intake e.g. continuous daily steroids for longer than 4 weeks (short term steroids with chemotherapy are acceptable) 5. Diabetics on insulin or sulphonylureas (glibenclamide, gliclazide, glimepiride, glipizide, tolbutamide) as they could experience hypoglycaemia on restricted days of the intermittent diet (diabetics treated with diet alone or with any other medication including metformin are eligible) 6. Already commenced this course of first or second line chemotherapy 7. Visceral metastases that, in the opinion of the treating clinician, would result in death within 3 months if no response were achieved with this line of chemotherapy 8. Patients relapsing within 12 months of adjuvant/neoadjuvant chemotherapy 9. Symptomatic or uncontrolled brain or Leptomeningeal metastases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to Treatment Failure (TTF) i.e. the time from randomisation to disease progression, death | — |
Countries
England, United Kingdom
Outcome results
None listed