None listed
Conditions
Brief summary
Tamoxifen and the aromatase inhibitors letrazole, anastrozole and exemestane are commonly prescribed following surgery with the intent of reducing the likelihood that the breast cancer returns in the future. They work by blocking the effects of oestrogen & progesterone, hormones found naturally in the body, including in the brain. Some side effects from taking these drugs are poor memory, difficulties with concentration and memory, hot flushes, sweating & tiredness. Some researchers think that these memory and concentration problems are due to low oestrogen levels in the brain. Research shows that magnesium (Mg) levels in the body are controlled by oestrogen. We would like to find out if poor memory & concentration in this group of women, may be caused by low Mg caused by low oestrogen. Mg is a mineral and is important for many functions in the body. We tend to get the Mg we need from our food. If our levels of Mg are low however, we can take it as a supplement. Some studies of people taking Mg supplement have shown an improvement in their memory and concentration. Hot flushes & tiredness in menopausal women have also been shown to reduce in some studies. We want to look at the effect of Mg on improving memory and concentration in women on endocrine therapy for the treatment of breast cancer. This study is a pilot study, to see if a larger one will work. We will look at the results of concentration and memory tests in women who have taken Mg and those who have taken a placebo. The participant, or the Dr, will not know if they are taking the Mg or placebo. The results will give us a useful indication about whether supplementing the diet with Mg can help reduce some of the memory and concentration problems that women on endocrine therapy experience. We will also see if Mg helps with hot flushes and fatigue. We are looking to enrol 50 women for this pilot study in NZ.
Interventions
400mg elemental magnesium or matched placebo capsule taken daily for three months.
Adherence determined by capsule count when bottle returned.
Sponsors
University of Auckland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Women 18 years or older with early breast cancer on adjuvant endocrine therapy for at least 6 months. 2. Receiving either tamoxifen or an aromatase inhibitor. 3. Able to provide written informed consent in English (NB: The NIH Toolbox is only available in English).
Exclusion criteria
1. Evidence of metastatic disease 2.ECOG>1 3.Abnormal renal function defined as a serum creatinine of >1.5 x upper limit of normal. 4.Abnormal hepatic function defined as a bilirubin of >1.5 x the upper limit of normal, except in Gilbert’s Syndrome, or ALT or ALP >2.5 x the upper limit of normal. 5.Inadequate haematological function defined as haemoglobin < 100g/L or neutrophil count < 1.5 x E+9/L or platelet count < 120 x E+9/L 6.Inflammatory bowel disease or other bowel disorder that causes ongoing diarrhoea. 7.Any known cause of hypomagnesaemia, including: current treatment with loop diuretics, e.g. frusemide or thiazide; cyclosporine; amphotericin B; pentamidine; aminoglycosides; EGFR antagonists, e.g. cetuximab; past treatment with cisplatin; hypercalcaemia; uncontrolled diabetes; excess alcohol consumption; known familial magnesium wasting syndrome. 8.A major psychiatric disorder and/or heavy alcohol, or illicit drug consumption, a history of traumatic brain injury or any condition unrelated to breast cancer treatment known to affect cognitive function. 9.Receiving antidepressants, sedatives such as some antihistamines or gabapentin. 10.Women who have been taking magnesium supplement within the last one month.
Outcome results
None listed