Malignant Breast Tissue Neoplasm Clinical Trial
— BEETOfficial title:
Is Dietary Nitrate Effective in Reducing Aerobic Glycolysis (AG) in Breast Cancer? - A Longitudinal Study Using Specialist Magnetic Resonance (MR) Methods
Breast cancer is the most prevalent cancer affecting women, with 1 in 8 women in the UK
developing breast cancer in their life time. Chemotherapy drugs, currently used for locally
advanced breast cancers, are associated with side effects while dietary supplements have
complex effects with a relatively small effect size.
Breast tumours have different metabolism compared to healthy tissue, including elevated
lactate production by aerobic glycolysis (AG), an underpinning feature of metabolism in
breast cancer cells. Dietary nitrate, contained in leafy green vegetables and beetroot, has
been shown to improve energy efficiency in exercising skeletal muscle, positioning itself as
a disruptor of AG.
The purpose of this study is to examine if dietary nitrate can disrupt AG and as a result to
halt or even reverse tumour progression and survival. This study will look at scans of breast
tumours using magnetic resonance imaging (MRI). Changes to tumour related biochemical
substances will be measured by advanced magnetic resonance spectroscopy and changes to tissue
structure will be measured by advanced diffusion MRI techniques.
In this study, 16 patients undergoing surgery will be recruited for two MRI scans following a
5 day intervention programme.
| Status | Not yet recruiting |
| Enrollment | 16 |
| Est. completion date | June 30, 2020 |
| Est. primary completion date | April 26, 2020 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Patients with pathologically confirmed invasive ductal carcinoma (Grade 2 or 3) - Undergoing wide local excision surgery or mastectomy Exclusion Criteria: - Started hormone or chemotherapy treatment before recruitment. - Undergoing treatment for concurrent cancer diagnosis. - Taking antibiotics, proton pump or vegetable dietary supplement. |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Aberdeen Biomedical Imaging Centre | Aberdeen |
| Lead Sponsor | Collaborator |
|---|---|
| University of Aberdeen | NHS Grampian |
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Baseline: Lipid composition in tumour | Lipid peak volume with units of ratio | Scan one day before intervention (Day 0) | |
| Primary | Post intervention: Lipid composition in tumour | Lipid peak volume ratio with units of ratio | Scan one day after completion of intervention (Day 6) | |
| Primary | Baseline: Lipid composition in whole breast tissue surrounding tumour | fat fraction with units of % | Scan one day before intervention (Day 0) | |
| Primary | Post intervention: Lipid composition in whole breast tissue surrounding tumour | fat fraction with units of % | Scan one day after completion of intervention (Day 6) | |
| Primary | Baseline: Water displacement in tumour | Water displacement with units of micrometer | Scan one day before intervention (Day 0) | |
| Primary | Post intervention: Water displacement in tumour | Water displacement with units of micrometer | Scan one day after completion of intervention (Day 6) |