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| ID | Type | Description | Link |
|---|---|---|---|
| 17/049 | Other Grant/Funding Number | Research and Development Endowment Research Grants |
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| Name | Class |
|---|---|
| NHS Grampian | OTHER_GOV |
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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.
In this longitudinal study, the investigators propose to examine the changes in lipid composition and microstructure in breast tumours at baseline and post dietary nitrate intervention through the applications of novel non-invasive magnetic resonance spectroscopy (MRS) methods and diffusion and lipid profiling MR imaging methods in patients. The investigators hypothesise that dietary nitrate disrupts tumour progression in breast cancer.
To assess the effect of dietary nitrate on tumour progression, paired t-tests will be performed on lipid composition measured from tumour between baseline and post intervention. To assess the effect of dietary nitrate on tumour progression, paired t-tests will be performed on lipid composition in the whole breast tissue surrounding tumour between baseline and post intervention. To assess the effect of dietary nitrate on tissue microstructure paired t-tests will be performed on water displacement measured from tumour between baseline and post intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Beetroot | Experimental | 16 patients confirmed with a diagnosis of invasive ductal carcinoma who will undergo wide local excision surgery or mastectomy. All patients in the single arm will undergo a 5 day intervention drinking concentrated beetroot juice and 2 magnetic resonance imaging scan sessions pre and post intervention. MRI scan sessions will be composed of research scans including diffusion and lipid profiling MR imaging methods and MR spectroscopy (MRS) methods. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Beetroot juice | Dietary Supplement | The patient will follow a 5 day dietary nitrate intervention programme, taking 3 doses of 7cl (0.4 g nitrate per dose) concentrated beetroot juice (SPORT shot, James White Drinks, Suffolk, U.K.) a day. |
| Measure | Description | Time Frame |
|---|---|---|
| Baseline: Lipid composition in tumour | Lipid peak volume with units of ratio | Scan one day before intervention (Day 0) |
| Post intervention: Lipid composition in tumour | Lipid peak volume ratio with units of ratio | Scan one day after completion of intervention (Day 6) |
| Baseline: Lipid composition in whole breast tissue surrounding tumour | fat fraction with units of % | Scan one day before intervention (Day 0) |
| Post intervention: Lipid composition in whole breast tissue surrounding tumour | fat fraction with units of % | Scan one day after completion of intervention (Day 6) |
| Baseline: Water displacement in tumour | Water displacement with units of micrometer | Scan one day before intervention (Day 0) |
| Post intervention: Water displacement in tumour | Water displacement with units of micrometer | Scan one day after completion of intervention (Day 6) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vasiliki Mallikourti, MSc | Contact | +44 (0)1224 438351 | r02vm16@abdn.ac.uk | |
| Jiabao He, PhD | Contact | +44 (0)1224 43-7321 | jiabao.he@abdn.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Jiabao He, PhD | University of Aberdeen | Study Chair |
| Vasiliki Mallikourti, MSc | University of Aberdeen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aberdeen Biomedical Imaging Centre | Aberdeen | AB25 2ZD | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24396498 | Background | Graham LJ, Shupe MP, Schneble EJ, Flynt FL, Clemenshaw MN, Kirkpatrick AD, Gallagher C, Nissan A, Henry L, Stojadinovic A, Peoples GE, Shumway NM. Current approaches and challenges in monitoring treatment responses in breast cancer. J Cancer. 2014 Jan 5;5(1):58-68. doi: 10.7150/jca.7047. | |
| 19201649 | Background |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Single Group: trials with a single arm
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Single group with no masking
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| Baker J, Ajani J, Scotte F, Winther D, Martin M, Aapro MS, von Minckwitz G. Docetaxel-related side effects and their management. Eur J Oncol Nurs. 2009 Feb;13(1):49-59. doi: 10.1016/j.ejon.2008.10.003. Epub 2009 Feb 7. |
| 15516961 | Background | Gatenby RA, Gillies RJ. Why do cancers have high aerobic glycolysis? Nat Rev Cancer. 2004 Nov;4(11):891-9. doi: 10.1038/nrc1478. |
| 24791915 | Background | Jones AM. Dietary nitrate supplementation and exercise performance. Sports Med. 2014 May;44 Suppl 1(Suppl 1):S35-45. doi: 10.1007/s40279-014-0149-y. |
| 27600147 | Background | McMahon NF, Leveritt MD, Pavey TG. The Effect of Dietary Nitrate Supplementation on Endurance Exercise Performance in Healthy Adults: A Systematic Review and Meta-Analysis. Sports Med. 2017 Apr;47(4):735-756. doi: 10.1007/s40279-016-0617-7. |
| 25052493 | Background | Bentley R, Gray SR, Schwarzbauer C, Dawson D, Frenneaux M, He J. Dietary nitrate reduces skeletal muscle oxygenation response to physical exercise: a quantitative muscle functional MRI study. Physiol Rep. 2014 Jul 22;2(7):e12089. doi: 10.14814/phy2.12089. Print 2014 Jul 1. |
| D017437 |
| Skin and Connective Tissue Diseases |