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Is Dietary Nitrate Effective in Reducing Aerobic Glycolysis in Breast Cancer? (BEET)

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ClinicalTrials.gov Identifier: NCT03944226
Recruitment Status : Not yet recruiting
First Posted : May 9, 2019
Last Update Posted : May 14, 2019
Sponsor:
Collaborator:
NHS Grampian
Information provided by (Responsible Party):
University of Aberdeen

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Malignant Breast Tissue Neoplasm Dietary Supplement: Beetroot juice Not Applicable

Detailed Description:

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.

  1. Is there a significant difference in lipid composition in the tumour measured by MRS between baseline and post dietary nitrate intervention?
  2. Is there a significant difference in lipid composition in the whole breast tissue surrounding tumour measured by MRI between baseline and post dietary nitrate intervention?
  3. Is there a significant difference in tissue microstructure measured by MRI between baseline and post dietary nitrate intervention in the breast tissue?

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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single Group: trials with a single arm
Masking: None (Open Label)
Masking Description: Single group with no masking
Primary Purpose: Basic Science
Official Title: Is Dietary Nitrate Effective in Reducing Aerobic Glycolysis (AG) in Breast Cancer? - A Longitudinal Study Using Specialist Magnetic Resonance (MR) Methods
Estimated Study Start Date : May 13, 2019
Estimated Primary Completion Date : April 26, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Beetroot
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.
Dietary Supplement: Beetroot juice
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.




Primary Outcome Measures :
  1. Baseline: Lipid composition in tumour [ Time Frame: Scan one day before intervention (Day 0) ]
    Lipid peak volume with units of ratio

  2. Post intervention: Lipid composition in tumour [ Time Frame: Scan one day after completion of intervention (Day 6) ]
    Lipid peak volume ratio with units of ratio

  3. Baseline: Lipid composition in whole breast tissue surrounding tumour [ Time Frame: Scan one day before intervention (Day 0) ]
    fat fraction with units of %

  4. Post intervention: Lipid composition in whole breast tissue surrounding tumour [ Time Frame: Scan one day after completion of intervention (Day 6) ]
    fat fraction with units of %

  5. Baseline: Water displacement in tumour [ Time Frame: Scan one day before intervention (Day 0) ]
    Water displacement with units of micrometer

  6. Post intervention: Water displacement in tumour [ Time Frame: Scan one day after completion of intervention (Day 6) ]
    Water displacement with units of micrometer



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03944226


Contacts
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Contact: Vasiliki Mallikourti, MSc +44 (0)1224 438351 r02vm16@abdn.ac.uk
Contact: Jiabao He, PhD +44 (0)1224 43-7321 jiabao.he@abdn.ac.uk

Locations
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United Kingdom
Aberdeen Biomedical Imaging Centre
Aberdeen, United Kingdom, AB25 2ZD
Contact: Vasiliki Mallikourti, MSc    +44 (0)1224 438351    r02vm16@abdn.ac.uk   
Principal Investigator: Vasiliki Mallikourti, MSc         
Sponsors and Collaborators
University of Aberdeen
NHS Grampian
Investigators
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Study Chair: Jiabao He, PhD University of Aberdeen
Principal Investigator: Vasiliki Mallikourti, MSc University of Aberdeen
Publications:
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Responsible Party: University of Aberdeen
ClinicalTrials.gov Identifier: NCT03944226    
Other Study ID Numbers: 2-114-18
17/049 ( Other Grant/Funding Number: Research and Development Endowment Research Grants )
First Posted: May 9, 2019    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Aberdeen:
Beetroot juice
Magnetic Resonance Imaging
Breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases