NCT03944226

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 7, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 9, 2019

Completed
4 days until next milestone

Study Start

First participant enrolled

May 13, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 26, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

May 14, 2019

Status Verified

May 1, 2019

Enrollment Period

12 months

First QC Date

May 7, 2019

Last Update Submit

May 13, 2019

Conditions

Malignant Breast Tissue Neoplasm

Keywords

Beetroot juiceMagnetic Resonance ImagingBreast cancer

Outcome Measures

Primary Outcomes (6)

  • 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)

Study Arms (1)

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.

Dietary Supplement: Beetroot juice

Interventions

Beetroot juiceDIETARY_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.

Beetroot

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with pathologically confirmed invasive ductal carcinoma (Grade 2 or 3)
  • Undergoing wide local excision surgery or mastectomy

You may not qualify if:

  • Started hormone or chemotherapy treatment before recruitment.
  • Undergoing treatment for concurrent cancer diagnosis.
  • Taking antibiotics, proton pump or vegetable dietary supplement.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aberdeen Biomedical Imaging Centre

Aberdeen, AB25 2ZD, United Kingdom

Location

Related Publications (6)

  • 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.

    PMID: 24396498BACKGROUND

  • 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.

    PMID: 19201649BACKGROUND

  • Gatenby RA, Gillies RJ. Why do cancers have high aerobic glycolysis? Nat Rev Cancer. 2004 Nov;4(11):891-9. doi: 10.1038/nrc1478.

    PMID: 15516961BACKGROUND

  • 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.

    PMID: 24791915BACKGROUND

  • 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.

    PMID: 27600147BACKGROUND

  • 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.

    PMID: 25052493BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Jiabao He, PhD

    University of Aberdeen

    STUDY CHAIR

  • Vasiliki Mallikourti, MSc

    University of Aberdeen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Vasiliki Mallikourti, MSc

CONTACT

+44 (0)1224 438351r02vm16@abdn.ac.uk

Jiabao He, PhD

CONTACT

+44 (0)1224 43-7321jiabao.he@abdn.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Single group with no masking
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: Single Group: trials with a single arm
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2019

First Posted

May 9, 2019

Study Start

May 13, 2019

Primary Completion

April 26, 2020

Study Completion

June 30, 2020

Last Updated

May 14, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)