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Clinical Trials/ISRCTN11023622
ISRCTN11023622
Completed
Not Applicable

A pilot study to determine the effect of dietary intervention on novel biomarkers of breast cancer risk

Record Provided by the NHSTCT Register - 2007 Update - Department of Health0 sites30 target enrollmentSeptember 28, 2007
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Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Enrollment
30
Status
Completed
Last Updated
8 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 28, 2007
End Date
TBD
Last Updated
8 years ago
Study Type
Interventional
Sex
Female

Investigators

Sponsor
Record Provided by the NHSTCT Register - 2007 Update - Department of Health

Eligibility Criteria

Inclusion Criteria

  • •Pre\-menopausal women (age 35\-50\) at moderate to high risk of developing breast cancer. Study participants will be recruited from the breast clinic at NNUH and will be eligible for recruitment onto the study if they have one or more of the medium or high risk family histories as defined by the NICE guidelines (May 2004\).

Exclusion Criteria

  • •Added 15/05/2008:
  • •1\. Current or previous diagnosis of breast cancer as defined by invasive ductal carcinoma or invasive lobular carcinoma
  • •2\. Current or previous diagnosis of cancer or metastases at any site other than breast
  • •3\. Diagnosis of hypertension requiring active treatment or diabetes
  • •4\. Coronary heart disease
  • •5\. Gastrointestinal disease (or other systemic disease requiring active treatment)
  • •6\. Regularly taking any prescribed medication that may affect the study data
  • •7\. Currently taking oral contraceptives or fitted with a hormone releasing device or coil
  • •8\. Pregnant or lactating in the previous 12 months or regularly using antacids or laxatives (at least once a week).
  • •9\. Routinely taking soy or selenium supplements in the previous 12 months or regularly taking any other dietary or herbal supplements and unwilling to discontinue their use for the duration of the study

Outcomes

Primary Outcomes

Not specified

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