Condition category
Cancer
Date applied
30/01/2004
Date assigned
30/01/2004
Last edited
02/10/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Sheila A. Bingham

ORCID ID

Contact details

MRC Dunn Human Nutrition Unit
Cambridge
CB2 2XY
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

To determine the effects of taking a red clover-derived isoflavone supplement daily for one year on mammographic breast density. Effects on oestradiol, follicle-stimulating hormone (FSH), luteinising hormone (LH), lymphocyte tyrosine kinase activity and menopausal symptoms were also assessed.

Ethics approval

All study procedures were approved by the Dunn Human Nutrition Unit Ethics Committee, and the Cambridge Local Research Ethics Committee.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Breast cancer

Intervention

Red clover-derived isoflavone tablet (26 mg biochanin A, 16 mg formononetin, 1 mg genistein and 0.5 mg daidzein) or placebo.

Intervention type

Supplement

Phase

Not Specified

Drug names

Red clover-derived isoflavone supplement

Primary outcome measures

Change in:
1. Mammographic breast density
2. Serum oestradiol, FSH and LH
3. Menopausal symptoms
4. Lymphocyte tyrosine kinase activity

Measured from baseline to 12 months.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/05/1997

Overall trial end date

31/12/1999

Reason abandoned

Eligibility

Participant inclusion criteria

1. Women aged 49 - 65 years
2. Wolfe's P2 or DY (dense parenchyma) mammographic breast patterns

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

205

Participant exclusion criteria

Not provided at time of registration.

Recruitment start date

01/05/1997

Recruitment end date

31/12/1999

Locations

Countries of recruitment

United Kingdom

Trial participating centre

MRC Dunn Human Nutrition Unit
Cambridge
CB2 2XY
United Kingdom

Sponsor information

Organisation

Medical Research Council (UK)

Sponsor details

20 Park Crescent
London
W1B 1AL
United Kingdom

Sponsor type

Research council

Website

Funders

Funder type

Industry

Funder name

Novogen Ltd (Australia)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Medical Research Council (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15084240

Publication citations

  1. Results

    Atkinson C, Warren RM, Sala E, Dowsett M, Dunning AM, Healey CS, Runswick S, Day NE, Bingham SA, Red-clover-derived isoflavones and mammographic breast density: a double-blind, randomized, placebo-controlled trial [ISRCTN42940165]., Breast Cancer Res., 2004, 6, 3, R170-9, doi: 10.1186/bcr773.

Additional files

Editorial Notes