Condition category
Nutritional, Metabolic, Endocrine
Date applied
18/08/2008
Date assigned
13/10/2008
Last edited
20/12/2011
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 William Atiomo

ORCID ID

Contact details

D Floor
East Block
School of Human Development
Department of Obstetrics and Gynaecology
University of Nottingham
Queens Medical Centre
Nottingham
NG7 2UH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1

Study information

Scientific title

Acronym

Study hypothesis

To evaluate the feasibility of a definitive trial to test whether in obese anovulatory women with polycystic ovary syndrome (PCOS) a low glycaemic index (GI) diet compared with a 600 kcal deficit hypo-caloric healthy eating approach results in a greater reduction in such risk factors for endometrial cancer as oestrogen levels, insulin resistance, anovulation, obesity, androgens, endometrial thickness, and prevalence of endometrial hyperplasia and pro-oncogenic expression of molecular markers for such endometrial cancer as Pten, p27, Kras and Cyclin D1.

Ethics approval

Derbyshire Research Ethics Committee. Date of approval: 20/06/2006 (ref: 06/Q2401/76)

Study design

Pilot randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Not Specified

Patient information sheet

Condition

Polycystic ovary syndrome

Intervention

1. Baseline clinical interview, assessing menstrual history, current gynaecological, medical and surgical history, past medical, surgical and gynaecological history, family and social history
2. Baseline measurement of body mass index, waist circumference, hip circumference, Ferriman galway score and blood pressure
3. Baseline venepunctures for oestradiol, insulin, glucose, insulin resistance, testosterone, sex hormone binding globulin (SHBG) and luteinising hormone (LH) levels
4. Baseline food diary
5. Baseline pelvic ultrasound scan for endometrial thickness
6. Baseline endometrial biopsy for endometrial hyperplasia and Pten, p27, Kras and Cyclin D1 expression
7. Randomisation to low glycaemic diet or a 600 kcal deficit hypocaloric healthy eating approach
8. Monthly diet classes for the participants, to be taught by a trained dietician for 6 months
9. Monthly assessment of compliance using a food diary
10. Month 6: Repeat assessment of frequency of menstrual cycles, body mass index, waist circumference, insulin, glucose, insulin resistance, testosterone, SHBG, oestradiol, endometrial thickness on pelvic ultrasound, and endometrial biopsy for endometrial hyperplasia and expression of Pten, p27, Kras and Cyclin D1

Women will be flagged at the office of national statistics for the future development of endometrial cancer.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

As this is a pilot study, we do not have a specific biological primary outcome measure. We will however be looking at measures and standard deviations of possible primary outcomes (see below) to inform the definitive trial. The focus of this pilot will be the assessment of the feasibility of the study (eligibility, recruitment, compliance and drop out rate) to help us determine whether an investment in a definitive trial would be value for money.

Possible primary outcomes in the definitive trial include:
1. Change in oestradiol levels, assessed at baseline and Month 6
2. Change in SHBG levels, assessed at baseline and Month 6
3. Change in insulin resistance, assessed at baseline and Month 6
4. Change in expression of Pten, p27, Kras and Cyclin D1 on endometrial biopsy, assessed at baseline and Month 6
5. Prevalence of endometrial hyperplasia on endometrial biopsy at baseline compared with Month 6
6. Proportion of women who have resumed normal menstrual cyclicity by Month 6
7. Reduction in endometrial thickness, assessed at baseline and Month 6
8. Reduction in body mass index by Month 6
9. Change in testosterone levels, assessed at baseline and Month 6
10. In the definitive trial we propose to flag women up at the Office for National Statistics for development of endometrial cancer, however, data collection will be commenced in this pilot study. We do however recognise that even the definitive study may not be powered to detect any significant differences.

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/07/2006

Overall trial end date

30/06/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. An objective diagnosis of polycystic ovary syndrome using the Rotterdam criteria
2. Oligo or amenorrhoea
3. Age above 35
4. Body mass index above 30
5. Patient consent
6. Ability to attend dietary classes at monthly intervals
7. Able to be assessed by pelvic ultrasound imaging and endometrial biopsy

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

40

Participant exclusion criteria

1. Previous or current history of any cancer
2. Inability to attend diet classes at monthly intervals
3. Regular menstrual periods
4. Age below 35
5. Body mass index below 30
6. Unable to be assessed by pelvic ultrasound imaging and endometrial biopsy

Recruitment start date

01/07/2006

Recruitment end date

30/06/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

D Floor
Nottingham
NG7 2UH
United Kingdom

Sponsor information

Organisation

Cancer Research UK (UK)

Sponsor details

Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom
karen.kerr@cancer.org.uk

Sponsor type

Charity

Website

http://www.cancerresearchuk.org

Funders

Funder type

Charity

Funder name

Cancer Research UK (UK) (ref: C20654/A7380)

Alternative name(s)

CRUK

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. 2009 protocol in http://www.ncbi.nlm.nih.gov/pubmed/19477300

Publication citations

  1. Protocol

    Atiomo W, Read A, Golding M, Silcocks P, Razali N, Sarkar S, Hardiman P, Thornton J, Local recruitment experience in a study comparing the effectiveness of a low glycaemic index diet with a low calorie healthy eating approach at achieving weight loss and reducing the risk of endometrial cancer in women with polycystic ovary syndrome (PCOS)., Contemp Clin Trials, 2009, 30, 5, 451-456, doi: 10.1016/j.cct.2009.05.001.

Additional files

Editorial Notes