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
Funders
Funder type
Charity
Funder name
Cancer Research UK (UK) (ref: C20654/A7380)
Alternative name(s)
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
-
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.