Prevention of breast and endometrial cancer using total dietary replacement

Not Applicable

Completed

• Conditions: Cancer prevention; Cancer

• Registration Number: ISRCTN15358157
• Lead Sponsor: Manchester University NHS Foundation Trust

Brief Summary

2022 Protocol article in http://dx.doi.org/10.1136/bmjopen-2021-057161 (added 05/04/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-11
• Study Completion: 2023-04-14
• Last Update Posted: 3 October 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 47

Inclusion Criteria

1. Women aged 30-50 years
2. BMI =30 kg/m2 or =27.5 mg/m2 in Asian and South Asian women
3. Pre-menopausal, with regular menstrual cycles (cycle length 21 to 40 days)
4. Have access to and be able to use a smartphone or tablet running iOS or Android and be able to use the Oviva app OR access and ability to use a telephone
5. Willing to follow the TDR using Optifast® drinks and have previously sampled them
6. Agree to maintain non-hormonal contraception (barrier or abstinence) until both sets of biopsies are complete and must have a negative urine pregnancy test at screening.
7. Women with Type 2 Diabetes Mellitus on diet +/- Metformin control can be included.
8. Must be able to read, understand and communicate in English

Exclusion Criteria

1. Prior history of breast or endometrial cancer or preinvasive breast disease (Ductal Carcinoma in situ (DCiS), Lobular Carcinoma in situ (LCiS), Atypical Ductal Hyperplasia (ADH), Atypical Lobular Hyperplasia (ALH))
2. Any hormonal contraceptive (including progestin releasing IUCD, such as Mirena®) in the 12 weeks prior to study entry
3. Preventative Tamoxifen therapy within the last 6 months
4. Prior anti-progestin therapy (e.g. Ulipristal Acetate) within the last 6 months
5. Carrier of the BRCA 1 or 2 gene
6. Confirmed pregnant via a pregnancy test at screening, planning pregnancy in the next 12 months, or currently breast feeding
7. Taking prohibited medications (see Appendix 1) including warfarin or novel anticoagulants (NOAC), low molecular weight heparin (LMWH) or equivalent anti-coagulants, anti-psychotic medication, anti-diabetic medication other than Metformin
8. Currently on treatment with Orlistat or other pharmacological treatments for weight loss
9. Chronic use of steroids (more than 20mg daily of prednisolone or its equivalent)
10. Previously had bariatric surgery for weight loss including gastric bypass and sleeve gastrectomy
11. Hypersensitivity to any of the ingredients of Optifast® e.g. lactose intolerance
12. Allergies to the ingredients of Optifast® e.g. fish, milk, soy
13. Substance abuse or harmful alcohol use as indicated by a score of 16 or above on the Alcohol Use Disorders Identification Test (AUDIT)
14. Diagnosed with an eating disorder, or patients with severe binge eating assessed by a score of 27 or more on the Binge Eating Scale (BES)
15. Severe depression assessed by a score of 15 or more on the Patient Health Questionnaire-9 (PHQ-9) questionnaire.
16. Severe anxiety assessed by a score of 15 or more on the General Anxiety Disorder (GAD-7) questionnaire.
17. Psychiatric or physical comorbidity or scheduled for major surgery, which in the opinion of the treating medical physician, or the Chief Investigator (CI), would compromise their safety or adherence to the study
18. Lack capacity or are unable to read or understand written or verbal instructions in English

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Epithelial cell proliferation (Ki67) in the breast and endometrium at baseline and 12 +/- 4 weeks measured using biopsy