ISRCTN14330469Active, not recruitingUnknown
The 6:1 intermittent diet breast cancer prevention programme study
Manchester University NHS Foundation Trust0 sites30 target enrollmentStarted: May 3, 2024Last updated:
Conditions
Trial Snapshot
- Phase
- Unknown
- Status
- Active, not recruiting
- Enrollment
- 30
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- Female
Inclusion Criteria
- •1.Born female and not undergone gender reassignment aged 18-40 years.
- •2.Moderate or high risk of BC (>17% lifetime risk or >10 year risk of BC of >3% at 40)
- •3.BMI > or=20 and < or = 25 Kg/m²
- •4.Able to communicate (written and spoken) in English or other languages
- •5.Able to attend two face to face appointments at MFT at baseline and 4 months
- •6.Not pregnant or planning to become pregnant: Where appropriate potential participants will have a negative urine pregnancy test at screening and agreement to maintain contraception or abstinence for the trial.
Exclusion Criteria
- •1.Previous breast cancer or bilateral preventative mastectomy
- •2.Currently trying to gain weight
- •3.Previously had weight loss surgery or taking weight loss medication
- •4.Have a medical condition that influences diet and weight, for example, diabetes, inflammatory bowel disease or cystic fibrosis.
- •5.Current diagnosis of a psychiatric disorder, for example bipolar psychotic disorder or current self-harm
- •6.Substance abuse or harmful alcohol use as indicated by a score of 16 or above on the Alcohol Use Disorders Identification Test (AUDIT)
- •7.Current or previous diagnosis of an eating disorder
- •8.Participants with severe binge eating assessed by a score of 27 or more on the Binge Eating Scale (BES)
- •9.Participants with severe depression assessed by a score of 15 or more on the Patient Health Questionnaire-9 (PHQ-9) questionnaire
- •10.Participants with severe anxiety assessed by a score of 15 or more on the General Anxiety Disorder (GAD-7) questionnaire.
- •11.Confirmed pregnant via a pregnancy test, planning pregnancy in the next 4 months, or currently breast feeding.
Investigators
Similar Trials
Completed
Not Applicable
Breast Risk Reduction Intermittent Diet Evaluation (BRRIDE) studyMalignant neoplasm of breastCancerBreast cancerISRCTN77916487niversity Hospital of South Manchester (UHSM) NHS Foundation Trust (UK)25
Active, not recruiting
Not Applicable
Preventing Breast cancer through Assumption of Metformin, Diet and Physical Activity - Bremet Dietwomen affected by metabolic syndrome defined by at least three out of five metabolic factors: 1-glucose >110 mg/100 mL 2-triglycerides >150mg/100mL 3-HDL cholesterol <50 mg/100mL 4-waist circumference >88 cm) 5-hypertension SBP>130 mm Hg or DBP >85 mm HMedDRA version: 9.1Level: SOCClassification code 10038604MedDRA version: 9.1Level: SOCClassification code 10029104MedDRA version: 9.1Level: PTClassification code 10007649MedDRA version: 9.1Level: SOCClassification code 10022891EUCTR2008-006527-30-ITISTITUTO NAZIONALE PER LA CURA TUMORI
Completed
Not Applicable
Prevention of breast cancer in high risk women by monitoring microrna expression in nipple aspirate fluid.breast carcinoma100836241000629110006232breast cancerNL-OMON44762niversitair Medisch Centrum Utrecht720
Withdrawn
Not Applicable
A randomised controlled trial of breast cancer patients treated with chemotherapy in a hospital day unit or at home; an analysis of cost and patient reported outcomesCancer - BreastPublic Health - Health service researchBreast cancerACTRN12615000197538A/Prof Suzanne Robinson130
Completed
Not Applicable
Dietary approaches for treatment of the metabolic syndrome in overweight and obese women.Metabolic syndrome in overweight and obese womenDiabetes prevention in overweight and obese womenInsulin resistance in overweight and obese womenDiet and Nutrition - ObesityMetabolic and Endocrine - DiabetesACTRN12610000852055Professor Jim Mann80