Time-restricted eating for menopausal women and those on hormone therapy for breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Participants are women aged 40–65 with BMI 25–40 kg/m2 who are either in physiological menopause or experiencing menopause-related symptoms while taking aromatase inhibitors for hormone-sensitive non-metastatic breast cancer. After a run-in period to confirm baseline eating patterns, participants are randomized to a 12-week 16-hour daily fast/8-hour eating window or to continue their usual eating pattern, with total participation lasting 14 weeks and an optional 12-month follow-up. The intervention uses smartphone food photos and monitoring to support adherence and outcome measurement. Primary outcomes focus on weight and menopause-related symptoms, with safety and feasibility also tracked.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Women with confirmed physiological menopause without current anti-cancer treatment (group A), or women with menopausal symptoms in the context of aromatase inhibitors used as adjuvant therapy for hormone-sensitive non-metastatic breast cancers regardless of physiological menopause before the cancer diagnosis (group B)
* Age 40-65 years
* Body mass index 25-40 kg/m2
* Stable weight (± 2 kg) over the previous month
* Eating window ≥ 12 hours (self-reported and measured during the run-in phase)
* Able to give informed consent and follow the study procedures for the entire duration
* Confident use of a smartphone and able to take regular pictures of food/drinks

Exclusion Criteria:

* On a hypocaloric restrictive diet, intermittent fasting or in a weight management program over the previous month
* Previous bariatric surgery or planned during the study
* Active eating disorder(s) or major mental illness at inclusion
* Psychoactive treatment with recent or planned changes of drug compound or dosage
* Treatments affecting body weight (e.g. glucocorticoids, GLP-1 receptor analogues)
* Diabetes with hypoglycemic drug(s) will be excluded, however those with prediabetes (as defined by the American Diabetes Association) or diabetes with no risk of hypoglycemia (i.e. treated with non-hypoglycemic drugs or without medication) will be included
* Active metabolic bone diseases (e.g. Paget disease, osteomalacia), however women with osteoporosis will be included
* Shift work comprising night shifts (working between 11pm and 6am) over the previous 2 weeks or planned during the study
* Travel/trip to a different time zone (≥ 2-hour time difference) over the previous 2 weeks or planned during the study
* Enrolled in another interventional clinical trial (medication, surgery, medical device) over the previous 2 weeks or planned during the study

Where it's running

• Geneva University Hospitals
  Geneva, Canton of Geneva, Switzerland Recruiting

Study contacts

• Study coordinator: Tinh-Hai Collet, MD
• Email: tinh-hai.collet@hug.ch
• Phone: +41-22-372 91 92

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.