Effect of a Brassicaceae-Enriched Diet on Menopausal Symptoms in Women With Breast Cancer Receiving Antiestrogen Therapy

This study aims to evaluate whether increasing the intake of Brassicaceae vegetables may help reduce menopausal symptoms in women with hormone-sensitive breast cancer who are receiving adjuvant antiestrogen therapy. Participants are randomly assigned to one of two groups. Women in the intervention group receive nutritional advice to include at least five servings per week of Brassicaceae vegetables, such as broccoli, cabbage, cauliflower, Brussels sprouts, radishes, mustard, or other vegetables from this family, in their usual diet. Women in the control group receive a standard nutritional assessment without specific advice to increase Brassicaceae intake. Clinical and nutritional assessments are performed at the beginning of the study and after 3 and 6 months. The main purpose is to compare vasomotor menopausal symptoms, particularly hot flashes and night sweats, between the two groups. The study also evaluates other menopausal symptoms, body measurements, blood pressure, and selected blood markers. After the 6-month assessment, participants are followed by telephone at 9, 12, and 18 months to evaluate long-term adherence to the nutritional advice, general health, and menopausal symptoms.

Sex

Female

Minimum age

18 Years

Maximum age

60 Years

Inclusion Criteria:

* Women with a histological diagnosis of hormone-sensitive breast cancer
* Adjuvant anti-estrogen therapy (tamoxifen, LH-RH analogue, aromatase inhibitors) initiated at least 6 months prior to enrollment
* Women aged 18 to 60 years
* Patient willingness to continue hormonal therapy for the duration of the study
* Spontaneous or induced amenorrhea within the last 6 months
* Women experiencing 6 or more hot flashes per day or scoring at least 15 on the Greene Climacteric Scale (GCS) in the week prior to enrollment
* Willingness to participate and follow nutritional guidelines (applicable only to the nutritional intervention arm) after signing informed consent
* Performance status ≤1

Exclusion Criteria:

* women with a prior diagnosis of severe and pharmacologically uncontrolled depression, osteoporosis, hypercholesterolemia, and/or hypertension
* allergy or intolerance to vegetables of the Brassicaceae family (applicable only to the nutritional intervention arm)
* women with reported thyroid disorders
* women using serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors (venlafaxine), or anticonvulsants (gabapentin and gabatrin)
* ongoing chemotherapy or radiotherapy