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

NCT07842614 | Completed DMC

• 1 other identifier: 11753
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer; Menopausal Symptoms

Keywords

Brassicaceae; Menopausal Symptoms; Hot Flashes; Vasomotor Symptoms; Breast Cancer; Antiestrogen Therapy; Nutritional Intervention

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Vasomotor Symptom Score at 3 and 6 Months

  Vasomotor symptoms are assessed using the sum of the scores for question 19 (hot flashes) and question 20 (night sweats) of the recruitment questionnaire. Changes from baseline are assessed at 3 and 6 months and compared between the nutritional intervention and control groups.

  Baseline, 3 months, and 6 months

Study Arms (2)

Brassicaceae Nutritional Intervention

EXPERIMENTAL

Participants receive nutritional counseling to include at least five servings per week of vegetables belonging to the Brassicaceae family in their usual diet. Participants may choose the type of Brassicaceae vegetables and when to consume them.

Behavioral: Increased Dietary Intake of Brassicaceae Vegetables

Control Group

NO INTERVENTION

Participants undergo the study assessments but receive no specific nutritional advice to increase the consumption of Brassicaceae vegetables.

Interventions

Increased Dietary Intake of Brassicaceae Vegetables BEHAVIORAL

Participants receive nutritional counseling to include at least five servings per week of vegetables belonging to the Brassicaceae family in their usual diet. Participants may choose the type of Brassicaceae vegetables and when to consume them

Brassicaceae Nutritional Intervention

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Ospedaliero, Universitaria Pisana: lead

Study Sites (1)

Azienda Ospedaliero-Universitaria Pisana, U.O. Senologia

Pisa, Tuscany, 56126, Italy

Location

MeSH Terms

Conditions

Breast Neoplasms; Hot Flashes

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director

Model Details: Participants are randomized in a 1:1 ratio to either the nutritional intervention group or the control group, with stratification by age. Randomization is performed by the oncologist.

Study Record Dates

• First Submitted: September 21, 2026
• First Posted: September 25, 2026
• Study Start: October 30, 2020
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)