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临床试验/NCT07842614
NCT07842614已完成不适用

Evaluation of the Benefits of Brassicaceae on Menopausal Symptoms in Patients With a History of Breast Cancer Treated With Anti-estrogens.

Azienda Ospedaliero, Universitaria Pisana1 个研究点 分布在 1 个国家目标入组 81 人开始时间: 2020年10月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
81
试验地点
1
主要终点
Change From Baseline in Vasomotor Symptom Score at 3 and 6 Months

研究概览

简要总结

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.

详细描述

Breast cancer treatment in women of childbearing age may require antiestrogen therapy, which can result in iatrogenic menopause. Vasomotor symptoms, particularly hot flashes and night sweats, are among the most common symptoms of this condition and may substantially affect patients' quality of life. The sudden reduction in estrogen levels may also be associated with increased cardiovascular risk and alterations in bone formation and resorption, potentially contributing to osteopenia and osteoporosis.

Nutritional interventions are of particular interest in breast cancer survivors. Vegetables belonging to the Brassicaceae family are rich in micronutrients, vitamins, fiber, folates, glucosinolates, and other bioactive compounds. Glucosinolates are converted into isothiocyanates through the action of myrosinase or the intestinal microbiota. Isothiocyanates have been shown to release hydrogen sulfide (H2S) in the presence of organic thiols, suggesting that some of the potential beneficial effects associated with glucosinolate-rich vegetables may involve the H2S pathway.

Brassicaceae vegetables also contain compounds, including thiocyanates and goitrin, that may potentially affect thyroid function. However, available preclinical and clinical evidence indicates that the amounts generally consumed as part of the diet are not expected to reach levels associated with clinically relevant thyroid toxicity. Thyroid-related conditions are therefore considered in the eligibility criteria of the study.

The BRASSICA study is a randomized, controlled, parallel-group nutritional intervention study designed to evaluate the effect of increasing the dietary intake of Brassicaceae vegetables on menopausal symptoms in women with histologically confirmed hormone-sensitive breast cancer receiving adjuvant antiestrogen therapy. Participants are randomized in a 1:1 ratio, with stratification according to age, to either a nutritional intervention group or a control group. Randomization is performed by the oncologist.

The primary objective is to evaluate whether the inclusion of at least five servings per week of vegetables belonging to the Brassicaceae family can improve vasomotor menopausal symptoms, particularly hot flashes, compared with a control group receiving no specific dietary advice regarding Brassicaceae intake. Secondary objectives include the evaluation of other menopausal symptoms and cardiovascular and osteopenic risk factors.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

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.

干预措施: Increased Dietary Intake of Brassicaceae Vegetables (Behavioral)

Control Group

No Intervention

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

结局指标

主要结局

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

时间窗: Baseline, 3 months, 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Matteo Ghilli

Medical Director

Azienda Ospedaliero, Universitaria Pisana

研究点 (1)

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