Placebo-controlled Evaluation of the Homeopathic Drug BRN01 for the Treatment of Hot Flashes in Women With Non Metastatic Breast Cancer Treated by Adjuvant Hormonal Therapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 138
- 试验地点
- 9
- 主要终点
- Evaluation of BRN01 efficacy in reducing hot flash score after 4 weeks of treatment
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of a homeopathic treatment (BRN01) in reducing hot flash scores after 4 weeks of treatment.
详细描述
Chemotherapy is used as an adjuvant treatment for breast cancer, like hormone therapy in patients with hormone-sensitive breast cancer or immunotherapy in those with Human Epidermal growth factor Receptor 2 (HER2)-overexpressing cancer.
These adjuvant treatments reduce the risk of recurrence and metastasis. The side effects of hormone therapy are known and depend on the therapeutic strategy and the drugs used. The side effects of Tamoxifen are similar to menopausal symptoms: hot flashes (half of the female population), vaginal dryness or leukorrhea, nausea, irregular menstruation, benign ovarian cyst and, less frequently, weight gain. Aromatase inhibitors have the same side effects, though with lesser frequency and intensity. The incidence rate of hot flashes after adjuvant treatment in menopausal women with localized breast cancer is 60 to 65 %, and these reactions are very severe in one third of these women. Despite this fact, the management of hot flashes is not systematic and there is currently no therapeutic strategy with proven efficiency. BRN01 (Boiron laboratory) is a homeopathic remedy whose active ingredient is already present in other homeopathic drugs indicated for the management of menopausal hot flashes. BRN01 could reduce the intensity of the reaction in women with breast cancer receiving adjuvant hormonal treatment.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patient aged ≥ 18 years
- •Women with histologically proven non metastatic breast cancer
- •ECOG PS ≤ 1
- •Patient receiving adjuvant hormonal therapy for at least 1 month (aromatase inhibitor or Tamoxifen ± ovarian function suppression (Luteinizing Hormone Releasing Hormone agonist (LH-RH agonist), ovariectomy...))
- •Patient complaining of hot flashes with moderate to severe intensity, affecting quality of life, for at least 1 month before inclusion
- •Patient agreement not to start another hot flash treatment during the study (allopathic treatment, E vitamin, dietary supplement, phytotherapy, acupuncture...)
- •Patient able to understand, read and write French
- •Mandatory affiliation with a health insurance system
- •Signed, written informed consent
排除标准
- •Ongoing chemotherapy or radiotherapy, or treatment planned to begin during the study
- •Patient with a condition known to induce hot flashes such as hyperthyroidism, diabetes, adrenal tumor, enteric carcinoid tumor, mastocytosis...
- •Patient with severe renal failure, severe hepatic failure, or cardiovascular disease
- •Patient with one of the following contraindications:
- •known hypersensitivity to one of the components of the study drug
- •galactose, fructose intolerance
- •Lapp lactase deficiency, isomaltase invertase deficiency
- •Glucose or galactose malabsorption syndrome
- •Follow up impossible because of social, familial, geographical or psychological reasons
- •Patient suspected of poor compliance with protocol or treatment
- •Participation in another biomedical research trial in the same indication, or administration of an experimental drug in the same indication in the 30 days before inclusion
研究组 & 干预措施
BRN01
A 2 to 4 weeks run-in period is planned, during which all patients receive single blinded "hot flash evaluation treatment" which is actually a placebo (2 tablets every morning and every evening during 2 to 4 weeks). At the end of this period, the hot flash score is calculated. If the score is ≥10, the patient can be randomized to one of the 2 arms:
- Experimental: BRN01
- Placebo Comparator: Placebo
干预措施: BRN01 (Drug)
Placebo
A 2 to 4 weeks run-in period is planned, during which all patients receive single blinded "hot flash evaluation treatment" which is actually a placebo (2 tablets every morning and every evening during 2 to 4 weeks). At the end of this period, the hot flash score is calculated. If the score is ≥10, the patient can be randomized to one of the 2 arms:
- Experimental: BRN01
- Placebo Comparator: Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Evaluation of BRN01 efficacy in reducing hot flash score after 4 weeks of treatment
时间窗: The patients are instructed to record the number and intensity of hot flashes in a self-evaluation booklet every day during the 2nd week of the first period (run-in period) and during the 4th week of the second period (placebo or BRN01).
The hot flash score is equal to: (number of hot flashes/day) x (mean intensity/day). Treatment efficiency scores will be calculated as follows: (hot flash score on the 4th week of the second period)-(hot flash score on the 2nd week of the first period). Then efficiency scores will be compared between the 2 arms (placebo versus BRN01).
次要结局
- Evaluation of patient satisfaction with the treatment and with the management of hot flashes.(The patients are instructed to record all new hot flash treatments started, as well as their satisfaction with their management, on the 7th day of each evaluation period (2nd week of the run-in period, 4th and 8th weeks of the second period).)
- Evaluation of the mean daily intensity of hot flashes during the run-in period and on the 4th and 8th weeks of treatment in both arms.(The patients are instructed to record the intensity of hot flashes in a self-evaluation booklet, daily, during the 2nd week of the first period (run-in period), and during the 4th and 8th weeks of the second period (placebo or BRN01).)
- Evaluation of quality of life in both arms(The patients are instructed to complete quality of life items on the 7th day of each evaluation period (2nd week of the run-in period, 4th and 8th weeks of the second period))
- Evaluation of the mean daily frequency of hot flashes during the run-in period and on the 4th and 8th weeks of treatment in both arms.(The patients are instructed to record the number of hot flashes in a self-evaluation booklet, daily, during the 2nd week of the first period (run-in period), and during the 4th and 8th weeks of the second period (placebo or BRN01).)
- Evaluation of patient compliance(The number of remaining tablets will be counted at each visit (planned during the 3rd week or the 4th week of the run-in period and during the 9th week or the 10th week of the second period))
- Evaluation of BRN01 efficacy in reducing the hot flash score after 8 weeks of treatment(The patients are instructed to record the number and intensity of hot flashes in a self-evaluation booklet every day during the 2nd week of the first period (run-in period) and during the 8th week of the second period (placebo or BRN01).)
- Evaluation of treatment tolerance(Side effects are registered by the oncologist at each visit (planned during the 3rd week or the 4th week of the run-in period and during the 9th week or the 10th week of the second period))