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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

Phase 3
18 Years
90 Years
Open (Enrolling)
Breast Cancer

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Trial Information

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

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.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Evaluation of BRN01 efficacy in reducing hot flash score after 4 weeks of treatment

Outcome Description:

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).

Outcome Time Frame:

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).

Safety Issue:


Principal Investigator

Jean-Paul Guastalla, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre Leon Berard, France


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:




Start Date:

January 2010

Completion Date:

May 2015

Related Keywords:

  • Breast Cancer
  • Adjuvant hormonal therapy
  • Homeopathic treatment
  • Hot flashes
  • Quality of life
  • Hot flash score
  • Breast Neoplasms
  • Hot Flashes