Evaluation of Homeopathic Treatment for Hot Flashes in Non Metastatic Breast Cancer (HBC)

Léon Bérard Center

Status and phase: Completed; Phase 3

Conditions: Breast Cancer

Treatments: Drug: BRN01; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01246427

ET2008-048

HBC

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 138 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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138 participants in 2 patient groups, including a placebo group

BRN01

Experimental group

Description:

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

Treatment:

Drug: BRN01

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo