Status:
COMPLETED
Evaluation of Homeopathic Treatment for Hot Flashes in Non Metastatic Breast Cancer
Lead Sponsor:
Centre Leon Berard
Collaborating Sponsors:
BOIRON
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
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.
Detailed 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 Rece...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT01246427
Start Date
January 1 2010
End Date
November 1 2014
Last Update
September 14 2016
Active Locations (9)
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1
Centre Hospitalier de Chambery
Chambéry, France
2
Centre Jean Perrin
Clermont-Ferrand, France
3
Centre Leon Berard
Lyon, France, 69373
4
Centre Hospitalier de Montelimar
Montélimar, France