Evaluation of Homeopathic Treatment for Hot Flashes in Non Metastatic Breast Cancer
NCT ID: NCT01246427
Last Updated: 2016-09-14
Study Results
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Basic Information
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COMPLETED
PHASE3
138 participants
INTERVENTIONAL
2010-01-31
2014-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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
BRN01
2 tablets every morning and every evening during 8 to 10 weeks. Each patient will receive 1 set of 5 treatment boxes (60 tablets/box).
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
Placebo
2 tablets every morning and every evening during 8 to 10 weeks. Each patient will receive 1 set of 5 treatment boxes (60 tablets/box).
Interventions
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BRN01
2 tablets every morning and every evening during 8 to 10 weeks. Each patient will receive 1 set of 5 treatment boxes (60 tablets/box).
Placebo
2 tablets every morning and every evening during 8 to 10 weeks. Each patient will receive 1 set of 5 treatment boxes (60 tablets/box).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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BOIRON
INDUSTRY
Centre Leon Berard
OTHER
Responsible Party
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Principal Investigators
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Pierre Etienne Heudel, MD
Role: PRINCIPAL_INVESTIGATOR
Centre Leon Berard, France
Locations
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Centre Hospitalier de Chambery
Chambéry, , France
Centre Jean Perrin
Clermont-Ferrand, , France
Centre Leon Berard
Lyon, , France
Centre Hospitalier de Montelimar
Montélimar, , France
Centre Hospitalier d'Annecy
Pringy, , France
Centre Hospitalier de Roanne
Roanne, , France
Clinique Armoricaine de radiologie
Saint-Brieuc, , France
Institut de Cancérologie Lucien Neuwirth
Saint-Priest-en-Jarez, , France
Centre Hospitalier de Valence
Valence, , France
Countries
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References
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Heudel PE, Van Praagh-Doreau I, Duvert B, Cauvin I, Hardy-Bessard AC, Jacquin JP, Stefani L, Vincent L, Dramais D, Guastalla JP, Blanc E, Belleville A, Lavergne E, Perol D. Does a homeopathic medicine reduce hot flushes induced by adjuvant endocrine therapy in localized breast cancer patients? A multicenter randomized placebo-controlled phase III trial. Support Care Cancer. 2019 May;27(5):1879-1889. doi: 10.1007/s00520-018-4449-x. Epub 2018 Sep 7.
Other Identifiers
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ET2008-048
Identifier Type: -
Identifier Source: secondary_id
HBC
Identifier Type: -
Identifier Source: org_study_id
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