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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Centre Leon Berard
Sponsor:
Collaborator:
BOIRON
Information provided by (Responsible Party):
Centre Leon Berard
ClinicalTrials.gov Identifier:
NCT01246427
First received: November 16, 2010
Last updated: January 2, 2014
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: BRN01
Drug: Placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Centre Leon Berard:

Primary Outcome Measures:
  • Evaluation of BRN01 efficacy in reducing hot flash score after 4 weeks of treatment [ 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). ] [ Designated as safety issue: No ]

    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).



Secondary Outcome Measures:
  • Evaluation of BRN01 efficacy in reducing the hot flash score after 8 weeks of treatment [ 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 8th week of the second period (placebo or BRN01). ] [ Designated as safety issue: No ]

    Treatment efficacy scores will be calculated as follows: (hot flash score on the 8th 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).


  • 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. [ Time Frame: 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). ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: 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). ] [ Designated as safety issue: No ]
  • Evaluation of quality of life in both arms [ Time Frame: 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) ] [ Designated as safety issue: No ]
  • Evaluation of patient satisfaction with the treatment and with the management of hot flashes. [ Time Frame: 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). ] [ Designated as safety issue: No ]
  • Evaluation of treatment tolerance [ Time Frame: 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) ] [ Designated as safety issue: No ]
  • Evaluation of patient compliance [ Time Frame: 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) ] [ Designated as safety issue: No ]

Estimated Enrollment: 138
Study Start Date: January 2010
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
Drug: 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 Comparator: 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
Drug: 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).

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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01246427

Contacts
Contact: Ellen Blanc +33 4 78 78 29 67 ellen.blanc@lyon.unicancer.fr

Locations
France
Centre Hospitalier de Chambery Recruiting
Chambery, France
Contact: Isabelle Cauvin         
Sub-Investigator: Cécile Agostini         
Sub-Investigator: Isabelle Cretinon         
Sub-Investigator: Philippe Fourneret         
Sub-Investigator: Joanne De Cornulier         
Sub-Investigator: Emmanuel Berland         
Sub-Investigator: Jocelyne Provençal         
Centre Jean Perrin Recruiting
Clermont Ferrand, France
Contact: Isabelle Van Praagh Doreau         
Sub-Investigator: Aurélie Bellière         
Sub-Investigator: Pascale Dubray Longeras         
Sub-Investigator: Marie Ange Mouret Reynier         
Sub-Investigator: Jean Marc Nabholtz         
Centre Leon Berard Recruiting
Lyon, France, 69373
Contact: Pierre Etienne Heudel, MD    +33 478 78 27 57    pierre-etienne.heudel@lyon.unicancer.fr   
Sub-Investigator: Paul Rebattu, MD         
Sub-Investigator: Pierre Biron, MD         
Sub-Investigator: Christelle Faure, MD         
Sub-Investigator: Nicolas Chopin, MD         
Sub-Investigator: Isabelle Ray-Coquard, MD         
Sub-Investigator: Olivier Tredan, MD         
Sub-Investigator: Thomas Bachelot, MD         
Sub-Investigator: Frederic Beurrier, MD         
Sub-Investigator: Christian Carrie, MD         
Sub-Investigator: Nicolas Carrabin, MD         
Centre Hospitalier de Montelimar Recruiting
Montelimar, France
Contact: Bernard Duvert         
Sub-Investigator: Ahmed Azzedine         
Sub-Investigator: Blaha BELGADI, MD         
Centre Hospitalier d'Annecy Recruiting
Pringy, France
Contact: Laetitia Stefani         
Centre Hospitalier de Roanne Recruiting
Roanne, France
Contact: Lionel Vincent         
Sub-Investigator: Patrice Le Rat         
Clinique Armoricaine de radiologie Recruiting
St Brieuc, France
Contact: Anne Claire Hardy Bessard         
Sub-Investigator: Dominique Besson         
Sub-Investigator: Bruno Lamezec         
Sub-Investigator: Pierre Luc Etienne         
Institut de Cancérologie Lucien Neuwirth Recruiting
St Priest en Jarez, France
Contact: Jean Philippe Jacquin         
Sub-Investigator: Camille Devanlay         
Sub-Investigator: Guillaume Clavreul         
Centre Hospitalier de Valence Recruiting
Valence, France
Contact: Dominique Dramais Marcel         
Sub-Investigator: Hélène Joosten         
Sponsors and Collaborators
Centre Leon Berard
BOIRON
Investigators
Principal Investigator: Pierre Etienne Heudel, MD Centre Leon Berard, France
  More Information

Publications:

Responsible Party: Centre Leon Berard
ClinicalTrials.gov Identifier: NCT01246427     History of Changes
Other Study ID Numbers: HBC, ET2008-048
Study First Received: November 16, 2010
Last Updated: January 2, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Leon Berard:
Adjuvant hormonal therapy
Homeopathic treatment
Hot flashes
Quality of life
Hot flash score

Additional relevant MeSH terms:
Breast Neoplasms
Hot Flashes
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 08, 2014