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

Primary Purpose

Breast Cancer

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
BRN01
Placebo
Sponsored by
Centre Leon Berard
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Adjuvant hormonal therapy, Homeopathic treatment, Hot flashes, Quality of life, Hot flash score

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Centre Hospitalier de Chambery
  • Centre Jean Perrin
  • Centre Leon Berard
  • Centre Hospitalier de Montelimar
  • Centre Hospitalier d'Annecy
  • Centre Hospitalier de Roanne
  • Clinique Armoricaine de radiologie
  • Institut de Cancérologie Lucien Neuwirth
  • Centre Hospitalier de Valence

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

BRN01

Placebo

Arm 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

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

Outcomes

Primary Outcome Measures

Evaluation of BRN01 efficacy in reducing hot flash score after 4 weeks of treatment
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
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.
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.
Evaluation of quality of life in both arms
Evaluation of patient satisfaction with the treatment and with the management of hot flashes.
Evaluation of treatment tolerance
Evaluation of patient compliance

Full Information

First Posted
November 16, 2010
Last Updated
September 13, 2016
Sponsor
Centre Leon Berard
Collaborators
BOIRON
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1. Study Identification

Unique Protocol Identification Number
NCT01246427
Brief Title
Evaluation of Homeopathic Treatment for Hot Flashes in Non Metastatic Breast Cancer
Acronym
HBC
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Leon Berard
Collaborators
BOIRON

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Adjuvant hormonal therapy, Homeopathic treatment, Hot flashes, Quality of life, Hot flash score

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
138 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BRN01
Arm Type
Experimental
Arm 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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm 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
Intervention Type
Drug
Intervention Name(s)
BRN01
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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).
Primary Outcome Measure Information:
Title
Evaluation of BRN01 efficacy in reducing hot flash score after 4 weeks of treatment
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).
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).
Secondary Outcome Measure Information:
Title
Evaluation of BRN01 efficacy in reducing the hot flash score after 8 weeks of treatment
Description
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).
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).
Title
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).
Title
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).
Title
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)
Title
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).
Title
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)
Title
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)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre Etienne Heudel, MD
Organizational Affiliation
Centre Leon Berard, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier de Chambery
City
Chambery
Country
France
Facility Name
Centre Jean Perrin
City
Clermont Ferrand
Country
France
Facility Name
Centre Leon Berard
City
Lyon
ZIP/Postal Code
69373
Country
France
Facility Name
Centre Hospitalier de Montelimar
City
Montelimar
Country
France
Facility Name
Centre Hospitalier d'Annecy
City
Pringy
Country
France
Facility Name
Centre Hospitalier de Roanne
City
Roanne
Country
France
Facility Name
Clinique Armoricaine de radiologie
City
St Brieuc
Country
France
Facility Name
Institut de Cancérologie Lucien Neuwirth
City
St Priest en Jarez
Country
France
Facility Name
Centre Hospitalier de Valence
City
Valence
Country
France

12. IPD Sharing Statement

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

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