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

• Register: ClinicalTrials.gov
• Last refreshed on: 26 September 2016
• Main ID: NCT01246427
• Date of registration: 16/11/2010
• Prospective Registration: No
• Primary sponsor: Centre Leon Berard
• Public title: Evaluation of Homeopathic Treatment for Hot Flashes in Non Metastatic Breast Cancer HBC
• Scientific 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
• Date of first enrolment: January 2010
• Target sample size: 138
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01246427
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

France

Contacts

• Name: Pierre Etienne Heudel, MD
• Affiliation: Centre Leon Berard, France

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Breast Cancer

Intervention(s)

Drug: BRN01

Drug: Placebo

Primary Outcome(s)

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).]

Secondary Outcome(s)

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).]

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).]

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)]

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)]

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)]

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).]

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).]

Secondary ID(s)

ET2008-048

HBC

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

BOIRON