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

NCT01246427 | Completed Phase 3

• 2 other identifiers: HBCET2008-048
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 9

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.

Conditions

Breast Cancer

Keywords

Adjuvant hormonal therapy; Homeopathic treatment; Hot flashes; Quality of life; Hot flash score

Outcome Measures

Primary Outcomes (1)

• 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).

  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 Outcomes (7)

• Evaluation of BRN01 efficacy in reducing the hot flash score after 8 weeks of treatment

  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 the mean daily intensity of hot flashes during the run-in period and on the 4th and 8th weeks of treatment in both arms.

  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).

• 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.

  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 quality of life in both arms

  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 patient satisfaction with the treatment and with the management of hot flashes.

  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).

Study Arms (2)

BRN01

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

BRN01 DRUG

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).

BRN01

Placebo DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Leon Berard: lead
• BOIRON: collaborator

Study Sites (9)

Centre Hospitalier de Chambery

Chambéry, France

Location

Centre Jean Perrin

Clermont-Ferrand, France

Location

Centre Leon Berard

Lyon, 69373, France

Location

Centre Hospitalier de Montelimar

Montélimar, France

Location

Centre Hospitalier d'Annecy

Pringy, France

Location

Centre Hospitalier de Roanne

Roanne, France

Location

Clinique Armoricaine de radiologie

Saint-Brieuc, France

Location

Institut de Cancérologie Lucien Neuwirth

Saint-Priest-en-Jarez, France

Location

Centre Hospitalier de Valence

Valence, France

Location

Related Publications (26)

• Remontet L, Esteve J, Bouvier AM, Grosclaude P, Launoy G, Menegoz F, Exbrayat C, Tretare B, Carli PM, Guizard AV, Troussard X, Bercelli P, Colonna M, Halna JM, Hedelin G, Mace-Lesec'h J, Peng J, Buemi A, Velten M, Jougla E, Arveux P, Le Bodic L, Michel E, Sauvage M, Schvartz C, Faivre J. Cancer incidence and mortality in France over the period 1978-2000. Rev Epidemiol Sante Publique. 2003 Feb;51(1 Pt 1):3-30.

  PMID: 12684578 BACKGROUND

• Menegoz F, Black RJ, Arveux P, Magne V, Ferlay J, Buemi A, Carli PM, Chapelain G, Faivre J, Gignoux M, Grosclaude P, Mace-Lesec'h J, Raverdy N, Schaffer P. Cancer incidence and mortality in France in 1975-95. Eur J Cancer Prev. 1997 Oct;6(5):442-66. doi: 10.1097/00008469-199710000-00005.

  PMID: 9466116 BACKGROUND

• Coleman MP. Trends in breast cancer incidence, survival, and mortality. Lancet. 2000 Aug 12;356(9229):590-1; author reply 593. doi: 10.1016/S0140-6736(00)02593-9. No abstract available.

  PMID: 10950250 BACKGROUND

• Breast International Group (BIG) 1-98 Collaborative Group; Thurlimann B, Keshaviah A, Coates AS, Mouridsen H, Mauriac L, Forbes JF, Paridaens R, Castiglione-Gertsch M, Gelber RD, Rabaglio M, Smith I, Wardley A, Price KN, Goldhirsch A. A comparison of letrozole and tamoxifen in postmenopausal women with early breast cancer. N Engl J Med. 2005 Dec 29;353(26):2747-57. doi: 10.1056/NEJMoa052258.

  PMID: 16382061 BACKGROUND

• Finck G, Barton DL, Loprinzi CL, Quella SK, Sloan JA. Definitions of hot flashes in breast cancer survivors. J Pain Symptom Manage. 1998 Nov;16(5):327-33. doi: 10.1016/s0885-3924(98)00090-6.

  PMID: 9846028 BACKGROUND

• Stearns V, Ullmer L, Lopez JF, Smith Y, Isaacs C, Hayes D. Hot flushes. Lancet. 2002 Dec 7;360(9348):1851-61. doi: 10.1016/s0140-6736(02)11774-0.

  PMID: 12480376 BACKGROUND

• Couzi RJ, Helzlsouer KJ, Fetting JH. Prevalence of menopausal symptoms among women with a history of breast cancer and attitudes toward estrogen replacement therapy. J Clin Oncol. 1995 Nov;13(11):2737-44. doi: 10.1200/JCO.1995.13.11.2737.

  PMID: 7595732 BACKGROUND

• Fellowes D, Fallowfield LJ, Saunders CM, Houghton J. Tolerability of hormone therapies for breast cancer: how informative are documented symptom profiles in medical notes for 'well-tolerated' treatments? Breast Cancer Res Treat. 2001 Mar;66(1):73-81. doi: 10.1023/a:1010684903199.

  PMID: 11368413 BACKGROUND

• Lower EE, Blau R, Gazder P, Tummala R. The risk of premature menopause induced by chemotherapy for early breast cancer. J Womens Health Gend Based Med. 1999 Sep;8(7):949-54. doi: 10.1089/jwh.1.1999.8.949.

  PMID: 10534297 BACKGROUND

• McPhail G, Smith LN. Acute menopause symptoms during adjuvant systemic treatment for breast cancer: a case-control study. Cancer Nurs. 2000 Dec;23(6):430-43. doi: 10.1097/00002820-200012000-00005.

  PMID: 11128122 BACKGROUND

• Loprinzi CL, Zahasky KM, Sloan JA, Novotny PJ, Quella SK. Tamoxifen-induced hot flashes. Clin Breast Cancer. 2000 Apr;1(1):52-6. doi: 10.3816/cbc.2000.n.004.

  PMID: 11899390 BACKGROUND

• Love RR, Cameron L, Connell BL, Leventhal H. Symptoms associated with tamoxifen treatment in postmenopausal women. Arch Intern Med. 1991 Sep;151(9):1842-7.

  PMID: 1888251 BACKGROUND

• Linde K, Clausius N, Ramirez G, Melchart D, Eitel F, Hedges LV, Jonas WB. Are the clinical effects of homeopathy placebo effects? A meta-analysis of placebo-controlled trials. Lancet. 1997 Sep 20;350(9081):834-43. doi: 10.1016/s0140-6736(97)02293-9.

  PMID: 9310601 BACKGROUND

• Jonas WB, Kaptchuk TJ, Linde K. A critical overview of homeopathy. Ann Intern Med. 2003 Mar 4;138(5):393-9. doi: 10.7326/0003-4819-138-5-200303040-00009.

  PMID: 12614092 BACKGROUND

• Cucherat M, Haugh MC, Gooch M, Boissel JP. Evidence of clinical efficacy of homeopathy. A meta-analysis of clinical trials. HMRAG. Homeopathic Medicines Research Advisory Group. Eur J Clin Pharmacol. 2000 Apr;56(1):27-33. doi: 10.1007/s002280050716.

  PMID: 10853874 BACKGROUND

• Jonas WB. Researching alternative medicine. Nat Med. 1997 Aug;3(8):824-7. doi: 10.1038/nm0897-824. No abstract available.

  PMID: 9256264 BACKGROUND

• Guyatt GH, Sackett DL, Cook DJ. Users' guides to the medical literature. II. How to use an article about therapy or prevention. A. Are the results of the study valid? Evidence-Based Medicine Working Group. JAMA. 1993 Dec 1;270(21):2598-601. doi: 10.1001/jama.270.21.2598. No abstract available.

  PMID: 8230645 BACKGROUND

• Grol R, Grimshaw J. Evidence-based implementation of evidence-based medicine. Jt Comm J Qual Improv. 1999 Oct;25(10):503-13. doi: 10.1016/s1070-3241(16)30464-3.

  PMID: 10522231 BACKGROUND

• Barnes J, Ernst E. Complementary medicine. Br J Gen Pract. 1997 May;47(418):329. No abstract available.

  PMID: 9219418 BACKGROUND

• Clover A, Ratsey D. Homeopathic treatment of hot flushes: a pilot study. Homeopathy. 2002 Apr;91(2):75-9. doi: 10.1054/homp.2002.0004.

  PMID: 12371460 BACKGROUND

• Thompson EA, Reilly D. The homeopathic approach to the treatment of symptoms of oestrogen withdrawal in breast cancer patients. A prospective observational study. Homeopathy. 2003 Jul;92(3):131-4. doi: 10.1016/s1475-4916(03)00035-3.

  PMID: 12884894 BACKGROUND

• Thompson EA, Montgomery A, Douglas D, Reilly D. A pilot, randomized, double-blinded, placebo-controlled trial of individualized homeopathy for symptoms of estrogen withdrawal in breast-cancer survivors. J Altern Complement Med. 2005 Feb;11(1):13-20. doi: 10.1089/acm.2005.11.13.

  PMID: 15750359 BACKGROUND

• Relton C, Weatherley-Jones E. Homeopathy service in a National Health Service community menopause clinic: audit of clinical outcomes. J Br Menopause Soc. 2005 Jun;11(2):72-3. doi: 10.1258/136218005775544516.

  PMID: 15970019 BACKGROUND

• Bordet MF, Colas A, Marijnen P, Masson J, Trichard M. Treating hot flushes in menopausal women with homeopathic treatment--results of an observational study. Homeopathy. 2008 Jan;97(1):10-5. doi: 10.1016/j.homp.2007.11.005.

  PMID: 18194760 BACKGROUND

• Sloan JA, Loprinzi CL, Novotny PJ, Barton DL, Lavasseur BI, Windschitl H. Methodologic lessons learned from hot flash studies. J Clin Oncol. 2001 Dec 1;19(23):4280-90. doi: 10.1200/JCO.2001.19.23.4280.

  PMID: 11731510 BACKGROUND

• 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.

  PMID: 30194492 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Hot Flashes

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pierre Etienne Heudel, MD

  Centre Leon Berard, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2010
• First Posted: November 23, 2010
• Study Start: January 1, 2010
• Primary Completion: May 1, 2014
• Study Completion: November 1, 2014
• Last Updated: September 14, 2016

Record last verified: 2016-09

Locations

FR (9)