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ORIGINAL ARTICLE
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
Pierre-Etienne Heudel
1,2
&Isabelle Van Praagh-Doreau
3
&Bernard Duvert
4
&Isabelle Cauvin
5
&
Anne-Claire Hardy-Bessard
6
&Jean-Philippe Jacquin
7
&Laetitia Stefani
8
&Lionel Vincent
9
&Dominique Dramais
10
&
Jean-Paul Guastalla
1
&Ellen Blanc
11
&Aurélie Belleville
11
&Emilie Lavergne
11
&David Pérol
1
Received: 7 September 2017 /Accepted: 30 August 2018 / Published online: 7 September 2018
#Springer-Verlag GmbH Germany, part of Springer Nature 2018
Abstract
Purpose Endocrine therapy (ET) used to reduce the risk of recurrence in hormone receptor-expressing disease (75% of breast
cancers) is associated with worsening of climacteric symptoms with a negative impact on quality of life (QoL). Homeopathy
might allow a better management of hot flushes (HF).
Methods In this multicenter randomized double-blind placebo-controlled phase III study (ClinicalTrials.gov NCT01246427), we
enrolled ≥18 years old women with histologically proven non metastatic localized breast cancer, with Eastern Cooperative
Oncology Group-Performance Status (ECOG-PS) ≤1, treated for at least 1 month with adjuvant ET, and complaining about
moderate to severe HF. Patients should not be scheduled for chemotherapy or radiotherapy, and had no associated pathology
known to induce HF. After a 2- to 4-week placebo administration, we randomly assigned (1:1) patients with HFS ≥10 using an
interactive web-based centralized platform to BRN-01 homeopathic medicine complex (Actheane®) in arm A or Placebo (Arm
P). Randomization was stratified by adjuvant ET (taxoxifen/aromatase inhibitor) and recruiting site. HF scores (HFS) were
calculated as the mean of HF frequencies before randomization, at 4, and at 8 weeks post-randomization (pre-, 4w,- and 8w-)
weighted by a 4-level intensity scale. Primary endpoint was assessed at 4-week post-randomization, as the variation between pre-
and 4w-HFS. Secondary endpoints included HFS variation between pre- and 8w-HFS, compliance and tolerance assessed
8 weeks after randomization, and QoL and satisfaction assessed at 4- and 8-week post-randomization.
Results Two hundred ninety-nine patients were included, and 138 (46.2%) randomized (A, 65; P, 73). Median 4w-HFS absolute
variation (A, −2.9; P, −2.5 points, p= 0.756) and relative decrease (A, −17%; P, −15%, p= 0.629) were not statistically
different. However, 4w-HFS decreased for 46 (75%) in A vs 48 (68%) patients in P arm. 4w-QoL was stable or improved for
respectively 43 (72%) vs 51 (74%) patients (p=0.470).
Electronic supplementary material The online version of this article
(https://doi.org/10.1007/s00520-018-4449-x) contains supplementary
material, which is available to authorized users.
*Pierre-Etienne Heudel
PierreEtienne.HEUDEL@lyon.unicancer.fr
1
Department of Medical Oncology, Centre Léon Bérard, 28 rue
Laennec, 69373 Lyon Cedex 08, France
2
Centre Léon Bérard, 28 rue Laennec, 69008 Lyon, France
3
Centre Jean Perrin, 58, Rue Montalembert,
63011 Clermont-Ferrand, France
4
Centre Hospitalier, 3 Rue Adhémar, 26200 Montélimar, France
5
Centre Hospitalier, BP1125, 73011 Chambéry, France
6
Clinique Armoricaine de Radiologie, 21 rue du Vieux Séminaire,
22000 Saint Brieuc, France
7
Institut de Cancérologie Lucien Neuwirth, 108, avenue
Albert-Raimond, 42270 Saint-Priest-en-Jarez, France
8
Centre hospitalier de la région d’Annecy, 1 avenue de l’hôpital,
BP90074, 74374 Annecy, France
9
Centre hospitalier de Roanne, 28, Rue de Charlieu,
42300 Roanne, France
10
Centre hospitalier, 179, Boulevard Maréchal Juin,
26000 Valence, France
11
Department of Clinical Research and Innovation, Centre Léon
Bérard, 28 rue Laennec, 69373 Lyon Cedex 08, France
Supportive Care in Cancer (2019) 27:1879–1889
https://doi.org/10.1007/s00520-018-4449-x
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