Can treatment with Cocculine improve the control of chemotherapy-induced emesis in early breast cancer patients? A randomized, multi-centered, double-blind, placebo-controlled Phase III trial

BMC Cancer

Isabelle Ray-Coquard⁴  Agathe Bajard³  Jean-Pierre Martin⁵  Xavier Pivot⁸  Jean-Paul Guastalla³  Thomas Bachelot³  Cécile Agostini⁶  Jean-Phillipe Jacquin¹  David Coeffic⁹  Anne-claire Hardy-Bessard²  Jocelyne Provençal⁷  David Pérol³ 

[1]Institut de cancérologie de la Loire, 108, avenue Albert-Raimond, Saint-Priest-en-Jarez, 42270, France

[2]Clinique armoricaine de Radiologie, 21 rue du Vieux Séminaire, Saint Brieuc, 22 000, France

[3]Centre Léon Bérard, 28 rue Laennec, Lyon Cedex 08, 69373, France

[4]Centre Léon Bérard, 28 rue Laennec, Lyon, 69008, France

[5]Hôpital Jean Mermoz, 55 avenue Jean Mermoz, Lyon, 69008, France

[6]Centre hospitalier Général, Chambéry, BP1125, 73011, France

[7]Centre hospitalier de la région d’Annecy, 1 avenue de l’hôpital, Annecy, BP90074, 74374, France

[8]Centre Hospitalier Universitaire, Boulevard Fleming, Besançon, 25030, France

[9]UMGEC, Service Institut Daniel Hollard, 12 Rue Docteur Calmette, Grenoble, 38028, France

关键词: Quality of life;    Nausea and vomiting;    Homeopathy;    Adjuvant chemotherapy;    Early breast cancer;   

Others  :  1080011
DOI  :  10.1186/1471-2407-12-603

 received in 2012-05-11, accepted in 2012-12-05,  发布年份 2012

【 摘 要 】

Background

Chemotherapy induced nausea and vomiting (CINV) remains a major problem that seriously impairs the quality of life (QoL) in cancer patients receiving chemotherapy regimens. Complementary medicines, including homeopathy, are used by many patients with cancer, usually alongside with conventional treatment. A randomized, placebo-controlled Phase III study was conducted to evaluate the efficacy of a complex homeopathic medicine, Cocculine, in the control of CINV in non-metastatic breast cancer patients treated by standard chemotherapy regimens.

Methods

Chemotherapy-naïve patients with non-metastatic breast cancer scheduled to receive 6 cycles of chemotherapy including at least three initial cycles of FAC 50, FEC 100 or TAC were randomized to receive standard anti-emetic treatment plus either a complex homeopathic remedy (Cocculine, registered in France for treatment of nausea and travel sickness) or the matching placebo (NCT00409071

clinicaltrials.gov

). The primary endpoint was nausea score measured after the 1^st chemotherapy course using the FLIE questionnaire (Functional Living Index for Emesis) with 5-day recall. Secondary endpoints were: vomiting measured by the FLIE score, nausea and vomiting measured by patient self-evaluation (EVA) and investigator recording (NCI-CTC AE V3.0) and treatment compliance.

Results

From September 2005 to January 2008, 431 patients were randomized: 214 to Cocculine (C) and 217 to placebo (P). Patient characteristics were well-balanced between the 2 arms. Overall, compliance to study treatments was excellent and similar between the 2 arms. A total of 205 patients (50.9%; 103 patients in the placebo and 102 in the homeopathy arms) had nausea FLIE scores > 6 indicative of no impact of nausea on quality of life during the 1^st chemotherapy course. There was no difference between the 2 arms when primary endpoint analysis was performed by chemotherapy stratum; or in the subgroup of patients with susceptibility to nausea and vomiting before inclusion. In addition, nausea, vomiting and global emesis FLIE scores were not statistically different at any time between the two study arms. The frequencies of severe (Grade ≥ 2) nausea and vomiting were low in our study (nausea: P: 17.6% vs C: 15.7%, p=0.62; vomiting: P: 10.8% vs C: 12.0%, p=0.72 during the first course).

Conclusion

This double-blinded, placebo-controlled, randomised Phase III study showed that adding a complex homeopathic medicine (Cocculine) to standard anti-emetic prophylaxis does not improve the control of CINV in early breast cancer patients.

【 授权许可】

   
2012 Pérol et al; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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