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

Abstract

BackgroundChemotherapy 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.MethodsChemotherapy-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 1st 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.ResultsFrom 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 1st 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).ConclusionThis 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.

A Systematic Review of Controlled Trials of Homeopathy in Adverse Effects of Radiotherapy and Chemotherapy in Cancer

“…▪ Study characteristics: Five randomised, double-blind, placebo-controlled trials [21][22][23][24][25] 1 randomised, open-label, placebo-controlled trial; 26 1 open pragmatic randomised controlled trial 7 and rest 1 single blind randomised study 27 (►Table 4) of homeopathy in adverse effects of radiotherapy and chemotherapy in carcinoma were identified. Thus, the level of evidence was graded as A (strong scientific evidence; i.e.…”

“…This review is the further update of Kassab's review by addition of three new papers by Frass, 7 Sencer 21 and Pérol. 22 Alongside, model validity has been evaluated of all the trials by newly developed Mathie's criteria. All these were missing in Kassab's review 2009.…”

Homeopathy: Curative, Concurrent and Supportive Cancer Treatment Potential

“…Nausea, vomiting, and overall emesis was measured by Functional Living Index for emesis (FLIE) scores [31]. Analysis was by Mann-Whitney U test, Pearson's chi-square test, or Fisher's exact test [31].…”

“…A Phase III RCT, Jadad/Oxford score ≥ 3/5, of Cocculine, a complex homeopathic remedy registered in France for nausea and travel sickness treatment was performed with 431 non-metastatic breast cancer patients before starting six cycles of chemotherapy beginning with three or more cycles of 5-Flurouracil, adriamycin, and cyclophosphamide (FAC 50), 5-Flurouracil, epirubicin, and cyclophosphamide (FEC 100), or Taxotere, adriamycin, and cyclophosphamide (TAC) did not find an effect on nausea, vomiting, global emesis, or quality of life [31]. Cocculine, is comprised of Cocculus indicus 4 CH, Nux vomica 4 CH, Petroleum 4 CH, and Tabacum 4 CH [31].…”

“…Cocculine, is comprised of Cocculus indicus 4 CH, Nux vomica 4 CH, Petroleum 4 CH, and Tabacum 4 CH [31]. Nausea, vomiting, and overall emesis was measured by Functional Living Index for emesis (FLIE) scores [31].…”